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{\info{\title The Life of the Abortion Pill in the United States}{\author PC/486}{\operator Faculty Library}{\creatim\yr2001\mo2\dy23\hr15\min50}{\revtim\yr2001\mo2\dy23\hr15\min50}{\printim\yr2000\mo4\dy19\hr21\min39}{\version2}{\edmins0}{\nofpages2}
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\par }}{\*\pnseclvl1\pnucrm\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl2\pnucltr\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl3\pndec\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl4\pnlcltr\pnstart1\pnindent720\pnhang{\pntxta )}}
{\*\pnseclvl5\pndec\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl6\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl7\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl8
\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl9\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}\pard\plain \qc\sl480\slmult0\widctlpar\adjustright \cgrid {The Life of the Abortion Pill in the United States
\par Julie A. Hogan
\par 
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab Eleven years after mifepristone}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  Mifepristone is the generic name for RU-486, the designation given the drug by its French maker, Roussel-Uclaf.}}}{
, the drug that chemically induces abortion and hence coined the abortion pill, was approved for use in France, American women still do not have access to the drug, although women in at least ten other nations do.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  Mifepristone has been available in Great Britain since 1991, China and Sweden since 1992, and Austria, Belgium, Denmark, Finland, Germany, Greece, the Netherlands, and Spain since 1999.  }{\i See}{ }{\i Reproductive He
alth Product Development/Medical Abortion Frequently Asked Questions}{ (last modified Dec. 22, 1999) <http://www.popcouncil.org/faqs/abortion.html>.}}}{  In 1988, Americans thought the "}{\i Abortion Pill [was] on the Horizon}{."}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Lloyd Shearer, }{\i Abortion Pill on the Horizon}{, T}{\scaps he}{ R}{\scaps ecord}{ (Northern New Jersey), Mar. 20, 1988, at 14.}}}{
  In 1993, almost five years later, American women still did not have access to the drug, although many women's hopes were raised by newspaper headlines claiming that the "}{\i Door May Be Open for [the] Abortion Pill to Be Sold in [the] U.S.}{"}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i E.g.,}{ Philip J. Hilts, }{\i Door May Be Open for Abortion Pill to Be Sold in U.S.}{, N.Y. T}{\scaps imes}{
, Feb. 25, 1993, at A1 [hereinafter Hilts, }{\i Door May Be Open}{].}}}{ and newspaper accounts predicting that mifepristone would be available in the United States in 1996.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Katherine Q. Seelye, }{\i Accord Opens Way for Abortion Pill in U.S. in 2 Years}{, }{\scaps N.Y. Times}{, May 17, 1994, at A1 [hereinafter Seelye, }{\i Accord Opens Way}{]; Adam Pertman, }{\i 
Arrival of RU-486 Could Intensify Abortion Debate}{, }{\scaps Boston Globe}{, May 22, 1994, at 1.}}}{  In 1996, the headlines reported that the "}{\i Approval of [the] Abortion Pill by the FDA [was] Likely Soon.}{"}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Shankar Vedantam, }{\i Approval of Abortion Pill by the FDA Is Likely Soon}{, S}{\scaps an }{D}{\scaps iego}{ U}{\scaps nion}{-T}{\scaps rib.}{, July 20, 1996, at A1.  }{\i 
See also}{ Julia Duin, }{\i Abortion 'Pill' Gets Panel OK Final Approval by FDA Seen Near}{, W}{\scaps ash. }{T}{\scaps imes}{, July 20, 1996, at A1. }}}{
  Yet, mifepristone was still not available in 1999, and newspaper headlines were less optimistic about predictions of its availability.  For example, a headline in }{\i The Washington Post}{ on March 23, 1999 read "}{\i 
Abortion Pill Inches Closer to Production; American Marketer Hopeful that Drug Will Be Available by Year End}{".}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Marc Kaufman, }{\i 
Abortion Pill Inches Closer to Production; American Marketer Hopeful that Drug Will Be Available by the End of the Year}{, W}{\scaps ash. }{P}{\scaps ost}{, Mar. 23, 1999, at Z7.}}}{
  As of March 2000, one year later, the United States Food and Drug Administration, the FDA, has still not approved mifepristone.  The question is why not.
\par \tab During the last eleven years, the efforts of those fighting to make mifepristone available in the United States have been thwarted by those fighting just as valiantly to keep it out.  The struggle between the two groups is evi
dent in every decision made, be it by the patent owner, the manufacturer, the FDA, or the President, regarding the drug's future and approval in the United States.  This paper will examine the ideology behind the struggle of these two groups and its effec
t
 on the life of the abortion pill, mifepristone, in the United States.  Part I will describe how mifepristone works to chemically induce an abortion, review the safety and effectiveness of the drug, and discuss other medical uses of the drug.  Part II wil
l
 identify the key players in the struggle to bring mifepristone to the United States and discuss the motivations and ideologies behind each groups' efforts.  Part III will review the history of mifepristone in France, from its invention to its approval.  
Part IV will discuss the history of mifepristone in the United States and examine the impact of the political struggle regarding the drug on mifepristone's availability (or lack thereof) in the United States.  
\par }\pard \qc\sl480\slmult0\widctlpar\adjustright {
\par Part I
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\i A.  How Mifepristone Works}{
\par \tab Mifepristone is an antihormone and more specifically, a progesterone antagonist.  Essentially, mifepristone interrupts hormonal messages by interfering with the hormones function in the body.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{,}{\i  e.g.}{, E}{\scaps tienne}{-E}{\scaps mile}{ B}{\scaps aulieu}{ with M}{\scaps ort}{ R}{\scaps osenblum}{, T}{\scaps he}{ "A}{\scaps bortion}{ P}{\scaps ill}{" 16-17 (1991).}}}
{  Hormones must bind with corresponding receptors in order to function and emit the correct message.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., id. }}}{
  Progesterone is a hormone essential to the maintenance of pregnancy.  Before implantation, progesterone thickens the uterine lining, making it hospitable; after implantation, more progesterone is secreted, which sends a message
 to the brain to suppress the next ovulation; and as the embryo develops into a fetus, the placenta secretes progesterone, which calms the uterine contractions, protecting the embryo from being dislodged.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., id.}{ at 13.}}}{  Mifepristone is able to terminate pregnancy by binding to progesterone receptors and blocking the work of the hormone.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., id.}{ at 16-17.}}}{
  The man credited with the invention of mifepristone, Dr. Etienne-Emile Baulieu, analogizes the mifepristone to a false key; the mifepristone is able to enter the uniquely fashioned key hole, the receptor, instead of the progesterone.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 17.}}}{  The progesterone, which is secreted, circulates, but it has no effect.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }}}{  Deprived of the essential progesterone action, the gestation process cannot continue.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}}}{  The mifepristone will break down the embryo's bond to the uterine wall.  Contractions will begin, since the progesterone did not work to calm the uterine muscles, and the cervix will soften and widen.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{  A menstrual like blood flow will ensue and the embryo will be washed from the body.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{              
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i B.  Safety and Effectiveness
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab 
The first clinical trial was conducted in 1982 by Dr. Walter Herrmann in Geneva;  9 out of 11 women, administered mifepristone in a dose of 200 milligrams a day for four days, successfully terminated their pregnancy.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 85.  Also see Beatrice Couzinet et al., }{\i Termination of Early Pregnancy by the Progesterone Antagonist RU486 (Mifepristone) (Original Article)}{, 315 N}{
\scaps ew}{ E}{\scaps ng}{. J. M}{\scaps ed}{. 1565 (1986) for results of study on 100 women administered mifepristone alone; mifepristone failed to cause an abortion in 15 of the 100 women.}}}{  Duri
ng this study, Herrmann noted that the rate of prostaglandin in the blood went up during the termination of the pregnancy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ B}{\scaps 
aulieu}{,}{\i  supra }{note 8, at 85.}}}{  Dr. Baulieu and his colleagues immediately combined the administration of mifepristone with a dose of prostaglandin.  Prostaglandin
 increases the uterine contractions, enhancing the effectiveness of the mifepristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 210-211.}}}{
  In the late eighties and early nineties in France, mifepristone was administered in combination with sulprostone or gemeprost.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{
Louise Silvestre et al., }{\i Voluntary Interruption of Pregnancy with Mifepristone (RU 486) and a Prostaglandin Analogue:  A Large-Scale French Experience (Original Article)}{, 322 N}{\scaps ew}{ E}{\scaps ng}{. J. M}{\scaps ed}{
. 645 (1990) (discussing results of study, with overall efficacy rate of 96%, on women administered mifepristone in combination with sulprostone or gemeprost).}}}{  The use of sulprostone was discontinued
 after one death from heart failure after administration of mifepristone and sulprostone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\b  }{\i See}{\b  }{
Reproductive Health Advisory Committee, }{\i New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy }{
40 (July 19, 1996) (testimony of Irving M. Spitz, M.D.) (on file with author and available from Center for Drug Evaluation and Res
earch) [hereinafter Advisory Committee].  In March of 1991, a 31 year old woman in Northern France died of heart failure after an injection of sulprostone following mifepristone administration.  The prostaglandin, sulprostone, affects all smooth muscles i
n the body, including those of the circulatory system.  }{\i See}{ B}{\scaps aulieu}{, }{\i supra}{ note 8, at 100.}}}{
  Dr. Baulieu and his colleagues then began testing mifepristone with misoprostol, an orally administered prostaglandin rather than the intramuscular or intravaginal prostaglandins administered previously.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\b   }{\i See}{ Advisory Committee, }{\i supra}{ note 21, at 24 (testimony of Irving M. Spitz, M.D.).}}}{  Misoprostol is available in 45 countries and is relatively inexpensive.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i  See id.}}}{  In addition, it is believed to be safer with regards to cardiovascular complications and more convenient to store and administer.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{Allan Rosenfield, }{\i Mifepristone (RU 486) In the United States - - What Does the Future Hold?}{, 328 New E}{\scaps ng}{. J. M}{
\scaps ed.}{ 1560, 1560 (1993).}}}{\tab 
\par \tab Mifepristone will be used in combination with misoprostol, if and when it becomes available in the United States, according to the new drug application, the NDA, submitted to the FDA for drug approval.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Advisory Committee, }{\i supra}{ note 21, at 25 (testimony of Irving M. Spitz, M.D.).}}}{  The NDA focuses on three clinical studies, two conducted in
 France and one in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  
\par \tab The first French study, study 1, enrolled 1,286 women with a duration of gestation of 49 days or less; the second, study 2, enrolled 2,480 women, 492 with a duration of gestation of 49 days or less, the remainder w
ith duration of gestation of 50 to 69 days.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 25-27.}}}{
  Each study consisted of three visits.  In the first visit, the women were given 600 milligrams of mifepristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id. }{at 25-26.}}}{
  On the second visit, which was approximately 48 hours after the first visit, the women were given 400 milligrams of misoprostol and asked to remain in the clinic for four hours.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{  In study 2, if a woman had not had a medical termination within 3 hours, she was given an extra dose of 200 milligrams of misoprostol.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 26.}}}{  In both studies, the women were to return two weeks later for a third visit to determine the results of the pregnancy termination.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 25-26.}}}{  Analysis of the data indicated that the results were identical whether the women had a single dose of misoprostol or an extra dose.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 28.  Researchers do not recommend the second dose of misoprostol because it increases cramping and bleeding but does not increase efficacy.  }{
\i See id. }{at 47 (testimony of C. Wayne Bardin, M.D.).}}}{  Combining the studies,  there was a complete medical termination of pregnancy within 95.5% of the women with duration of gestation of 49 days or less.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 28 (testimony of Irving M. Spitz, M.D.). }}}{
  Of the 4.5% who did not have a complete medical termination, 1.3% had a continuing pregnancy that was subsequently terminated b
y dilation and curettage or vacuum aspiration, 2.9% had an incomplete abortion, and 0.3% required dilation and curettage or vacuum aspiration for bleeding.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{\i   See id. }}}{  In over 75% of the women, the medical termination was complete within 24 hours of misoprostol administration.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See id.}{ at 28-29.}}}{  
\par \tab The Population Council, a research institution dedicated to improving women's reproductive health, conducted the clinical trial in the United States from the fall of 1994 to the fall of 1995.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See }{Irving M. Spitz et al., }{\i Early Pregnancy Termination with Mifepristone and Misoprostol in the United States (Original Article)}{, 338 N}{\scaps ew}{ E}{\scaps ng}{. J. M}{\scaps 
ed}{. 1241, 1241 (1998) [hereinafter Spitz, }{\i Early Pregnancy Termination}{].}}}{  2,121 women with a duration of gestation less than 63 days participated in the study at 17 centers throughout the United States.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  The study followed the same protocol, or regimen, as that in the first French study.  Women were given 600 milligrams of mifepristone on their first visit; two days later, women returned and were administered 400 milligrams of misoprostol.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  Women then made a third appointment to return 15 days later for a final assessment.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{  The results of this United States clinical trial confirmed those of the French studies.  Pregnancy 
was terminated in 92% of the women with a duration of gestation less than 49 days.  As in the French study, a steady decline in the frequency of termination of pregnancy was noted with the increasing duration of gestation (i.e. pregnancy was terminated in
 only 83% of the women with duration of gestation for 50 to 56 days).}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at}{\b  }{1242; Advisory Committee, }{\i supra}{
 note 21, at 30 (testimony of Irving M. Spitz, M.D.).}}}{  In addition, within 24 hours of the administration of the misoprostol, 75% of the women had expelled the embryo and the medical termination was complete.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Spitz, }{\i Early Pregnancy Termination}{, }{\i supra}{ note 36, at 1243.}}}{      
\par \tab These clinical studies indicate that mifepristone, administered in combination with misoprostol, is highly effective in terminating pregnancy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  The Reproductive Health Advisory Committee voted 6-2 that the French studies indicate that mifepristone is effective for use as an abortifacient.  }{\i See}{ Advisory Committee, }{\i supra }{note 21, at 277-278. }{\i  See also}{ discussion }{\i infra }{
Part IV.G.}}}{  Such clinical trials must also prove the administration of such combination is safe.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  The Reproductive Health Advisory Committee voted 7-0, with one abstention, that the French studies indicate that mifepristone is safe for use as an abortifacient.  }{\i See id.}{ at 284-286. }{\i  See also}{ discussion }{\i infra}{ Part IV.G.}}}{
  Animal studies, conducted prior to the above clinical studies, show no toxic effects in animals that would be reflected in women.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{
 at 46 (testimony of C. Wayne Bardin, M.D.).  The FDA approved misoprostol, hence deeming it safe for use, in December of 1989.  }{\i See}{ Food and Drug Administration, }{\i Misoprostol Approval}{
 (visited  Mar. 27, 2000) <http:www.fda.gov/bbs/topics/NEWS/NEW00142.html>.}}}{  In the three studies discussed above, there were no deaths or serious cardiovascular outcomes.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  An Iowa doctor highly publicized one particular incident in which he 
reported "one of his patients lost more than half her blood, came close to death, and needed surgery" two weeks after taking mifepristone.  Tom Carney, }{\i 'Abortion Pill' Test Goes Awry for One Patient}{, }{\scaps Des Moines Reg.}{
, Sept. 21, 1995, Metro, at 1.  The doctor, Dr. Mark Louviere, believed reports that claimed no complications occurred in the Iowa clinical testing were misleading. }{\i  See id.  }{
A spokeswoman for the Population Council insisted that there were no serious complications and that such an incident was "within the context of what happened before."  }{\i Id.}{
  Planned Parenthood, the testing site at which the patient was administered the mifepristone, reported that the patient was unable to return for her third visit. }{\i  See}{ Advisory Committee, }{\i supra}{ note 21, at 2
34 (testimony of Gloria Feldt, president of Planned Parenthood Federation of America).  Dr. Louviere concedes that if the patient had been able to return for her third visit, she probably would have been managed appropriately.  }{\i See id. }{
at 235 (testimony of Mark Louviere, M.D.).}}}{  All of the "adverse events"}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  Dr. Bardin referred to the side effects of the regimen as adverse events in his discussion of the safety of the regimen.}{\i   See}{ Advisory Committee, }{\i supra}{ note 21, at 46-56 (testimony of C. Wayne Bardin, M.D.). }}}{
 related to the pharmacological action of the regimen, most of which were essential for efficacy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 46-47.}}}{  
\par \tab Adverse events, according to a discussion of the results, included painful uterine contractions, nausea, vomiting, diarrhea, headaches, fainting, dizziness, fever, back pain, fatigue and bleeding.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 46-56; Spitz,}{\i  Early Pregnancy Termination, supra}{ note 36, at 1244.}}}{  I
n the French studies, 82% of the women reported painful uterine contractions, 32% of the 82% said such contractions were severe, and 20% of the 82% needed treatment.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See }{Advisory Committee, }{\i supra}{ note 21, at 49-52 (testimony of C. Wayne Bardin, M.D.).  Such treatment included antispadmodics, narcotics, or non-narcotics.  }{\i See id.}}}{
  In the French studies, only 1 to 2% recorded bleeding as a severe adverse event, although 96.6% of the women bled and according to reports, the bleeding was heavier than the woman's heaviest menstrual period 80% of the time.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 53-54.}}}{  The women bled for an average (mean) of 9.1 days.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{ }{\i  See id. }{at 53.}}}{  Despite the reporting of such adverse events, 80% of the women required no pain medication at all to use this regimen.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{ }{\i  See id. }{at 56.}}}{  
\par \tab In contrast, in the United States clinical trial, 68% of the women received at least one medication, usually acetaminophen, for abdominal pain.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  
}{\i See}{ Spitz, }{\i Early Pregnancy Termination}{, }{\i supra }{note 36, at 1244.}}}{  The median duration of bleeding was 13 days in women with duration of gestation of 49 days or less.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 1243.}}}{
  Excessive bleeding necessitated blood transfusions in four women and accounted for many of the hospitalizations, surgical interventions, and administration of intravenous fluids, although only 2% of such in
cidents were reported for women with duration of gestation of 49 days or less.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ }}}{         
\par \tab Apart from the women, there is a concern about the risk to the fetus of administration of mifepristone, in combination with misoprostol.  In the studies discussed abo
ve, the women participating agreed to terminate their pregnancies surgically if medical termination was not successful.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id. }{
at 1246; Advisory Committee, }{\i supra }{note 21, at 32 (testimony of Irving M. Spitz, M.D.).  }}}{  However, not all women returned for their second and third visit}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ Beverly Winikoff, MD et al., }{\i Acceptability and Feasibility of Early Pregnancy Termination by Mifepristone-Misoprostol}{, 7 A}{\scaps rchives}{ F}{\scaps am}{. M}{\scaps ed}{
. 360, 364  (1998) (reporting 5% of women participating in study did not return for third visit)}}}{ and outside a controlled study such behavior is likely to escalate. 
 If a woman does not return, there is a risk she may carry her pregnancy to term.  In this event, is the fetus safe?  Animal toxicology on both mifepristone and misoprostol show teratologic effects in animals, and usually such teratologic effects in anima
ls will translate or have a high possibility of translating to teratologic effects in humans.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Advisory Committee, }{\i supra}{
 note 21, at 34 (testimony of C. Wayne Bardin, M.D.).}}}{  Dr. Bardin, an endocrinologist and independent consultant for the Population Council, reported at a 1996 FDA Advisory Committee meeting, that 21 children have be
en born to women who changed their minds, after mifepristone-misoprostol administration, and three of these children have had congenital anomalies.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{
\i  See id.}{  The congenital anomalies were club foot, abnormal fingernails, and an immune disease that led to death.  }{\i See id. }{at 35.}}}{        
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i C.  Other Medical Uses}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab In addition to its use as an abortifacient, researchers have explored several other potential clinical applications of mifepristone. 
\par \tab Initially, researchers believed mifepristone might have potential as a contraceptive agent or as a post-coital contraceptive after unprotected intercourse.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{, }{\i e.g.}{, Anna Glasier et al., }{\i Mifepristone (RU 486) Compared with High-Dose Estrogen and Progestogen for Emergency Postcoital Contraception}{, 327 N}{\scaps ew}{ E}{\scaps ng}{. J. M}{\scaps ed}{
. 1041 (1992); Lynnete K. Nieman, }{\i The Progesterone Antagonist RU 486: A Potential New Contraceptive Agent (Original Article)}{, 316 N}{\scaps ew}{ E}{\scaps ng}{. J. M}{\scaps ed}{. 187 (1987).}}}{  Many hoped that mifepristone could be 
used as a once a month contraception.  Early studies indicated that the administration of mifepristone during the early luteal phase prevents pregnancy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn 
}{  }{\i See}{ Irving M. Spitz, }{\i Drug Therapy:  Mifepristone (RU 486) - - A Modulator of Progestin and Glucocorticoid Action (Review Article)}{, 329 N}{\scaps ew}{ E}{\scaps ng}{. J. M}{\scaps ed}{. 404 (1993) [hereinafter Spitz, }{\i Drug Therapy}{].
}}}{  However, such a use is impractical, for there is no simple method of detecting the proper time for administration.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See, e.g., id.}}}{
  Although researchers believed that mifepristone could be administered in the late luteal phase to prevent pregnancy, the failure rate of studies, administering mifepristone at such time, ranged from 17 to 19 percent.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See, e.g., id.}}}{  Such a failure rate i
s unacceptably high.   Early studies also indicated that a single dose of mifepristone administered within 72 hours of unprotected sex prevented pregnancy in a high percentage of women.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{, }{\i e.g.}{, Glasier, }{\i supra}{ note 60, at 1041-1044; Marcus G. Plescia, M.D., MPH et al., }{\i Mifepristone (RU 486): Current Knowledge and Future Prospects}{, 7 A}{\scaps 
rchives}{ F}{\scaps am}{. M}{\scaps ed}{. 219, 221(1998).}}}{  Such results brought high hopes that mifepristone could be used as a
 post-coital contraceptive, as well as a once a month contraceptive.  However, as research continued, this method was proven to be impractical as a contraceptive, for monthly administration of mifepristone alters the timing of the subsequent month's cycle
.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g.}{, Plescia, }{\i supra}{ note 64, at 221.}}}{
  An alteration of one's cycle will also inhibit the effectiveness of mifepristone and may be a safety issue for the woman.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{\scaps 
Baulieu}{, }{\i supra}{ note 8, at 26-27.}}}{  These same issues must be addressed before mifepristone can be administered as an occasional post-coital contraceptive.  It is be
lieved that these negative side effects may be avoided by decreasing the dose of mifepristone administered, yet researchers have yet to determine an optimal dose.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   See, e.g., }{Oskari Heikinheimo, M.D. and David F. Archer, M.D., }{\i Mifepristone: A Potential Contraceptive}{, C}{\scaps linical}{ O}{\scaps bstetrics}{ & G}{\scaps ynecology, J}{une }{\scaps 1996,}{ 461, 466.}}}{
  Studies to date have not found an effective, safe, and practical use of mifepristone as a contraceptive or post-coital contraceptive.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{, }{
\i e.g.}{, E.E. Baulieu, }{\i RU 486 (Mifepristone)}{, A}{\scaps nnals}{ N.Y. A}{\scaps cad}{. S}{\scaps ci}{., Sept. 26, 1997, at 47, 53-56 (discussing studies conducted by the end of 1996 regarding use of mifepristone as contraception).}}}{
\par \tab Besides the termination and prevention of pregnancy, researchers have found that mifepristone has other clinical applications within the field of gynecology and obstetrics.  Mifepristone is useful for the preope
rative preparation of women for surgical abortion late in the first trimester.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Spitz, }{\i Drug Therapy}{
, supra note 61; Andre Ulmann et al., }{\i Clinical Uses of Mifepristone (MFP)}{, A}{\scaps nnals}{ N.Y. A}{\scaps cad}{. S}{\scaps ci}{.,  June 12, 1995, at 248, 254 (1995).}}}{
  Pretreatment with mifepristone softens the cervix and reduces the interval between the administration of prostaglandin and the expulsion of the uterine contents.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{, }{\i e.g.}{, Ulmann, }{\i supra}{ note 69, at 254.}}}{  Mifepristone has also been proposed to induce labor after intrauterine fetal death and at the end of the third trimester.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{,}{\i  e.g.}{, Ulmann, }{\i supra}{ note 69, at 252, 256-257; Michael S. Edwards, M.D., }{\i Mifepristone: Cervical Ripening and Induction of Labor}{, C}{\scaps linical }
{O}{\scaps bstetrics}{ & G}{\scaps ynecology, J}{une}{\scaps  1996, }{at}{\scaps  }{469.}}}{  Researchers have also studied the effects of mifepristone administration in women with endometriosis.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{, }{\i e.g.}{, Arlene J. Morales, M.D. et al., }{\i Mifepristone:  Clinical Application in General Gynecology, }{C}{\scaps linical }{O}{\scaps bstetrics}{ & G}{\scaps ynecology, J}{
une }{\scaps 1996,}{ at 451, 453-455; L. Michael Kettel, M.D. et al., }{\i Preliminary Report on the Treatment of Endometriosis with Low-dose Mifepristone (RU 486)}{, 178 A}{\scaps m}{. J. O}{\scaps bstetrics}{ & G}{\scaps ynecology}{ 1151 (1998).}}}{
  Although no change was observed in the extent of the disease, women reported that administration of mifepristone relieved their pelvic pain.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i 
  See, e.g.}{, Morales, }{\i supra }{note 72, at 455.}}}{  
\par \tab Outside the field of gynecology and obstetrics, researchers are hopeful that the progesterone antagonist feature of mifepristone will prove beneficial
 in treating tumors with progesterone receptors.  More specifically, researchers have proposed the use of mifepristone in the treatment of women with certain types of breast cancer, consisting of malignant tumors with progesterone receptors.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{Andre Ulmann et al., }{\i RU 486}{, S}{\scaps cientific}{ A}{\scaps merican}{, June 1990, at 42, 48; Kathryn B. Horwitz, }{\i The Molecular B
iology of RU 486.  Is There a Role for Antiprogestins in the Treatment of Breast Cancer?}{, 13 E}{\scaps ndocrine}{ R}{\scaps ev}{. 146 (1992).}}}{  Limited prel
iminary studies indicate that some women with breast cancer may respond to mifepristone treatment.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See, e.g.}{, Spitz, }{\i Drug Therapy}{, }{\i 
supra }{note 61.  }}}{  The National Cancer Institute of Canada is conducting the first large-scale controlled trial of mifepristone in patients with breast cancer.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See, e.g., }{Oliver Sartor, M.D. and William D. Figg, PharmD, }{\i Mifepristone: Antineoplastic Studies}{, C}{\scaps linical }{O}{\scaps bstetrics}{ & G}{\scaps ynecology}{, June 1996, at 498, 502.}}}{  Researchers 
have also proposed using mifepristone for the treatment of inoperable mengingiomas, benign tumors of the membranes that surround the brain, due to the abundance of progesterone receptors found in such tumors.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{,}{\i  e.g.}{, Jeremy Cherfas and Joseph Palca, }{\i Hormone Antagonist with Broad Potential}{, S}{\scaps ci}{., Sept. 22, 1998, at 1322.}}}{
  Results of preliminary trials indicate that administration of mifepristone may prompt tumor regression.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See, e.g., }{Lou Finter, }{\i 
French Abortion Drug RU 486: U.S. Research Battle Heats Up}{, J. N}{\scaps at'l }{C}{\scaps ancer }{I}{\scaps nst}{., Mar. 6, 1991, at 316; Sartor and Figg, }{\i supra}{ note 76, at 502-503.}}}{ 
\par \tab Finally, in addition to being a progesterone antagonist, mifepristone is a glucocorticoid antagonist.  Mifepristone binds to cortisol receptors and blocks the effect of excess cortisol in the circulation.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See, e.g., }{Plescia, }{\i supra }{note 64, at 222.}}}{
  Therefore, researchers have proposed the use of mifepristone in treatment of Cushing's Syndrome, a condition that results from chronic exposure to excessive glucocorticoids.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{, }{\i e.g.}{, Oliver Sartor, M.D. and Gordon B. Cutler, Jr., M.D., }{\i Mifepristone:  Treatment of Cushing's Syndrome}{, C}{\scaps linical }{O}{\scaps bstetrics }{& G}{\scaps ynecology}{, June 1996, at 506.}
}}{  Preliminary studies suggest that treatment with mifepristone will ameliorate the condition of patients with certain types of Cushing's Syndrome.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  }{\i See, e.g., id. }{(discussing prior clinical studies regarding the treatment of Cushing's Syndrome with mifepristone)}}}{
  Other applications for the antiglucocorticoid effects of mifepristone include the application of eye drops containing mifepristone to lower eyeball pressure in patients with gl
aucoma and the use of mifepristone to treat burns and abrasions by accelerating the healing process.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Cherfas and Palca, }{\i supra }{
note 77.}}}{   \tab \tab           
\par \tab Most of the large-scale clinical trials to date have focused on mifepristone's application as an abortifacient.  However, it is clear that
 mifepristone has potential beyond its use in terminating pregnancy.  Despite researchers' optimism regarding mifepristone's other uses, American researchers have found it difficult to conduct clinical studies within the past decade.  The reasons for this
 difficulty will be explored in Part IV of this paper.
\par }\pard \qc\sl480\slmult0\widctlpar\adjustright {
\par Part II
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab Since the introduction of mifepristone in France, Americans have been choosing sides and drawing battle lines.  On one side stands those opposed to the availability of mifepristone in the Unit
ed States, on the other those who wish to hasten the availability of mifepristone in the United States.  Both, motivated by deep ideological beliefs, have been relentless in their fight to win the battle.    
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i A.  Anti-abortionists}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab Anti-abortionists compri
se the vast majority of those opposed to the availability of mifepristone in the United States.  Their campaign has been spearheaded by the National Right to Life Committee or the NRLC, the Nation's largest pro-life organization, and its fearless leaders,
 
Dr. John Willke, former president, and Dr. Richard Glasow, director of education.  Other pro-life organizations, such as the Life Issues Institute, the Family Research Council, and the American Life League, have joined the NRLC to speak out against the ap
proval of mifepristone in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Advisory Committee, }{\i supra}{
 note 21, at 156, 186, 194 (testimony of American Life League, Family Research Council, and Life Issues Institute).}}}{
  The Catholic Church has also voiced its disapproval of the use of mifepristone as an abortifacient, due to the Catholic Church's stance against abortion.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See, e.g.,}{ Aaron Zitner, }{\i What Ever Happened to the Saga of RU-486?}{, B}{\scaps oston}{ G}{\scaps lobe}{, Nov. 23, 1997, (Magazine), at 18.  An editorial i
n the Vatican newspaper, believed to represent the views of Pope John Paul II, attacked mifepristone as the "pill of Cain: the monster that cynically kills its brothers."  }{\i Id.}}}{
\par \tab Anti-abortionists fear that the introduction of mifepr
istone in the United States may undermine their entire campaign against abortion.  The NRLC often relies on intimidation to convince women to carry their babies to term by showing women pictures of the fetus during pregnancy.  Anti-abortionists fear that 
t
his tactic will no longer be useful if mifepristone can be used to terminate pregnancy at an early stage.  Dr. John Willke of the NRLC voiced his concern saying, "And if what [we] destroy in there doesn't look human, then it will make our job more difficu
lt".}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Megan Rosenfeld, }{\i Conception and Controversy: The French Doctor and his Pill to Prevent Pregnancy}{, W}{\scaps ash. }{P}{\scaps ost}{
, Dec. 18, 1986, at C1.}}}{
  Anti-abortionists use these same pictures of fetuses to picket abortion clinics and stage turbulent demonstrations.  Such tactics will become less effective, if the use of mifepristone diminishes the number of abortion clinics due to the administrati
on of the drug in doctors' offices.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Mindy J. Lees,}{\i  I Want a New Drug:  RU-486 and the Right to Choose}{, 63 S. C}{\scaps al}{. L. R}{
\scaps ev}{. 1113, 1125 (1990).}}}{  Those opposed to abortion are also concerned that the simple taking of a pill, mifepristone, is too easy and the moral significance of abortion will diminish; according to Congressman Robert K. Dornan (R-Cal), "with th
e 'death pill', the taking of a pre-born life will be as easy and as trivial as taking aspirin."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Csilla Muhl, }{\i 
RU-486:  Legal and Policy Issues Confronting the Food and Drug Administration}{, 14 }{\scaps J. Legal Med.}{ 319, 339 (1993).}}}{
  Abortion opponents have characterized mifepristone as ushering in an era of "guilt-free, responsibility-free, carefree living".}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  R. Alta Charo, }{
\i A Political History of RU-486}{, }{\i in }{B}{\scaps io}{-M}{\scaps edical}{ P}{\scaps olitics}{ 43, 48 (Kathi E. Hanna ed., 1991) (quoting D. Andrusko, }{\i The Distortion Factor}{, T}{\scaps he}{ N}{\scaps ational }{R}{\scaps ight to}{ L}{\scaps ife}
{ N}{\scaps ews}{, January 8, 1991, at 4.)}}}{  
\par \tab Although all of the anti-
abortionists fears may not be accurate according to the facts as is discussed later in Section C, abortion opponents may be accurate in their assessment that they will lose support.  Polls show that Americans oppose later abortion at a much greater rate t
han early abortion.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i See}{ E}{\scaps verett}{ C}{\scaps arll }{L}{\scaps add}{ and K}{\scaps arlyn}{ H. B}{\scaps owman}{, }{\scaps 
Public Opinion about Abortion}{ 10, 34 (2d ed. 1999).  In a survey by the Gallup Organization for CNN/USA Today in August of 1996, 64% said that abortion should be generally legal in the first three months of pregnancy
, while 65% said it should be generally illegal in the second three months of pregnancy.  }{\i See id.}{ at 34.}}}{
  Mifepristone, in combination with misoprostol, must be used within the first seven weeks of pregnancy in order to effectively terminate pregnancy.  Therefore, fewer Americans may be opposed to mifepristone as a form of pregnancy termin
ation compared to surgical abortion.
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i B.  Women's Movement}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab Those in favor of a woman's right to choose comprise a vast majority of those fighting to hasten the approval of mifepristone in the United States.  The woman's movement is spearheaded by the Femin
ist Majority Foundation, the FMF, and the Abortion Rights Mobilization, ARM, and their fearless leaders, Eleanor Smeal and Lawrence Lader, respectively.  The FMF is an organization dedicated to achieving political, economic, and social equality for women.
}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Feminist Majority  Foundation and Feminist Majority Chronologies (visited Mar. 27, 2000) <http://www.feminist.org/welcome/index.html>.}}}
{  Lawrence Lader, a 1941 Harvard graduate and former magazine journalist, has fought for the women's right to choose since the early 1960's.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See}{ Zitner, }{\i supra}{ note 84.}}}{  He formed the National Abortion Rights Action League, a premier pro-choice organization, and has gone on to crusa
de for the introduction of mifepristone in the United States; he formed the Abortion Rights Mobilization to do just that.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i id.}}}{
     
\par \tab Pro-choice advocates support the introduction of mifepristone in the United States, because it will provide women with an addit
ional option which advocates believe has many advantages over that of surgical abortion.  First, medical abortion does not involve the risk of surgery, such as injuries to the cervix or uterus, infections, or complications from anesthesia.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See, e.g., }{Gwendolyn Prothro}{\i , RU 486 Examined:  Impact of a New Technology on an Old Controversy,}{ 30}{\scaps  U. Mich. J.L. Ref.}{ 715, 726 (1997)}{
\i . }}}{  Also, it can be used in the earliest weeks following fertilization; many doctors will not perform a surgical abortion until the seventh week of pregnancy, because the failure rate after such time is almost zero.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{   }{\i See}{, }{\i e.g}{., Marge Berer, }{\i "Inducing a Miscarriage":  Women-Centered Perspectives on RU 486/Prostaglandin as an Early Abortion Method}{, }{\scaps 
Law, Medicine, & Health Care}{, Fall 1992, at 199, 200.}}}{  Those who support mifepristone believe that the ability to end a pregnancy immediately may lessen the emotional trauma for the woman.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., id.}{; Zitner, }{\i supra}{ note 84.}}}{  In addition, medical abortion gives more control to the patient.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{, }{\i e.g.}{, Berer, }{\i supra}{ note 94, at 201-202; Sarah Glazer, }{\i Controversy Persists on French Abortion Pill;
 Efforts to Study the Drug for Other Uses Are Stymied in the U.S.}{, W}{\scaps ash. }{P}{\scaps ost}{, Dec. 10, 1991, at Z7. }}}{  "When you give a woman three tablets of RU 486, she's standing up, she is in her clothes, and she can talk. [
With surgical abortion], she is on her back, [and] she has got her feet in stirrups."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization:  Hearing Before the Subcomm. on Regulation, Bus. Opportunities, and Energy of the H.R. Comm. on Small Bus}{
., 102d Cong. 11 (1991) (statement of Dilys Cossey, chairwoman, British Family Planning Association).}}}{  Pro-choice advocates also believe women will view medical abortion as a more natural process, more like an induced miscarriage than an abortion.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{Berer, }{\i supra}{ note 94, at 200.}}}{  
\par \tab Finally, medical ab
ortion supporters are hopeful that mifepristone will move abortions out of the clinics and into doctors' offices and eventually private bedrooms.  This is important to pro-choice advocates for three reasons.  First, as of 1997, surgical abortion was provi
ded in only 16% of U.S. counties.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{Gayle Kirshenbaum, }{\i The Stealth Operation to Market RU-486}{, G}{\scaps eorge}{ M}{\scaps 
agazine}{, April 1997, at 112, 112. }}}{
  It is hoped that the use of medical abortion will make abortion more widely available to women.  A 1995 survey by the Henry J. Kaiser Family Foundation suggests this may be true; the results revealed that more doctors wil
l be willing to offer mifepristone than to perform traditional surgical abortions.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ }{\i id.}}}{
  Second, women's access to clinics that provide abortion is often impeded.  Abortion clinics have become the target of protests and violence.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See}{ }{\i generally }{Eric Schaff, M.D., }{\i Redefining Violence Against Women:  The Campaign of Violence and the Delay of RU486}{, 8 Temp. Pol. & Civ. Rts. L. Rev. 311 (discussing the violence aimed at abortion clinics and their providers).}}}{
  If the violence has not alre
ady prevented the clinic from providing abortion, violence may prevent women from visiting the clinics.  In addition, fear of blockades and violence may prevent doctors from advertising their services, leaving women to rely on mere word of mouth.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Gina Kolata, }{\i Abortion Pill Reaches New U.S. Juncture}{, }{\scaps N.Y. Times}{, July 19, 1996, at A10.}}}{  Third, 
medical abortion in a doctor's office or in one's home would afford women more privacy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{, }{\i e.g.}{, Michelle Lynn Lakomy, }{\i 
A Meaningful Choice:  Two FDA Approved Drugs Are Combined to Perform Medical Abortions}{, 18 }{\scaps Women's Rts. L. Rep.}{ 49, 52 (1996) (discussing the privacy advantages of medical abortion).}}}{
  Women would be able to make a choice without the fear of abortion clinic protesters.  Such an unimpeded choice has the potential to reduce the stigma of abortion for women.
\par \tab A study of the acceptability and feasibility of early pregnancy termination by mifepristone, in combination with misoprostol, confirms that many American women would prefer medical abortion to surgical abortion.  On the third visit of the United St
ates clinical trial discussed in Part I.B, the participants were questioned about their abortion experience.  The results, published in the April 1998 }{\i Archives of Family Medicine}{
, indicate that 95.7% would recommend this medical abortion to others and 91.2% would choose it again.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Winikoff, }{\i supra}{
 note 57, at 360.  See also page 363, which states that 91.8% would choose it again.}}}{  Even among women for whom the method failed, 69.6% stated they would try it again.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid 
{\cs16\super \chftn }{\i   See id.}}}{  The women listed the following as the most positive attributes:  no surgery or injections, noninvasive (45.1%), natural, feminine like menses or
 miscarriage (23.6%), less pain than surgical abortion (19.8%), easier emotionally and less frightening (16.9%), and easier, simpler or faster (9.7%).}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  }{\i See id.}{ at 363-364.}}}{  This study confirmed that pro-choice advocates were correct in assuming women would view medical abortion as an option with potential advantages compared to surgical abortion.
\par \tab Unlike anti-abortionists, those in favor of a women's right to choose have found support from other groups.  Institutions dedicated to issues of reproductive health, such as the Alan
 Guttmacher Institute, and population control, such as the Population Council, have supported and advocated for the approval of mifepristone in the United States.  Members of the medical community have also voiced their support for the introduction of mif
epristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g.}{, Steve L. Heilig, }{\i 
RU 486:  What Physicians Know, Think, and (Might) Do -- A Survey of California Obstetrician/Gynecologists, }{\scaps Law, Medicine, & Health Care}{, Fall 1992, at 184 (indicating that majority of obstetricians/gynec
ologists in California believe mifepristone should be made available for both clinical practice and additional research).}}}{
  The most influential, the American Medical Association, voted to support the legal availability of mifepristone for appropriate research and indicated clinical practices.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid 
{\cs16\super \chftn }{ }{\i  See RU 486: The Import Ban and its Effect on Medical Research:  Hearing Before the Subcomm. on Regulation, Bus. Opportunities, and Energy of the H.R. Comm. on Small Bus.}{
, 101st Cong. 31 (1990) (testimony of P. John Seward M.D., member, board of trustees, American Medical Association).}}}{  Medical researchers have begun a campaign of their own for the availabi
lity of mifepristone in the United States for additional research on other clinical applications of mifepristone.     
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i C.  The Truth behind the Debate}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab In theory, each side may appear to have drawn their battle lines rationally.  However, the reality of th
e abortion pill suggests that it may not revolutionize the abortion debate.  The administration of mifepristone, in combination with misoprostol, for termination of pregnancy requires three office visits.  This type of medical abortion is not performed in
 the privacy of one's own home and is not likely to be performed there for some time, due to distribution restrictions.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ discussion }{\i 
infra}{ Part IV.G.}}}{  Moreover, the treatment may not become available in doctors' offices for quite some time.  Experts believe that clinics that already pr
ovide abortions are likely to remain the major providers, until others gain confidence in the method and feel that they will not be harassed by anti-abortionists, which may be quite some time.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Pertman, }{\i supra }{note 5;  }{\i Main Question about Abortion Pill:  Which Doctors Will Prescribe It?}{, }{\scaps St. Louis Post-Dispatch}{, Sept. 20, 1996, at 1A.}}}{
  Therefore, medical abortion may not be as widely available as advocates hope.  
\par \tab In addition, it isn't as simple and easy as opponents feared.  First, in France, the number of abortions has not increased due to the use of mifepristone, suggesting that it may not trivialize the abortion decision.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Pertman, }{\i supra }{note 5.}}}{  Second, as well as
 requiring three office visits, the method is a gradual process, which can last for several days; during this time, uterine pain and bleeding is common.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn 
}{  }{\i See}{ Spitz, }{\i supra}{ note 36, at 1243-1244.}}}{  According to the President of the original company holding the patent on mifepristone, "[i]t's an appalling psychological ordeal."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\scaps Renate Klien et al}{., }{\scaps RU 486 Misconceptions, Myths and Morals 51 (1991).}}}{
  Some suggest that the gradual process may be a good thing, for it creates an opportunity to dwell on the implications of the pregnancy and abortion and to cope with the conflicting feelings which surface.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Berer, }{\i supra}{ note 94, at 203.}}}{  Others fear that women will view the gradual process, including physical pain, as punishment.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 203; Glazer, }{\i supra}{ note 96.}}}{  Either way, the method is not as simple as popping a pill, physically or emotionally.  
\par \tab Advocates have also praised medical abortion for it allows a women to terminate pregnancy early, but others are concerned that women may have a higher regret rate due to the need for an early decision.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Glazer, }{\i supra}{ note 96.}}}{  Medical abortion is also not a low cost alternative, as some hoped; it is likely to cost the same amount as a surgical abortion.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Kirschenbaum, }{\i supra}{ note 99, at 112 (estimating cost of medical abortion to be about $300); }{\i 
Mifepristone Ancillary Costs Are Being Covered by Seattle Area-Insurers}{, }{\scaps The Pink Sheet}{, Oct. 11, 1999 (stating cost of therapy with mifepristone likely to be equivalent to the cost of surgical abortion).}}}{    Finally
, if abortion, both surgical and medical, remains in the clinics, protests and violent demonstrations are likely to continue if not worsen.  Michael Policar, the national medical director of Planned Parenthood, said, "I don't think anyone should be saying
 RU-486 [mifepristone] is a panacea because, if anything, things may become more polarized and there could be more violence."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Pertman, }{
\i supra}{ note 5.}}}{  The introduction of mifepristone may change the political landscape, but probably only over time.  Some think its greatest contribution will be paving the way for additional research and forms of medical abortion.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i Main Question About Abortion Pill:  Which Doctors Will Prescribe It?}{, }{\i supra}{ note 110.}}}{
  And at the least, pro-choice advocates would argue, it is another option for women.
\par 
\par 
\par }\pard \qc\sl480\slmult0\widctlpar\adjustright {Part III
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab Mifepristone was first synthesized in 1980 by Georges Teutsch, a chemist for the French pharmaceutical company, Roussel-Uclaf.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ B}{\scaps aulieu}{, }{\i supra}{ note 8, at 83.}}}{
  Roussel-Uclaf named the drug RU-486.  Although not originally synthesized for use in termination of pregnancy, Dr. Etienne-Emile Baulieu, a part time consultant to Roussel-Uclaf, knew it had potential
 to interrupt pregnancy when he learned of its antiprogesterone properties.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}{ at 83-84.}}}{
  Dr. Baulieu had his friend, Dr. Walter Herrmann, administer mifepristone to eleven women.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 85.}}}{
  After successful termination in 9 out of 11 women, Dr. Baulieu was encouraged and clinical studies began on a larger scale.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{
 at 85-86.}}}{  In the fall of 1987, Laboratories Roussel, a division of Roussel-Uclaf, applied for a license to market mifepristone alone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See id.}{ at 36.}}}{  In January of 1988, the Ministry of Health demanded more information on the use of a prostaglandin.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id. }{at 38.}}}{
  In March of 1988, Laboratories Roussel provided a new application and in September of 1988, the Ministry of Health officially approved RU-486, or mifepristone, for distribution in France.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id. }{at 38-41.}}}{   
\par \tab By the time of Laboratories Roussel's first applica
tion for approval, controversy over the drug had already begun.  Dr. John Willke, then president of the NRLC, had formed an international federation with headquarters in France and Italy and written letters in July and December of 1987 to the French gover
nment describing the alleged dangers of mifepristone and declaring it "chemical warfare on the unborn".}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}{ at 35.}}}{
  In June of 1987, anti-abortionists held a three-day conference in New Orleans where they strategized on how to resist RU-486.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{
\i supra}{ note 88, at 54.}}}{  Dr. Edouard Sazik, pres
ident of Roussel-Uclaf, began receiving as many as 25 threatening letters a day stating such accusations as "You kill babies and you will suffer the consequences" or "Assassins, stop your work of death."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Steven Greenhouse, }{\i A New Pill, A Fierce Battle}{, }{\scaps N.Y. Times}{, Feb. 12, 1989, \'a76 (Magazine), at 23.}}}{  Such letters even threatened the families of Rouss
el-Uclaf's executives.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{\i supra}{ note 88, at 46.}}}{
  On June 22, 1988, the eve of Roussel-Uclaf's annual meeting, the NRLC released a letter it sent to the French government protesting its involvement, through ownership of 40% of the stock of Roussel-Uclaf, with RU-486.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i National Right to Life Urges French Government}{, PR Newswire, June 22, 1988.  }{\i See also}{ }{\scaps Baulieu}{, }{\i supra}{
 note 8, at  50 (indicating French government owns a third of Roussel-Uclaf); Alan Riding, }{\i Abortion Politics Are Said to Hinder Use of French Pill}{, }{\scaps N.Y. Times}{, July 29, 1990, \'a7
1, at 1 (indicating French government owns 36% of Roussel-Uclaf).}}}{  The next day, hundreds of abortion opponents protested in front of Roussel-Uclaf's headquarters during the company meeting.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ }{\i Greenhouse}{, }{\i supra}{ note 129.}}}{
\par \tab Roussel-Uclaf and Dr. Sazik, himself, felt the pressure.  Company directors contemplated withdrawing the application, before approval, but decided against such a move.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid 
{\cs16\super \chftn }{  }{\i See}{ B}{\scaps aulieu}{, }{\i supra}{ note 8, at 40.}}}{  Instead, the company planned to demur for commercial reasons when it was time to market the drug.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{  In addition to anti-abortionists, Dr. Sazik was feeling pressure from within the company.  
\par \tab Hoechst A.G., a leading German pharmaceutical firm, owned 54% of Roussel-Uclaf stock at this time.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See }{Riding,}{\i  supra }{note 131; }{\i 
The Safety and Effectiveness of the Abortifacient RU 486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{,}{\i  supra}{ note 97, at 18 (testimony of Dr. Etienne-Emile Baulieu).  As of 1997, Hoechst A.G. 
owned all of Roussel-Uclaf stock.  }{\i See}{ Zitner, }{\i supra}{ note 84.}}}{  Hoechst traces its corporate history to I.G. Farben, the manufacturer of Zyklon-B, which was used in the gas chambers of Auschwitz.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i  See, e.g.}{, Zitner,}{\i  supra}{ note 84.}}}{  Zyklon-B has been called the "human pesticide", and anti-abortionists have used the same name for mifepristone.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   Id.}}}{
  During the company's annual meeting on June 23, 1988, protesters dressed as World War II deportees and shouted, "You are turning the uterus into a crematory oven".}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  B}{\scaps aulieu}{, }{\i supra}{ note 8, at 38-39.}}}{  Hoechst feared such taunts; they did not want to be credited with "doing to fetuses what the Nazis had done to the Jews".}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Greenhouse, }{\i supra}{ note 129.}}}{
  Hoechst, also, feared boycotts.  The NRLC had already stated its intent to boycott any pharmaceutical company that attempted to manufacture or market mifepristone in the United States.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Richard D. Glasow (editorial), }{\i Doubts Remain on Abortion Pill's Safety}{, }{\scaps N.Y. Times}{, Apr. 23, 1988, \'a71, at 30.}}}{
  Finally, Wolfgang Higler, the company's chief executive officer, is a devout Roman Catholic; he stated that "an abortion pill violates the company's credo to support life."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  Greenhouse, }{\i supra}{ note 129.}}}{
\par \tab Turmoil could also be felt within Roussel-Uclaf.  Roussel-Uclaf is a family founded French company, where many employees still see themselves as part of a family.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ }{\scaps Baulieu}{, }{\i supra}{ note 8, at 107.}}}{  According to Dr. Baulieu in such an atmosphere "certain things are simply not done"; "Fears of a boycott are one thing. Worse are fears of a stain on the family name."
}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   Id.}{ at 108.}}}{
  Roussel-Uclaf had proven itself susceptible to public opinion before.  In the 1960's, Roussel-Uclaf had decided not to pursue production of the contraceptive pill, because it feared a public and religious backlash.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Charo, }{\i supra}{ note 88, at 58.}}}{
\par \tab Despite Dr. Sazik's unwillingness to repeat the company's mistake and his own inner struggle between the advancement of science and protecting a company, Dr. Sazik voted to withdraw RU-486 from the French market on October 21, 1988.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Greenhouse, }{\i supra}{ note 129.}}}{  An inter-office memorandum cited publi
c emotion and the polemic incited by the possibility of using the drug for abortion as reasons for suspending the distribution of the drug.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ 
}{\scaps Baulieu}{, }{\i supra}{ note 8, at 43.}}}{  On October 26, 1988, Roussel-Uclaf informed the press that it was pulling RU-486 off the market.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  }{\i See}{ Charo, }{\i supra}{ note 88, at 61.}}}{  On the same day
, 10,000 researchers and physicians were gathered in Rio de Janiero for the World Congress of Gynecology and Obstetrics; Roussel-Uclaf's announcement turned the meeting into a strategy session on how to rescue the drug.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id. }{at 63.}}}{
\par \tab Roussel-Uclaf's suspension did not last long.  Roussel-Uclaf issued a statement on October 28, 1988 agreeing to put the drug back on the market.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  }{\i See}{ Charo, }{\i supra}{ note 88, at 65-66.}}}{  Such an announcement was made only after Health Minister Claude Evin told Roussel-Uclaf that the government would use its status as partial own
er of Roussel-Uclaf and some special provisions of French law to transfer the patent to another company in order to serve the public good.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See id. }{ 1968 law holds that if a company refuses to make a drug available, the health minister can withdraw the license and award it to another company.  }{\i See}{ }{\scaps Baulieu}{, }{\i supra}{ note 8, at 50.}}}{
  The Health Minister is said to have been motivated by a fear that the anti-abortion movement, after their triumph in keeping RU-486 off the market, would begin fighting for a repeal of the 1975 French law legalizing abortion,}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Charo, }{\i supra}{ note 88, at 65.}}}{
  In explaining his decision to the public, he said, "I could not permit the abortion debate to deprive women of a product that represents medica
l progress.  From the moment, Government approval for the drug was granted, RU-486 became the moral property of women, not just the property of the drug company."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   }{Greenhouse, }{\i supra}{ note 129.  }}}{  Roussel-Uclaf was, undoubtedly, pleased by the government order, for it relieved the compan
y of the moral burden and shifted responsibility to the government.  However, many opponents believe that the move was orchestrated by Dr. Sazik and the Health Minister to shift the blame.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See }{Charo,}{\i  supra }{note 88}{\i , }{at 66-67}{\i .}}}{  Specifically, anti-abortion groups believed it was a charade and vowed to hold both Roussel-Uclaf and Hoechst responsible.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}{ at 67.}}}{ 
\par \tab RU-486, or mifepristone, was now available in France, but availability of the drug, in the near future, did not look hopeful for markets abroad.  Hoechst instructed Roussel-Uclaf that RU-486 was 
going nowhere beyond the French borders until it proved itself at home.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{\scaps Baulieu}{, }{\i supra}{ note 8, at 105.}}}{
  Roussel-Uclaf decided to keep RU-486 in France.  However, in the event that RU-486 would be exported for use as an abortifacient, the company developed a set of conditions that the i
mporting country would have to satisfy.  First, abortion must be legal in the country.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 109; }{\i 
The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers:  Hearing Before the Subcomm. on Regulation, Bus. Opportunities, and Energy of the H.R. Comm. on Small Bus.}{
, 102d Cong. 76 (1992) (letter from Dr. Sazik, President of Roussel-Uclaf to Doctor E.H. Drew of the Hoechst Celanese Corporation).}}}{  Two, abortion must be accepted widely by public opinion.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See }{\scaps Baulieu}{\i , supra}{ note 8, at 109}{\i ; The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{,}{\i  supra}{
 note 156, at 76 (letter from Dr. Sazik, President of Roussel-Uclaf to Doctor E.H. Drew of the Hoechst Celanese Corporation).}}}{  Third, a suitable prostaglandin must be available in the country.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{\scaps Baulieu}{\i , supra}{ note 8, at 109}{\i ; The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{,}{\i  supra}{
 note 156, at 76 (letter from Dr. Sazik, President of Roussel-Uclaf to Doctor E.H. Drew of the Hoechst Celanese Corporation).}}}{  Fourth, distribution of the drug must be under tight official control, as with narcotics.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{\scaps Baulieu}{\i , supra}{ note 8, at 109}{\i ; The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{,}{\i 
 supra}{ note 156, at 76 (letter from Dr. Sazik, President of Roussel-Uclaf to Doctor E.H. Drew of the Hoechst Celanese Corporation).}}}{  Fifth, patients must sign a letter agreeing to a surgical abortion if the pill failed.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{\scaps Baulieu}{\i , supra}{ note 8, at 109}{\i 
; The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{,}{\i  supra}{ note 156, at 76 (letter from Dr. Sazik, President of Roussel-Uclaf to Doctor E.H. Drew of the Hoechst Celanese Corporation).}
}}{  Dr.  Baulieu insists that there was a sixth condition; the company would not sanction exports unless ranking government officials in the country urged them to do it.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See }{\scaps Baulieu}{\i , supra}{ note 8, at 109}{\i .}}}{
  Roussel-Uclaf, in a letter submitted at a 1992 congressional hearing, confirmed Dr. Baulieu's suspicion concerning Roussel-Uclaf's position regarding the export of mifepristone to other countries.  Rouss
el-Uclaf indicated there must be an actual wish for the licensing of mifepristone in a particular country.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{, }{\i supra}{ note 156}{\i , }{
at 76 (letter from Dr. Sazik, President of Roussel-Uclaf to Doctor E.H. Drew of the Hoechst Celanese Corporation).}}}{
  The letter indicated such a wish could come in the form of a written request from a representative, competent body such as the government or health authorities.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}}}{
\par 
\par 
\par 
\par 
\par }\pard \qc\sl480\slmult0\widctlpar\adjustright {Part IV
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\i A.  FDA Approval Process}{
\par \tab Regardless of Roussel-Uclaf's exporting policy, according to the Federal Food, Drug, and Cosmetic Act, mifepristone cannot be imported into the United States and introduced into interstate commerce until the drug is approved by the FDA.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 21 U.S.C.A. \'a7 355(a) (West Supp. 1999); 21 U.S.C.A. \'a7 381 (West Supp. 1999).}}}{
  Before the FDA will approve a new drug, a sponsor must apply for approval by submitting a new drug application, an NDA.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 21 U.S.C.A. \'a7
 355(b) (West Supp. 1999).}}}{  The NDA must provide sufficient information, for the FDA to determine "whether the drug is safe and effective for its proposed use(s) and whether the benefits of the drug outweigh its risks."}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Center for Drug Evaluation and Research, }{\i CDER Handbook}{ (last modified Mar. 16, 1998) <http://fda.gov/cder/handbook/index.htm> [hereinafter }{\i CDER Handbook}{].  }{\i See}{
 21 U.S.C.A \'a7 355(d) (West Supp. 1999); 21 C.F.R. \'a7 314.50 (1999) (specifying the information which must be included in an NDA).}}}{
  In addition, the FDA will evaluate the proposed labeling and manufacturing of the drug to determine "whether the drug's proposed labeling is appropriate, and, i
f not, what the drug's labeling should contain" and "whether the methods used in manufacturing the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i CDER Handbook}{, }{\i supra}{ note 166; 21 U.S.C.A. \'a7 355 (b).}}}{  
\par \tab The FDA will review the NDA within 180 days and send the sponsor an approval letter, an approvable letter, or a not approvable letter.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}
{ 21 U.S.C.A. \'a7 355(c) (West Supp. 1999); 21 C.F.R. \'a7 314.100 (West Supp. 1999).}}}{  The FDA and sponsor may mutually agree to extend the review period, and they often do.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 21 C.F.R. \'a7 314.100. }}}{  The average approval time for a new drug is approximately two years, although drugs that f
eature an active ingredient not yet marketed in the United States and that represent an important therapeutic gain are given first priority in evaluation and approval.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See }{Karen F. Richards, }{\i RU 486:  A Promising Birth Control Device Entangled in the Abortion Debate}{, }{\scaps 6 J. Pharmacy & L}{. 117, 122.}}}{
  The FDA will send the sponsor an approvable letter if the agency believes that the NDA
 substantially meets the necessary requirements and that it can approve the application if specific additional information is submitted or specific conditions are agreed to by the applicant.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 21 C.F.R. \'a7 314.110 (West Supp. 1999).}}}{  As a practical matter, an approvable letter "serves as a mechan
ism for resolving outstanding issues on drugs that are about to be approved and marketed."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  21 C.F.R. \'a7 314.110.}}}{
  An approvable letter often requires changes in the labeling and may request a commitment to do post-approval studies.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i CDER Handbook
}{, }{\i supra}{ note 166.}}}{
\par \tab Prior to submission of an NDA, the sponsor 
must conduct clinical trials to evaluate the safety and effectiveness of the new drug for its intended purpose.  The FDA may approve the introduction of a drug into interstate commerce "solely for investigational use by experts qualified by scientific tra
ining and experience to investigate the safety and effectiveness" of a new drug.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  21 U.S.C.A. \'a7 355(i) (West Supp. 1999).}}}{
  In order to receive approval to conduct a clinical investigation of a new drug, a sponsor must submit an investigational new drug application, an IND, to the FDA.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{ }{\i  See}{ 21 C.F.R. \'a7 312.20 (1999).}}}{  The IND m
ust include pharmacology and toxicology information regarding the drug, from which the FDA can conclude that the drug is reasonably safe to conduct the proposed clinical investigation.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{\i   See}{ 21 C.F.R. \'a7 312.23(a) (1999).}}}{  Such information is gathered through in vitro and in vivo laboratory animal testing.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   See CDER Handbook}{,}{\i  supra }{note 166.}}}{
  An IND is usually submitted for three phases of testing on a new drug.  Phase I, the initial introduction of the new drug into humans, is "designed to determine the metabolism and pharmacological action of the drug in humans, the side eff
ects associated with increasing doses, and if possible, to gain early evidence of effectiveness."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  21 C.F.R. \'a7 312.21(a)(1) (1999).}}}{
  Phase 2 is conducted to evaluate the effectiveness of the drug for a particular use or treatment and to determine the common short term side effects and risks associated with the drug.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 21 C.F.R. \'a7 312.21(b) (1999).}}}{
  Phase 3 is "intended to gather additional information about effectiveness and safety that is needed to evaluate the over-all benefit-risk relationship of the drug and to provide an adequate basis for physician labeling."}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  21 C.F.R \'a7 312.21(c) (1999).}}}{
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i B.  Early Clinical Investigations in the United States}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab 
Although mifepristone has not received FDA approval for marketing and distribution as a new drug, the FDA has approved clinical testing of the drug in the United States under IND permits.  In 1982, Rouss
el-Uclaf entered an agreement with the Population Council in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i The Safety and Ef
fectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{,}{\i  supra}{ note 97, at 85 (staff memorandum); }{\scaps Baulieu}{, }{\i supra}{ note 8, at 30.}}}{
  The Population Council  is a non-profit research institution dedicated to exploring the causes and consequences of population growth and to improving women's and men's reproductive health.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Advisory Committee, }{\i supra}{ note 21, at 10 (testimony of Sandra P. Arnold).}}}{
  The Population Council, having developed new forms of contraception such as several types of IUDs, has been a major player in the field of reproductive health for over 45 years.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Zitner, }{\i supra}{ note 84.}}}{  The agreement gave the Council rights to import mifepristone into the United States for large-scale testing.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{,}{\i  supra}{
 note 97, at 85 (staff memorandum); }{\scaps Baulieu}{, }{\i supra}{ note 8, at 30.}}}{  In 1983, the Population Council obtained an IND to investigate the use of mifepristone as an abortifacient.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See The Safety and Effectiveness of the Abortifacient RU 486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{ note 97, at 85 (staff memorandum).}
}}{  The Population Council imported the drug under the agreement it had signed with Roussel-Uclaf and testing began at the University of Southern California School of Medicine in 1984.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}{ at 25 (testimony of David Grimes, professor of obstetrics and gynecology and preventive medicine, University of Southern California School of Medicine).}}}{
  Dr. David Grimes, a professor of obstetrics and gynecology at the school, conducted studies from 1984 to 1990 to determine the safety and efficacy of mifepristone for 
early abortion; in one study, Dr. Grimes reported a 90% success rate after administration of 600 milligrams of mifepristone alone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{

\par \tab The FDA has issued IND permits to investigate other clinical applications of mifepristone, as well.  Beginning in 1983, Dr.
 George P. Chrousos performed research at the National Institute of Health on the therapeutic use of mifepristone in a subgroup of patients with Cushing's Syndrome.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ }{\i RU 486:  The Import Ban and Its Effect on Medical Research:  Hearing Before the Subcomm. on Regulation, Bus. Opportunities, and Energy of the H.R. Comm. on Small Bus.}{, }{\i supra}{
 note 108 (testimony of George P. Chrousos M.D., senior investigator and section chief, Pediatric Endocrinology, National Institute of Child Health and Human Development, National Institutes of Health).}}}{
  Dr. Stephen Grunberg at the University of Southern California Medical Center has performed trials for treatment of meningioma with mifepristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{
\i See The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{, }{\i supra}{
 note 156, at 125 (FDA listing of active investigational new drug projects and level of activity within each of 13 multipatient trials).}}}{
  Beginning in 1983, the NIH and the Population Council have conducted research regarding the use of mifepristone as a contraceptive agent.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See id.}{; }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{, }{\i supra}{
 note 108, at 11 (testimony of Lynnette K. Nieman, M.D., National Institute of Child Health and Human Development, National Institute of Health).  Under federal law, the NIH cannot conduct research regarding the use of mifepristone as an abortifacient.  }
{\i See}{ }{\scaps Raymond Tatalovich}{, }{\scaps The Politics of Abortion in the United States and Canada 97}{ (1997).}}}{  Other medical researchers have conducted investigations re
garding the use of mifepristone to treat such diseases as breast cancer and endometriosis.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{, }{\i supra}{
 note 156, at 125 (FDA listing of active investigational new drug projects and level of activity within each of 13 multipatient trials).}}}{  
\par \tab In the late eighties, the FDA issued special permission to ten research groups to use the drug in clinical investigations, yet most of these projects have been discontinued.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{; }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{, }{\i supra}{ note 108, at 56 (subcommittee staff memorandum).}}}{
  The Population Council stopped supporting the clinical trials of mifepristone as an abortifacient at the University of South Carolina in 1987.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  The Population Council paid for only three years of the study.  }{\i See}{ }{\scaps Baulieu}{, }{\i supra}{ note 8, at 140; Gina Kolata, }{\i Boycott Threat Blocking Sale of Abortion-Inducing Drug}{, }{\scaps N.Y. Times}{
, Feb. 22, 1988, at A1 [hereinafter Kolata, }{\i Boycott Threat}{].}}}{  Although research did continue, the study was abruptly stopped in February of 1990.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{\i   See The Safety and Effectiveness of the Abortifacient RU 486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{ note 97, at 85 (staff memorandum); }{\scaps Baulieu}{, }{\i supra}{ note 8, at 140.}}}{
  The supply of mifepristone had run out and Roussel-Uclaf refused to provide more.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., The Safety and Effectiveness
 of the Abortifacient RU 486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{ note 97, at 85 (staff memorandum).}}}{
  Dr. Chrousos testified at a November 19, 1990 congressional hearing, regarding the importation of mifepristone, that his supply of the drug had been depleted and that Roussel-Uclaf refused to make any commitment to supply additional quantities.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, at 18 (testimony of George 
P. Chrousos M.D., senior investigator and section chief, Pediatric Endocrinology, National Institute of Child Health and Human Development, National Institutes of Health).}}}{
  Dr. William Regelson, a professor of medicine at the Medical College of Virginia, testified at the same hearing that after an initial meeting, Roussel-Uclaf refused to meet to discuss supplying the drug for clinical studies regarding Cushing's Syndrome.
}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, a
t 4-6 (testimony of William Regelson, M.D., professor of medicine, Medical College of Virginia).}}}{  Dr. Andre Ulmann, medical director for Roussel-Uclaf, said only that the company did not give them the drug because "our policy is undefined".}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   }{Philip J. Hilts, }{\i F.D.A. Says It Allows Study of Abortion Drug}{, }{\scaps N.Y. Times}{, Nov. 20, 1990, at C9.}}}{ 
\par \tab The question is why, after initial agreement 
in the early eighties to supply the drug to the United States for testing, Roussel-Uclaf adamantly refused in the late eighties to further supply the drug to United States medical researchers, let alone sponsor the drug for approval as an abortifacient.

\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i C.  The Import Alert}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab The Food, Drug, and Cosmetic Act prohibits the importation of drugs not approved for use in this country.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{\i   See}{ 21 U.S.C.A. \'a7 381 (West Supp. 1999);  }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, at 48 (Sandra Barnes, Office of General Counsel of FDA).}}}{
  However, the FDA Regulatory Procedures Manual has stated, since 1977, that the FDA will not detain unapproved new drugs imported for personal use.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }
{\i  See}{ }{\scaps Peter Barton Hutt and Richard A. Merrill, Food and Drug Law:  Cases and Materials}{ 561 (2nd ed. 1996).}}}{
  In July of 1988, the FDA issued further guidance regarding its mail importation policy, entitled "Pilot Guidance for Release of Mail Importations", which outlined the circumstances under which individuals could import unapproved drugs for personal use.}
{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{, }{\i supra}{
 note 108, at 162-164 (Pilot Guidance for Release of Mail Importations).}}}{  Such guidance was meant to address the predicament of cancer and AIDS patients who, in growing number, sought to import unapproved drugs by mail.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Michael J. Brooks, }{\i RU-486: Politics of Abortion and Science}{, 2 J. P}{\scaps harmacy }{& L. 261, 277 (1994); }{\i RU 486:  The Import Ban and Its Eff
ect on Medical Research}{,}{\i  supra }{
note 108, at 48 (testimony of  Sandra Barnes, Office of General Counsel of FDA) (stating "In certain situations, in very limited situations, FDA will occasionally allow in a drug for certain serious and life-threatening condi
tions where an alternative does not exist.").}}}{    Forty drugs were initially excluded from the exception, but mifepristone was not.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Debora C. Fliegelman, }{\i The FDA and RU 486:  Are Politics Compatible with the FDA's Mandate of Protecting Public Health and Safety?}{, 66 }{\scaps Temp. L. Rev}{. 143, 149 (1993).}}}{  On
 September 26, 1988, the FDA issued an Import Bulletin excluding mifepristone from the Pilot Guidance.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  On February 1, 1989, a formal revision of the FDA's Regulatory Procedures Manual occurred; under the new revision known as the "personal use exception"
, importation for personal use of any drug not listed in an import alert was subject to a case-by-case discretionary decision by the FDA.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{
 Brooks, }{\i supra}{ note 202, at 278.}}}{
\par \tab The Regulatory Procedures Manual instructed that the following criteria were to be evaluated to determine whether the FDA should allow importation of the unapproved drug:   
\par \tab 1.  The drug must be for an individual patient.
\par \tab 2.  There must be a small quantity of the drug, a 3 month supply or less.
\par \tab 3.  The drug must be intended to treat a condition of serious nature.
\par \tab 4.  No other treatment must be commercially available in this country.
\par \tab 5.  There must be no known promotion or commercialization of the product.
\par \tab 6.  The product must not pose an unreasonable safety risk to the patient.
\par \tab 7.  The patient must confirm that the product is for his or her personal use and provide \tab the name and address of a practicing physician who will be responsible for his or her \tab treatment.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, at 171-172 (Regulatory Procedures Manual).}}}{
\par \tab At the time of the revision, mifepristone was not the subject of an import alert, only an import bulle
tin.  Therefore, theoretically, the drug could be imported under the personal use exception, if the drug met the above criteria.  On May 5, 1989, eleven members of Congress sent a letter to then FDA Commissioner Frank Young requesting a clarification of t
he FDA's policy regarding the importation of mifepristone and strongly encouraging a ban of the drug.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id. }{
at 183 (letter to Dr. Frank Young from eleven members of congress).}}}{  On May 23, 1989, the agency's Import Operations Branch issued a recommendation that mifepristone was not intended to qualify for the personal use exception.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Fliegelman, }{\i supra}{ note 203, at 149.}}}{
  On June 6, 1989, the FDA issued Import Alert 66-47, concluding that mifepristone is not appropriate for release under the personal importation policy because the "intended use of such [a] drug[s] could pose a risk to the safety of the user."}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   Import Alert IA6647 }{(visited Jan 18, 1999) <http://www/fda.gov/ora/flars/ora_import_ia6647.html>; }{\i 
RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, at 165-166.  Under the Import Alert, if the drug is observed coming into th
is country either in the mail or on someone's person, it is subject to detention by officials of the FDA and the U.S. Customs Service. }{\i  See}{ }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{
, at 35 (testimony of Ronald Chesemore, Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration).}}}{  In a l
etter to Senator Jesse Helms, dated June 9, 1989, FDA Commissioner Young stated that mifepristone is not appropriate for personal importation because "the intended use of this drug makes it likely it would be used without benefit of supervision of a physi
cian and indiscriminate or unsupervised use could be hazardous to the patient's health."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
RU 486:  The Import Ban and Its Effect on Medical Research}{, }{\i supra }{note 108, at 181 (letter from Dr. Frank Young to Senator Helms).}}}{
\par \tab On November 19, 1990, a hearing before the Subcommittee on Regulation, Business Opportunities, and Energy of the Committee on Small Business examined the import ban of mifepristone and its effect on medical research.  
\par \tab Congressman Ron Wyden (D-Ore.), chairman of the subcommittee, accused the FDA of "arbitrary, political, and unscientific RU 486 policies".}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i 
 Id.}{ at 2 (testimony of Chairman Ron Wyden ).}}}{  He questioned the FDA's issuance of an import alert with no e
vidence of an active black market in the drug, no record of any attempts to import the drug into the United States, and no record of any injuries due to the drug.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id. }{at 2,37-44  (testimony of Chairman Ron Wyden).}}}{  Mr. Wyden also remarked on the mere 19 days that elapsed between the congressional demand o
n the FDA to review the importation policy of mifepristone and the FDA's issuance of Import Alert 66-47.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{
at 2, 44-46  (testimony of Chairman Ron Wyden) .}}}{  He called it a "new land speed record for an agency response to congressional inquiries."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
Id. }{at 2  (testimony of Chairman Ron Wyden).}}}{  Ronald Chesemore, Associate Commissioner of Regulatory Af
fairs at the FDA, conceded that the FDA had no concrete evidence of a black market and no evidence of surreptitious entry of mifepristone into the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}{ at 37 (testimony of Ronald Chesemore, Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration).}}}{
  Mr. Chesemore indicated that the FDA was concerned that the publicity of the drug may create a demand for the drug leading to unsupervised distribution.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{\i   See id.}{ at  40-41 (testimony of Ronald Chesemore, Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration).}}}{
  However, Mr. Chesemore and Dr. Solomon Sobel, director of the FDA's Division of Metabolism and Endocrine Disorders, agreed that there was no evidence to doubt Roussel-Uclaf's strict control of the drug in France.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id. }{at  37, 46-47 (testimony of Ronald Chesemore, Associate Commissioner for Reg
ulatory Affairs, U.S. Food and Drug Administration and Solomon Sobel, M.D., Director, Division of Metabolism and Endocrine Drug Products)  Mifepristone is under the same strict controls in France as surgical abortion. Only authorized centers are allowed t
o purchase mifepristone; pharmacies must account for every box and supply doctors only the exact amount needed. }{\scaps  }{\i\scaps S}{\i ee}{ }{\scaps Baulieu}{, }{\i supra}{ note 8, at 85.}}}{
  Mr. Chesemore summed up the agency's position with his statement "We certainly just felt like the personal importation of this drug was serious."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i 
  RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, at 43 (testimony of Ronald Chesemore, Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration)}}}{
   The FDA representatives fell back on the fact that mifepristone does not fit within the personal use exception itself, since it does not treat a life-threatening condition and there is an alternative treatment available.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}{ at 42 (testimony of Sandra Barnes, Office of General Counsel of FDA).}}}{
  Mr. Wyden was not satisfied with this response; he wanted to know why mifepristone was singled out, for the FDA does not usually ban a drug merely because it is unapproved, but allows the personal use exception to dictate.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id}{ at 50 (testimony of Chairman Ron Wyden); Fliegelman, }{\i supra}{ note 203, at 158.}}}{
 In Mr. Wyden's estimation, the FDA should not have made this pro-active move; the import alert was a "non-issue".}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i 
  RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, at 50 (testimony of Chairman Ron Wyden).}}}{ Mr. Wyden contended that the FDA's 
decision was politically motivated, as evidenced by the timing and character of the correspondence between FDA officials and anti-abortion activists.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  }{\i See id.}{ at 2  (testimony of Chairman Ron Wyden).  See also, }{\i Benten v. Kessler}{, 799 F.Supp. 281, 286 (E.D.N.Y. 1992), in which Judge Sifton accuses the FDA of basing its decision on political considerations.}}}{
\par \tab More importantly, Congressman Wyden was concerned about the consequences of the FDA's action.  Mr. Wyden
 contended that the import alert influenced Roussel-Uclaf's decision regarding seeking approval of mifepristone in the United States and providing sufficient quantities for research purposes.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 2-3 (testimony of Chairman Ron Wyden)}}}{  As discussed in Part IV.B, researchers at the hearing testifie
d regarding Roussel-Uclaf's reluctance to supply the drug for research purposes.  Dr. Regelson testified that Roussel-Uclaf may be using the import alert to mobilize people who want the drug; he insisted by withholding the drug from medical researchers an
d people who need the drug, Roussel-Uclaf may have been attempting to force such individuals to create political pressure to balance the threat of boycotts by anti-abortionists.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i  supra }{note 108, at 4-6 (testimony of William Regelson, M.D., professor of medicine, Medical College of Virginia).  }{\i See also}{
 discussion }{\i infra}{ Part IV.D regarding boycott threats.}}}{
\par \tab Congressman Wyden chaired yet another congressional hearing, on July 28, 1992
, focusing on the impact of the import alert of mifepristone on medical research and new drug development.  Almost two years later little had changed.  Mr. Wyden was disappointed, if not angry, to report that Roussel-Uclaf decided to go forward with impor
tant new breast cancer trials in Canada, although many United States institutions wished to conduct the studies.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i 
 See The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{, }{\i supra}{ note 156, at 2 (testimony of Chairman Ron Wyden).}}}{
  The committee heard testimony from David Grow, a man with recurrent meningioma, in which he recounted his difficulties in obtaining mifepristo
ne from Roussel-Uclaf to treat his condition.  Roussel-Uclaf told him that he could arrange a compassionate use exemption from the import alert through the FDA; the FDA told him he could not receive a compassionate use exemption without a written guarante
e of supply from the company, which Roussel-Uclaf would not provide without an IND.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i 
  See The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{, }{\i supra}{ note 156, at 12-15 (testimony of David J. Grow). }}}{
  Congressman Wyden insisted that Roussel-Uclaf was being sent a clear message: "Don't try applying for a general drug approval for RU 486 in this count[sic]y; you won't get a fair shake."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}{ at 2 (testimony of Chairman Ron Wyden).}}}{
  Dr. Marjorie Braude, from the American Medical Women's Association, testified that during discussions with the Roussel-Uclaf research staff, the staff indicated that the import alert was one of the factors which led to their determination
 that the United States does not fulfill the necessary criteria for exportation of the drug.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{
 at 17-19 (testimony of Marjorie Braude, M.D., chairperson, Governmental Affairs Committee, American Medical Women's Association).}}}{
  In fact, Dr. Braude stated that one of the Roussel-Uclaf representatives said that the import alert "has a chilling effect because this drug is differently singled out."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   Id. }{at 25 (testimony of Marjorie Braude, M.D., chairperson, Governmental Affairs Committee, American Medical Women's Association).}}}{
\par \tab The FDA may have been genuinely concerned about safety.  As discussed previously, mifepristone is not safe for unsupervised use.  Moreover, American physicians have not received the necessary training to supervise administration of mifepristone 
for medical abortion.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{   }{\i 
See The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{ note 97, at 7 (testimony of Dr. Etienne-Emile Baulieu).}}}{
  Even Dr. Baulieu, who believes that the entry of mifepristone into the United States depends entirely on the abortion issue, said at a 1991 congressional hearing that the FDA "behaved very rightly."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}{ at 6.  }}}{  At that time, he believed that the individual use of mifepristone to interrupt pregnancy was not reasonable and could be medically dangerous.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 6-7.}}}{
  In addition, Import Alert 66-47 remains in effect today.  The FDA did not change its position, even after President Clinton ordered the Department of Health and Human Services and the FDA to review the import alert of mifepristone.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ discussion }{\i infra }{Part IV.F.}}}{
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\tab Regardless, the evidence suggests that the import alert influenced Roussel-Uclaf's decision not to supply mifepristone to American researchers and women.  Roussel-Uc
laf believed the FDA to be singling out mifepristone, and it perceived such action to signify the power of the political climate in the United States regarding abortion.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  In fact, the FDA did single out mifepristone, although it may have been forced to take such action by inquiries from both congress members and Customs.  }{\i See RU 486:  The Import Ban and Its Effect on Medical Research}{,}{\i 
 supra }{note 108, at 42-43 (testimony of Ronald Chesemore, Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration).  }}}{  
\par }{\i D.  Boycott Threats and Economic Concerns}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab Roussel-Uclaf and its majority sharehold
er feared such power, especially when exerted in the form of threatened boycotts.  Since 1988 the NRLC and other anti-abortion groups, including pro-life hospitals, have threatened to boycott any company that attempts to manufacture or market the abortion
 pill in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kolata, }{\i Boycott Threat}{, }{\i supra}{ note 193; Glasow, }{\i supra}{ note 140; Seelye, }{\i 
Accord Opens Way}{, }{\i supra}{ note 5; Joseph Schuman, }{\i Fearing U.S. Boycotts, Hoechst Gives Away World Rights to Abortion Pill}{, Associated Press, Apr. 8, 1997.}}}{
  Dr. Glasow of the NRLC has also said that the NRLC will organize a boycott, despite the primary use of the drug, unless the drug is the only one available to treat a life-threatening condition.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kolata, }{\i Boycott Threat}{, }{\i supra}{ note 193.}}}{  In late 1988, the RCR Alliance 
registered with Congress as lobbyists and then sent the Hoechst chairman an outline of its three pronged strategy, including a boycott of any United States financial firm that was holding Hoechst stock in its international funds.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Charo, }{\i supra}{ note 88, at 69.}}}{  In mid-March of 1989, th
e International Right to Life Federation urged consumers to boycott Roussel-Uclaf and Hoechst and said it may extend the boycott to other French products, if France did not stop its "chemical warfare against unborn children."}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}{ at 70 (quoting }{\i Anti-abortion Movement Calls for Boycott of French Pill}{, Reuters Library Report, Mar. 15, 1989).}}}{
\par \tab The NRLC has used boycotts as a tactic before.  In 1983, the NRLC boycotted all Upjohn products.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kolata, }{\i Boycott Threat}{, }{\i 
supra}{ note 193.  }}}{  The group sent members wallet-sized cards listing alternatives to drugs that Upjohn made.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Gina Kolata,  }{\i 
Any Sale in U.S. of Abortion Pill Still Years Away}{, }{\scaps N.Y. Times}{, Oct. 30, 1988, \'a71, at 1 [hereinafter Kolata, }{\i Any Sale}{].}}}{  In 1985, Upjohn stopped all research on drugs to induce abortion or prevent pregnancy.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kolata, }{\i Boycott Threat}{, }{\i supra}{ note 193.  }}}{  Upjo
hn representatives said that such research was stopped because of the "adverse regulatory climate in the United States" and because of the "litigious climate."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{ }{\i  Id.}}}{  Jessly Bradford, a spokeswoman for Upjohn, said that the boycott had no discernible effect; she claimed that Upjohn was "never able to detect any impact on sales of stocks."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Kolata, }{\i Any Sale}{, }{\i supra}{ note 240.}}}{  In 1993, Upjohn continued to sell two drugs that induced abortion despite NRLC's boycott.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\scaps   }{\i See}{ Calvin Sims, }{\i The Politics of Dealing with the Threat of Boycott}{, }{\scaps N.Y. Times}{, Mar. 14, 1993, \'a74, at 2.}}}{
  However, Dr. Glasow, as well as a representative of the Population Council, argued that the boycott was the principal reason for the halt on research.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn 
}{ }{\i  See}{ Kolata, }{\i Boycott Threat}{, }{\i supra}{ note 193.}}}{
  At the least, one can be sure that Dr. Glasow felt victory, as he reported, in 1988, that Upjohn discontinued an earlier second-trimester abortion drug, declined to develop a similar Ja
panese drug, and closed its research facilities for developing new drugs for contraception and abortion.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kolata, }{\i Any Sale}{
, supra note 240.}}}{
\par \tab Hoechst is a big business.  In the early 1990's, Hoechst's earnings approached 30 billion dollars, over 6 billion of which were in North America and mainly in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{Riding, }{\i supra}{ note 131. }}}{
  A highly organized boycott by Catholic hospitals, which control approximately 1/3 of all hospital beds in the United States, could severely reduce the company's sales; some say such a boycott was Hoechst's greatest fear.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{\scaps  Lawrence Lader}{, }{\scaps A Private Matter}{\i  }{125 (1995); Zitner, }{\i supra}{ note 84.}}}{  Dr
. Andre Ulmann, head of endocrinology in the research, development, and marketing department of Roussel-Uclaf, said the decision was a simple one; he said, "We [Roussel-Uclaf] were not going to put our $600 million in revenues from other products at risk.
"}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Sims, }{\i supra }{note 244.}}}{
  Dr. Baulieu confirmed that Roussel-Uclaf's reluctance to market the pill in the United States was due to a fear of a backlash in the United States against its majority shareholder, Hoechst.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Riding, }{\i supra }{note 131.}}}{  In 1990, Arielle Mouttet, the head of international marketing
 at Roussel-Uclaf, said that "selling in the United States [was] out of the question for the moment."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}}}{
  She said, "Hoechst has interests in the U.S. and cannot do any old thing.  It can't close its eyes to this reality."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i Id.}}}{  
\par \tab One may ask why the minority of Americans with moral opposition has such power.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i Pills and Parallels}{, }{\scaps Boston Globe}{
, Oct. 6, 1988, at 20 (quoting Dr. Irving Spitz of the Population Council saying "The presumed power of antiabortion groups is upsetting.  ... It should be challenged.")}}}{
  First, Roussel-Uclaf and Hoechst, as shown already in their original withdrawal of mifepristone from the French market, were and are sensitive to public opinion.  Second, Roussel-Uclaf and Hoechst had to c
onsider other economic factors in making their decision whether to market or supply mifepristone in the United States.  The threat of a boycott, in combination with these two factors, may have made the introduction of mifepristone into the United States a
 risk not worth taking.  
\par \tab Roussel-Uclaf had to determine whether marketing the drug would be profitable.  Pharmaceutical companies examine profitability of a new drug from four standpoints.  
\par \tab First, a company must assess the size of the market and the likely price of the product.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{\i supra}{ note 88, at 81;}{\i 
 U.S. Pharmaceutical Research and Development, and
 Its Impact on Women's Health:  the Technology Deficit in Contraception, Cancer, and Reproductive Disease and Conditions, Hearing Before the Subcomm. on Regulation, Bus. Opportunities, and Energy of the H.R. Comm. on Small Bus.}{
, 102d Cong. 18-22 (1992) (testimony of Joseph J. Spiedel, M.D., associate professor of clinical medicine, and head, Division of Nephrology, Robert Wood Johnson Medical School at Camden).}}}{
  Originally, experts estimated that the market for mifepristone would be large.  However, these estimates incorrectly assumed that mifepristone could be used as a contraceptive and compete in the $697 million oral contraceptive market.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{\i supra }{note 88, at}{\i  }{52, 81.}}}{  A more realistic estimate for United States sales of mifepristone is $100 million.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Zitner, }{\i supra}{ note 84.}}}{
  This is small compared to sales of other drugs;  United States consumers spent $11 billion on drugs to treat high blood pressure in 1996 and more than $1.4 billion on antihistamines.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{\fs16   }{
\par \tab Second, a company must assess the difficulty and expense of obtaining FDA approval.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{\i supra}{ note 88, at 81; }{\i 
U.S. Pharmaceutical Research and Development, and Its Impact on Women's Health:  the Technology Deficit in Contraception, Cancer, and Reproductive Disease and Conditions,}{ }{\i supra}{ note 254, at}{\i  }{18-22 (1992) (testimony of Joseph J. Spiedel, 
M.D., associate professor of clinical medicine, and head, Division of Nephrology, Robert Wood Johnson Medical School at Camden).}}}{  According to Dr. Baulieu, in order to meet FDA requirements, Roussel-Uclaf would have to spend at least $70 million.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\scaps Baulieu}{, }{\i supra}{ note 8, at 140.}}}{  As discussed in Part IV.C,
 Roussel-Uclaf believed that politics would be involved in the regulatory process.  Moreover, the Upjohn Company's failure to receive approval for Depo-Provera, an injectable contraceptive, after a long and expensive effort, already gave the United States
 regulatory system a reputation for being a hostile environment for contraception research and development.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Charo, }{\i supra}{
 note 88, at 83.   }}}{  Although the FDA may have had valid non-political reasons for its decisions, manufacturers perceive the process to be influenced by abortion politi
cs.  The Upjohn company, although it has tested mifepristone in its laboratories, has no interest in pursuing manufacture of it.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{
at 82.}}}{  A company representative said, "FDA standards are so high, and the chances of getting something approved so low, it just isn't worth it."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  Rosenfeld, }{\i supra }{note 85.}}}{  Also, the time necessary to obtain FDA approval shortens the period of market exclusivity reducing profits.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }
{\i See }{Muhl, }{\i supra}{ note 87, at 340.}}}{  
\par \tab Third, a company must factor in costs associated with product liability claims.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo,}{\i  supra }{note 88, at 81;}{\b  }{\i 
U.S. Pharmaceutical Research and Development, and Its Impact on Women's Health:  the Technology Deficit in Contraception, Cancer, and Reproductive Disease and Conditions,}{ }{\i supra}{ note 254, at}{\i  }{
18-22 (1992) (testimony of Joseph J. Spiedel, M.D., associate professor of clinical medicine, and head, Division of Nephrology, Robert Wood Johnson Medical School at Camden).}}}{  Since the product liability litigation regardin
g the Dalkon Shield IUD, pharmaceutical companies have been sensitive to the risk of litigation with reproductive products.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ }{\i 
U.S. Pharmaceutical Research and Development, and Its Impact on Women's Health:  the Technology Deficit in Contraception, Cancer, and Reproductive Disease and Conditions,}{ }{\i supra }{note 254, at}{\i  }{20}{\i  }{
(1992) (testimony of Joseph J. Spiedel, M.D., associate professor of clinical medicine, and head, Division of Nephrology, Robert Wood Johnson Medical School at Camden).}}}{
  Liability costs are a particular problem with reproductive products, because they treat people who are healthy at the beginning.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Zitner, }{\i supra}{ note 84.}}}{  Therefore, there is a high burden of proof for the safety of the product.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{
  Product liability can be high even for a safe product.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  G.D. Searle pulled its IUD from the market although it was never found to be defective, after the IUD drew more than 2000 lawsuits.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}
{  The cost of litigation, itself, could bankrupt a company, even if the company is blameless.  Moreover, liability insurance is difficult to get and very expensive.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   See}{ }{\i U.S. Pharmaceutical Research and Development, and Its Impact on Women's Health:  the Technology Deficit in Contraception, Cancer, and Reproductive Disease and Conditions,}{ }{\i supra }{note 254, at}{\i  }{20}{\i  }{
(1992) (testimony of Joseph J. Spiedel, M.D., associate professor of clinical medicine, and head, Division of Nephrology, Robert Wood Johnson Medical School at Camden).}}}{  Litigation also harms the company's reputation.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{\i\scaps  }{\scaps Baulieu}{, }{\i supra }{note 8, at 138-139.}}}{  
\par \tab Roussel-Uclaf and Hoechst h
ad specific reason to worry.  In addition to threats of boycotts, Hoechst had been threatened with the fear of litigation.  The RCR Alliance threatened to tie Hoechst up in litigation by finding plaintiffs in developing countries where the drug might be d
istributed.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{\i supra}{ note 88, at 70. }}}{
  Also, mifepristone, administered in combination with misoprostol, to terminate pregnancy has an almost 5% rate of failure.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Spitz. }{\i 
Early Pregnancy Termination}{, }{\i supra }{note 36, at 1241.  }{\i See also}{ Gary M. Samuelson, }{\i DES, RU-486, and Deja Vu}{, 2 }{\scaps J. Pharmacy & L.}{ 56 (discussing possible exposure of companies that manufacture RU 486 and compari
ng such liability to that of DES liability).}}}{  The company\rquote s biggest worry may have been the fact that mifepristone and misoprostol have been shown to have teratolog
ic effects.  If a woman is administered both mifepristone and misoprostol and carries her pregnancy to term, her fetus is at risk.  A child with birth defects is one of the most sympathetic plaintiffs.      
\par \tab According to Dr. Baulieu, liability profoundly worried Hoechst.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{\scaps Baulieu}{,}{\i  supra }{note 8, at 138.}}}{
  However, according to Eleanor Smeal, of the FMF, based on her interviews with scientists, manufacturers, and pharmaceutical leaders, the introduction of mifepristone is not a product liability issue.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{ note 97, at 46 (testimony of
 Eleanor Smeal, president, the Feminist Majority Foundation).}}}{  Ms. Mouttett, head of international
 marketing at Roussel-Uclaf, told the staff of the Subcommittee on Regulation, Business Opportunities, and Energy of the Committee on Small Business that Roussel-Uclaf does not think a lot about United States' product liability laws that make new drugs ri
s
ky ventures because of potential adverse effects.  Even so, product liability must have been at least a factor in Roussel-Uclaf and Hoechst's decisions regarding the marketing and distribution of mifepristone.  As Dr. John Spiedel, of the Population Crisi
s
 Committee, testified at a congressional hearing regarding development of reproductive products, "If you knew that there was a community of lawyers out there just waiting for a problem so they could sue you, you might think twice before bringing a drug to
 the U.S."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
U.S. Pharmaceutical Research and Development, and Its Impact on Women's Health:  the Technology Deficit in Contraception, Cancer, and Reproductive Disease and Conditions,}{ }{\i supra }{note 254, at}{\i  }{20}{\i  }{
(1992) (testimony of Joseph J. Spiedel, M.D., associate professor of clinical medicine, and head, Division of Nephrology, Robert Wood Johnson Medical School at Camden).}}}{
\par \tab Finally, a company must factor in costs associated with loss of public good will.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{\i supra}{ note 88, at 81; }{\i 
U.S. Pharmaceutical Research and Development, and Its Impact on Women's Health:  the Technology Deficit in Contraception, Cancer, and Reproductive Disease and Conditions,}{ }{\i supra }{note 254, at}{\i  }{18-22}{\i  }{
(1992) (testimony of Joseph J. Spiedel, M.D., associate professor of clinical medicine, and head, Division of Nephrology, Robert Wood Johnson Medical School at Camden).}}}{
  Such an assessment includes losses from a potential boycott.  In addition to a boycott, Hoechst feared the risk of being accused of mass murder and drawing atte
ntion to its relation to the manufacturer of cyanide gas used at concentration camps during the holocaust.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See }{\scaps Baulieu}{, }{\i supra}{
 note 8, at 108.}}}{  The RCR Alliance threatened to focus public attention on Hoechst's predecessor, I.G. Farben, as well as Hoechst's South African Assets.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See}{ Charo, }{\i supra}{ note 88, at 69.}}}{  Hoechst, led by a Roman Catholic President, also feared offending the Roman Catholic community and the Vatican.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ }{\scaps Baulieu}{, }{\i supra }{note 8, at 43.}}}{  In short, mifepristone meant trouble and disorder, and according to Dr. Baulieu, neither was welcome in Hoechst's boardroom.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 109.}}}{  
\par \tab This last factor appea
rs to have been the most influential in Roussel-Uclaf's decisions.  The staff of the Subcommittee on Regulation, Business Opportunities, and Energy of the Committee on Small Business conducted interviews with United States manufacturers and concluded that
 the "charged political environment, more than concerns about manufacturer liability or other problems, [was] the primary roadblock to domestic abortifacient and contraceptive research."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{ note 97, at 67 (staff memorandum).}}}{
  Ms. Mouttet, the company's marketing director, told the subcommittee staff that the company's marketing strategy is more affected by real or perceived political issues than questions of sales and profit margins.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}{ at 71.}}}{  She said that anti-abortion politics and the threat of a United States' boycott are "something we [Roussel-Uclaf] take very seriously."}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}}}{  
\par \tab After an assessment of these four factors, it is likely that Roussel-Uclaf did not estimate the profitability of mifepristone in the United States to be high.  The potential market, as compared to other drugs, was small, in th
e early nineties.  Roussel-Uclaf would need to invest a substantial amount of time and money to obtain FDA approval.  The chance of product liability litigation was high due to the rate of failure as well as the risk to the fetus.  Lastly, the threat of b
oycotts, as well as other smear campaigns stimulated by the political controversy over abortion in the United States, frightened the companies.  As Dr. Baulieu said, "With such a risk and no glory, what was the motivation?"}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\scaps Baulieu}{, }{\i supra }{note 8, at 140.}}}{   
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i E. }{ }{\i Pressuring Roussel-Uclaf}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab 
Advocates of the abortion pill decided they needed to provide the motivation.  As discussed before, infra Part IV.A, the FDA will not approve a drug for marketing and distribution in the United States unless a sponsor applies for approval.  Pro-choice adv
ocates and medical researchers decided to create political pressure to balance the anti-abortionists' threats so that Roussel-Uclaf would take the necessary steps to bring mifepristone to the United States.  Jennifer Jackman of the FMF said, "Roussel-Ucla
f is not convinced that there is public support for RU 486 in the United States.  The sense we got from them is that the more public support we could demonstrate, the more willing Roussel-Uclaf would be to make it available in the United States."}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Finter, }{\i supra}{ note 78.}}}{  As was s
aid at a 1991 Congressional hearing, "some kind of activity must ... come that would show this company that it is in their interests to act in what it seems the majority indicate are the interests of the ... country."}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{
 note 97, at 49 (testimony of R.L. MacKenzie, chairman and CEO, Gynopharma, Inc.).}}}{
\par \tab The FMF set out to garner support fo
r mifepristone and make Roussel-Uclaf aware of such support.  In June of 1989, after traveling to France to assess the potential of mifepristone, the FMF launched the nation's largest public education drive on mifepristone.  Eleanor Smeal, president of th
e
 FMF, said "We intend to visit the pharmaceutical leaders, the medical health leaders to urge them to rise up against this ... know-nothing movement that is denying the best of medical research and the best that modern medicine can provide for the modern 
woman."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Charo, }{\i supra}{ note 88, at 72 (quoting }{\i Abortion Pill to Be Tested as Contraceptive}{, }{\scaps Chicago Trib}{
., Oct. 3, 1989, News, at 5.  }}}{   After the July 1989 decision of the Supreme Court in }{\i Webster v. Reproductive Services}{
, where the Court expanded state powers to restrict abortion services, even those privately funded, in state facilities, the FMF renewed its support for mifepristone, asserting the greater need for office-based abortion in the wake of }{\i Webster }{
and its potential impact on abortion clinics.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Charo, }{\i supra}{ note 88, at 72.  }{\i See also}{
 Webster v. Reprod. Health Serv., 492 U.S. 490 (1989).}}}{  
\par \tab The FMF was able to garner support.  In July of 1990, a ten member delegation, including Eleanor Smeal, other feminist leade
rs, and prominent scientists, flew to Paris to meet with Roussel-Uclaf and Hoechst officials to urge the introduction of mifepristone into the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See}{ }{\i FMF - The Fight to Make RU486 Legal}{ (visited Jan. 18, 1999) <http://www.feminist.org/gateway/ru486two.html>;  Glazer, }{\i supra}{ note 96.  }{\i See also}{ }{\i RU 486; The Import Ban and Its Effect on Medical Research}{, }{
\i supra}{ note 108, at 187-259 (Feminist Majority Foundation, Scientists, Health Care Professionals, and Academicians for RU 486, petition signatories).}}}{  During discussions with Dr. Sazik, president of Roussel-Uclaf, the delegation presented over 115
,000 petitions from American citizens in support of RU-486.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i FMF - The Fight to Make RU486 Legal}{
 (visited Jan. 18, 1999) <http://www.feminist.org/gateway/ru486two.html>.}}}{  According to Dr. Baulieu, Dr. Sazik told the delegation that he was already persuaded and that its target was Hoechst.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{\scaps Baulieu}{, }{\i supra }{note 8, at 137.}}}{  The delegation also met with Hoechst officials, but, according to Baulieu, "it did not change anyone's mind there."}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}}}{  In February of 1992, yet another FMF delegation met with officials from Hoechst, delivering an additional 110,000 petitions.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i FMF - The Fight to Make RU486 Legal}{ (visited Jan. 18, 1999) <http://www.feminist.org/gateway/ru486two.html>.}}}{
  In April of 1992, after receiving a $10 million gift}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Susan Jenks, }{\i 
Feminist Group Plans "Economic Pressure Campaign" for Access to RU 486}{, }{\scaps J. Nat'l Cancer Inst.}{, April 1992, at 562-563.}}}{, the FMF announced its Web of 
Influence Campaign; the goal of the Web of Influence Campaign was to educate the public on United States' companies that do business with Hoechst and Roussel-Uclaf and to encourage those companies to ask that mifepristone be distributed in the United Stat
es.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i FMF - The Fight to Make RU486 Legal}{ (visited Jan. 18, 1999) <http://www.feminist.org/gateway/ru486two.html>.}}}{
\par \tab Meanwhile, other feminist leaders were at work.  Faye Wattleton, President of the Planned Parenthood Federation of America, made three trips to Paris to plead with Roussel-Uclaf.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{\i   See}{ }{\scaps Baulieu}{, }{\i supra }{note 8, at 144-145.}}}{  Molly Yard, the former President of the National Organization for Wome
n and Dr. Allen Rosenfield, the former chairman of the Planned Parenthood Federation, lobbied Roussel-Uclaf on behalf of their delegations.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}
{ }{\scaps Lader}{, }{\i supra}{ note 248, at 126.}}}{  At the National Women's marches in Washington D.C., leaders spoke about the importance of mifepristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See id.}}}{  Feminists also picketed outside plants of a Hoechst subsidiary in New Jersey.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{\b   
\par \tab }{Others attempted to use their political clout to influence Roussel-Uclaf.  Representative Barbara Boxer (D-CA) stimulated seventy of her colleagues in Congress to request that Roussel-Uclaf make the drug available.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ William Regelson, }{\i RU 486:  How Abortion Politics Have Impacted on a Potentially Useful Drug of Broad Medical Application}{, }{\scaps Perspectives in Biolo
gy and Medicine}{, Spring 1992, at 330, 334.}}}{
  In a letter to Dr. Sazik, the congress men and women assured Roussel-Uclaf that they were "willing to remove, through legislation, policy or regulatory obstacles to medical progress that are motivated by political rather than scientific concerns."}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\scaps Baulieu}{, }{\i supra}{ note 8, at 152.}}}{
  Former New York City Mayor David Dinkins wrote to President Bush, Roussel-Uclaf officials, and the mayors of 33 major cities urging them to formally encourage Roussel-Uclaf to begin exporting mifepristone into the country.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Finter, }{\i supra }{note 78.}}}{  Th
e citizens of New Hampshire passed a resolution encouraging the introduction of mifepristone into the United States for use as a method of early pregnancy termination as well as for research on breast and other cancers}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{; the state of California followed, passing a similar resolution.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{ }{\i  See }{Jenks, }{\i supra}{ note 295.}}}{
\par }{\b \tab }{Congressman Ron Wyden chaired three congressional hearings discussing both the obstacles to commercialization of mifepristone in the United States and the effect of the import alert on medical research regarding mifepristone.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i RU 486: The Import Ban and Its Effect on Medical Research}{, }{\i supra}{ note 108; T}{\i he Safety and Effectivene
ss of the Abortifacient RU 486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{ note 97; }{\i The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{, }{
\i supra}{ note 156.}}}{  Medical researchers participated in the hearings testifying about their medical research with mifepristone and their difficulties obtaining the drug from Roussel-Uclaf.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{discussion}{\i  infra}{ Part IV.C.}}}{  During these hearings, Mr. Wyden and the medical researchers attempted to mobilize
 the medical community and assert pressure on Roussel-Uclaf.  Clinicians in California formed a group, "Physicians for RU 486" to protest continuing research restrictions.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{ }{\i  See}{ Jenks, }{\i supra }{note 295.}}}{  In addition, on February 6, 1991, Mr. Wyden introduced a bill to make Import Alert
 66-47 ineffective and to prevent the issuance of another import alert unless the FDA found that such drug was being imported for illegal use.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See }{H.R. 875, 102d Cong. (1991).  Senator Cranston introduced the same bill in 1992.  }{\i See}{ S. 2268, 102d Cong. (1992). }}}{  68 other congress men and women co-sponsored the bill, slightly more than half the names needed to force it out
 of committee or at least get another hearing on mifepristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ H.R. 875; Jenks, }{\i supra }{note 295.}}}{  The bill was never passed.

\par \tab Despite all of these efforts, Roussel-Uclaf showed no signs that it planned to introduce the drug into the United States in the near future.  In 1990, Ms. Mouttet,
 head of international marketing at Roussel-Uclaf, said that "selling in the United States [was] out of the question at the moment."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Riding, }{\i 
supra }{note 131.}}}{  In December of 1991, Ms. Mouttet said that the company would not provide the drug for research on its abortion properties in the United States because it had no plans to market the drug here in the near future.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Glazer, }{\i supra}{ note 96.}}}{
  She said, "We consider abortion a very controversial issue in the United States.  We don't want to be involved in this debate.  So there is no reason to set up a trial for RU 486."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}}}{  
\par \tab Hoechst-Roussel Pharmaceuticals Inc. of Somerville, New Jersey, owned by both Hoechst and Roussel-Uclaf}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  In December of 1991, Hoechst AG, or Hoechst, was 100% owner of Hoechst corporation.  Hoechst corporation was holding company and owner of 100% of Hoechst Celanese.  Hoechst-Roussel Pharmaceuticals Inc. was owned 80% by Hoec
hst Celanese and 20% by Roussel-Uclaf.  }{\i See}{ }{\i The Safety and Effectiveness of the}{ }{\i Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra }{
note 97, at 336-337 (letter to Congressman Wyden from Ernest H. Drew, President and CEO of Hoechst Celanese).}}}{, held the option rights to apply for government approval to market mifepristone in the United States.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 336-338.}}}{  In 1985, Hoechst-Roussel Pharmaceuticals gave up its rights to test and market mifepristone in the United States.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 336-338.}}}{
  Hoechst-Roussel Pharmaceuticals said it was not interested in testing and marketing the drug because it did not fit in with the Hoechst-Roussel Pharmaceuticals product line and scientific and product expertise.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{ Hoechst-Roussel Pharmaceuticals makes chemicals, fibers, plastics, and printing materials as well as a variety of drugs.  According to a Standard & Poor's registe
r of corporations in 1988, the company had annual sales of $1.7 billion.  Kolata, }{\i Boycott Threat}{, }{\i supra }{note 193.}}}{
  Like Roussel-Uclaf, Hoechst-Roussel Pharmaceuticals showed no signs of changing its mind.  In March 1990, Edward Norton, a spokesman for Hoechst-Roussel Pharmaceuticals,  defined the company's position.  He sa
id, "We've been petitioned, we've been yelled at, and we've been telephoned by everybody.  But our formal position hasn't changed in two years, and I don't expect it to change."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\scaps Lader}{, }{\i supra}{ note 248, at 126.}}}{
\par }{\b \tab }{After Hoechst-Roussel Pharmaceutical refused to test and market mifepristone
, Roussel-Uclaf was free to license the drug to other companies in the United States.  However, in line with its policy of not involving itself within the American abortion debate, Roussel-Uclaf made no efforts to license the drug to another company.

\par \tab Sinc
e the usual methods, such as lobbying and petitioning, did not seem to be having an effect on Roussel-Uclaf's stance, one man, Lawrence Lader, decided to try a more drastic approach.  As discussed infra Part II.B, Lawrence Lader has fought for the women's
 right to choose since the early 1960's.  Mr. Lader fought long and hard for the legalization of abortion.  In 1966, he published a survey of abortion practices.  His book is cited eight times in the Supreme Court's }{\i Roe v. Wade}{ decision.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Zitner, }{\i supra}{ note 84.}}}{  He has made the i
ntroduction of mifepristone into the United States his next battle.  He formed the Abortion Rights Mobilization, an organization committed to the introduction of mifepristone in the United States.  In the early nineties, Mr. Lader was looking for a way to
 "dramatize the absurdity of their [Roussel-Uclaf, Hoechst, and President Bush] positions and bring the importance of RU 486 to the country and the media in vivid and simple terms."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  L}{\scaps ader}{, }{\i supra }{note 248, at 129.}}}{  
\par \tab Drawing on a tactic used by his mentor, Margaret Sanger, the birth control pioneer}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Margaret Sanger had arranged for a Japane
se doctor to mail contraceptives to her medical director in New York, making sure that the government knew of it and the package was seized.  }{\i See id.}}}{
, Mr. Lader devised a perfect plan.  He would have a pregnant American woman go to Britain and secure one dose of mifepristone, which she could carry to New York to be administered by one of ARM's doctors.  Such action would directly challenge 
Import Alert 66-47 and be sure to draw media attention.  Putting the plan into action was difficult.  Mr. Lader had to find a doctor in Britain willing to supply the drug, an American doctor to administer the pills, and a woman suitable for the task and p
r
epared to handle the consequences.  That woman was Leona Benten.  Ms. Benten traveled with Mr. Lader to Britain, where they received the supply of mifepristone, 600 milligrams (one dose).  On July 1, 1992, Ms. Benten and Mr. Lader returned to the United S
tates, she carrying the mifepristone, he the prostaglandin, and, as they had hoped, they were stopped at Customs.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 135-136.}}}{
  ARM had sent notification of its challenge of the law to both the FDA and U.S. Customs; ARM had also notified the media.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}{ at 135.}}}{
  Upon their return,
 Ms. Benten and Mr. Lader were greeted by a barrage of reporters at the airport.  According to Mr. Lader, he, Ms. Benten, and ARM accomplished their mission of "focusing national attention on RU 486 and at the same time putting pressure on the government 
and Hoechst-Roussel to start the long process of bringing the pill to American women."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i Id.}{ at 136.}}}{
\par \tab In accordance with Import Alert 66-47, Ms. Benten was not allowed to bring the mifepristone into the United States; Customs seized the pills.  The plan was not over yet
, however.  Ms. Benten, with the help of ARM, challenged the import alert in court.  At a hearing, before Federal District Judge Charles P. Sifton, on July 10, 1992, lawyers argued, on behalf of Ms. Benten, that the FDA regulations covered importation of 
an unapproved drug for personal use, that the ban terming mifepristone dangerous was backed by no scientific evidence, and that the FDA had not asked for public testimony, regarding the regulations, as was required by the administrative law.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 137.}}}{  Mr. Lader fel
t that they would get a fair chance since Judge Sifton was appointed by President Carter, but he was surprised by the judge's strong support.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See id.}{ }}}{  On July 14, Judge Sifton ruled that the Government had acted illegally when agents of the United States Customs Office and the FDA confiscated the pills and ordered the government to return the pills to Ms. Benten immediately.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Benten v. Kessler, 799 F.Supp. 281 (E.D.N.Y. 1992).}}}{
  Judge Sifton reasoned that the regulations which, combined with the import alert, instructed Customs to seize the drug, were promulgated wi
thout notice-and comment-procedures, as required by Federal law and therefore, Ms. Benten was entitled to a return of the drugs.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{

\par \tab The victory for Ms. Benten was short.  On the afternoon of July 14, the United States Court of Appeals for the Second Circuit stayed Judge Sifton's order.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See}{ Philip J. Hilts, }{\i Thomas Expedites Suit on Abortion Pill}{, }{\scaps N.Y. Times}{, July 16, 1992, at A18.}}}{
  Her lawyers immediately filed an emergency request with the Supreme Court to uphold Judge Sifton's order and erase the appeals court's stay.  The Supreme Court accepted the appeal.  However, on July 18, the Supreme Court, by
 a seven to two vote, refused to order the government to return the pills to Ms. Benten.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Benten v. Kessler, 505 U.S. 1084, 1085 (1992).}}}
{  The Supreme Court held that Ms. Benten failed to demonstrate that there was a substantial likelihood of success on her claim that she was entitled to the return of t
he pills because the regulations, which Customs officials relied on to seize the pills, were promulgated without notice-and-comment procedures required by Federal law.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{ }{\i  See id.}}}{  Justice Stevens argued, in dissent, that the Government's holding of the pills would constitute an undue burden upon Ms. Benten's constitutionally protected abortion rights.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 1085-1086.}}}{
  The Court refused to express a view on the merits of this assertion, concluding that such a claim was not properly before the Court for it was not addressed by the District Court, the Court of Appeals, or Ms. Benten.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 1085.}}}{ 
\par \tab The victory was a bit sweeter for Mr. Lader and ARM.  Mr. Lader said, "The case had been a legal gamble from the start, of course, but it had turned out far more successfully than anyone expected.  Leon
a personally had lost, but the movement had made a striking advance in bringing the issue of RU 486 to national attention and shaking up the government's rigidity in the process."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\scaps Lader}{, }{\i supra }{note 248, at 139. }}}{
\par \tab The tactic did not, however, encourage Roussel-Uclaf to change its stance 
regarding the introduction of mifepristone into the United States.  Frustrated by Roussel-Uclaf, advocates of mifepristone began to brainstorm and explore other avenues through which introduction of mifepristone into the United States could be achieved.  
Some suggested approving the drug in the United States for a use, other than as an abortifacient, such as a post-coital contraceptive or a drug to widen the cervix.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   See, e.g., }{Karen F. Richards, }{\i RU 486:  A Promising Birth Control Device Entangled in the Abortion Debate}{, 6}{\scaps  J. Pharmacy & L}{
. 117 (1997) (suggesting marketing mifepristone as a birth control device to avoid political taint);  Kari Hanson, }{\i Approval of RU-486 as a Postcoital Contraceptive}{, 17 }{\scaps U. Puget Sound L. Rev.}{
 163 (1993) (suggesting marketing mifepristone as a postcoital contraceptive rather than as an abortifacient).  One problem with such theories is that ,as d
iscussed infra Part I.C, the safety and effectiveness of mifepristone as a form of contraception has yet to be proven.}}}{  Once a drug is approved for marketing and distribution in the United States, it can be pre
scribed by physicians, at their discretion, for any condition.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{37 Fed. Reg. \'b6 16,503 (1972); 52 Fed. Reg. \'b6 8802-8803. }{\i 
 See also}{ 21 C.F.R. \'a7 312.2(d) (1999).}}}{  Therefore, once approved, physicians could use the drug to perform a medical abortion.  Advocates of this strategy argued that it would accelerate the process because it would avoid the abort
ion controversy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{Richards, }{\i supra }{note 335; Hanson, }{\i supra}{ note 335.}}}{
  This strategy was never fully developed or explored, except on a theoretical level.  Another possible route toward introduction of mifepristone into the United States was through the individual states.  For example, in California, under 
state law, the state bureau can approve the sale of drugs not approved by the FDA, provided that they have been tested and are manufactured and distributed solely within California.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{\i   See }{Charo, }{\i supra}{ note 88, at 79.}}}{  Lawrence Lader, ARM, and the FMF announced another strategy - the remova
l of Roussel-Uclaf's patent on mifepristone.  ARM had conducted research regarding a little known law authorizing patent removal in certain circumstances.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See}{ }{\scaps Lader}{, }{\i supra}{ note 248, at 147; 28 U.S.C.A. \'a7 1498 (West Supp. 1999).}}}{  ARM lawyers found that patent removal was rare and most patent removals had occurred during emergency situations in both world wars.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{\scaps  Lader}{, }{\i supra }{note 248, at 147.}}}{
  According to Mr. Lader, lawyers felt that this approach could be kept as a threat to Roussel-Uclaf, although its chances of success were skimpy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{
\i See id.}{ at 147.  }{\i See also }{Lawrence Lader, }{\i RU-486, Made in America}{, }{\scaps N.Y. Times}{, Mar. 17, 1994, at A23 [hereinafter Lader, }{\i RU-486, Made in America}{].}}}{
  Finally, some suggested starting a company to research, develop, and market the drug in the United States.  Eleanor Smeal indicated that the FMF was interested in forming a consortium of small pharmaceutical companies.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra}{
 note 97, at 59 (testimony of Eleanor Smeal, President of the Feminist Majority Foundation); Jenks, }{\i supra }{note 295.}}}{  Other family planning and feminist health groups, as well as groups of financiers, expressed an interest as well.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Charo, }{\i supra}{ note 88, at 45-46.}}}{   
\par \tab Before any of these strategies came to fruition, Roussel-Uclaf showed signs that it may be willing to discuss possible methods of introduction into the United States.  What changed Roussel-Uclaf's mind?  It was the election of President Clinton. 

\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i F.  The Role of the President}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab 
From 1980 to 1992, the United States was run by Republican leaders, President Reagan and President Bush.  Each of whom was a pro-life advocate.  Reagan advocated that life begins at conception and asserted that the unborn s
hould be protected by the constitutional guarantees of life, liberty, and the pursuit of happiness.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See }{\scaps Tatalovich}{, }{\i supra}{
 note 190, at 156.}}}{  Reagan declared January 17, 1988 the National Sanctity of Human Life Day, dedicated to protecting the unborn.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ }{
\scaps Baulieu}{, }{\i supra }{note 8, at 134.}}}{  In 1988, Bush carried the pro-life mantle for his party and throughout his term, sustained the pro-life policies of his predecessor.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{\i   See}{ }{\scaps Tatalovich}{, }{\i supra }{note 190, at 157.}}}{  During the Reagan-Bush years, abortion has been said to have colored appointments and policies in ways that hurt women.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Sara Engram, }{\i Clinton Era Means Reproductive Freedom for Women}{, }{\scaps Toronto Star}{, Nov. 9, 1992, at D1.}}}{  The Reagan-Bush administration instituted
 and administered two policies, in particular, that were clearly anti-abortion.
\par \tab At a United Nations population conference in Mexico City, James Buckley, the head of the United States delegation, outlined the Reagan administration's plan to tighten enforce
ment of a policy barring the use of United States foreign aid to pay for or promote abortions.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Robert Blair Kaiser, }{\i 
Population Conference Hears Abortion Warning}{, }{\scaps San Diego Union-Trib.,}{ Aug. 9, 1984, at A3.}}}{
  The policy, coined the Mexico City Policy, directed the Agency for International Development, AID, to withhold AID funds from nongovernmental organizations, or
 NGOs, that engage in a wide range of activities, including providing advice, counseling, or information regarding abortion or lobbying a foreign government to legalize or make abortion available.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\b   }{\i See}{ Memorandum, Mexico City Policy, }{\scaps Pub. Papers}{ 10 (Jan 22, 1993).}}}{  AID suspended contributions to the International Planned 
Parenthood Federation and the United Nations Fund for Population Activities on the grounds that in some cases they finance abortion clinics.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See
}{ Riding, }{\i supra }{note 131.}}}{  It has been said that such a policy affected the World Health Organization's, WHO, advocacy of mifepristone out of fear that the United States would retaliate by cutting contributions to its budget.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{
  In 1982, WHO signed an agreement with Roussel-Uclaf.  Under the agreement, in the event that Roussel-Uclaf decided not develop mifepristone in a WHO member nation who wanted to use it, Roussel-Ucl
af would provide the mifepristone directly to WHO or cede rights to another manufacturer.  }{\i See}{ }{\scaps Baulieu}{, }{\i supra}{ note 8, at 30.}}}{
\par \tab In February of 1988, Reagan imposed what has come to be known as the gag rule.  According to the gag rule, the counseling of women on the option of having an abortion was prohibited in 4,000 family planning clinics that receive Federal financing.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ 42 C.F.R. Part 59.8 (a)(1) (1992) (suspended in 1993); 53 Fed. Reg. \'b6 2922 (1988). }}}{
  The Department of Health and Human Services, HHS, attempted to modify the gag rule, at what it argued was President Bush's direction, to allow doctor's to freely communicate and advise their Title X patients regarding abortion.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Nat'l Family Planning and Reprod. Health Ass'n, Inc. v. Sullivan, 979 F.2d 227, 230 (D.C. Cir. 1992).}}}{  However, in }{\i 
National Family Planning and Reproductive Health Association, Inc. v. Sullivan}{, a Federal Court of Appeals said that the HHS could not make such a modification without adhering to notice-and-comment rulemaking requirements.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i id.}{ at 241.}}}{
\par \tab With the election of President Clinton, a pro-choice advocate, United States policy related to abortion began to change.  During his 1992 campaign, Clinton promised to select only Supreme Court judges who supported abortion rights.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Dan Balz and Edward Walsh,}{\i  Clinton 'Close to Decision' on Ticket; Gore Seen as Leading Contender; Kerrey Makes Trip to Arkansas}{, }{\scaps 
Wash. Post}{, July 8, 1992, at A1.}}}{  He also expressed his view that mifepristone should be tested and examined in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.
}}}{  Soon after his election, Clinton took action supporting this statement.  On the twentieth anniversary of }{\i Roe v. Wade}{, Clinton signed five abortion-related memorandums.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 58 Fed. Reg. \'b6 6439 (1993) (directing Department of Defense to permit abortion in military hospitals overseas if women pay for the operation themselves); 58 Fed. Reg. \'b6
 7455 (1993) (ordering Secretary of Health and Human Services to suspend the gag rule); 58 Fed. Reg. \'b6
 7457 (1993) (directing Secretary of Health and Human Services to lift the moratorium on transplant research using organs from aborted fetuses), 58 Fed. Reg. \'b6 7459 (1993) (directing the Secretary of Health and Human Servic
es to instruct the  FDA to review import alert on RU-486)}{\b , }{Memorandum, Mexico City Policy, }{\scaps Pub. Papers}{ 10 (Jan 22, 1993) (ordering AID to suspend the Mexico City Policy).}}}{
  Clinton denounced the Mexico City Policy, as not required by law and unwarranted.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Memorandum, Mexico City Policy, }{\scaps Pub. Papers}{
 10 (Jan 22, 1993). }}}{  He directed AID to remove the restrictions of the policy on all current AID grants to NGOs and to exclude them from future grants.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See id.}}}{  Clinton ordered the Secretary of Health and Human Services to suspend the gag rule pending the promulgation of new regulations in accordance with the notice-and-comment procedures of the Administrative Procedure Act.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 58 Fed. Reg. \'b6 7455 (1993).  On February 5, 1993, the Secretary of Health and Human Services suspended the gag rule.  }{\i See}{
 58 Fed Reg. \'b6 7468 (1993).}}}{  Clinton, also, ordered the Department of Health 
and Human Services to review the import alert of mifepristone and promptly assess initiatives by which the department could promote the testing, licensing, and manufacturing of mifepristone in the United States.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ 58 Fed. Reg. \'b6 7459.  It was so ordered on February 5, 1993. }{\i  See}{ 58 Fed Reg. \'b6 7468 (1993).}}}{  As Clinton signed the above memoranda, he 
called for "an America where abortion is safe and legal but rare."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Remarks by the President During Signing of Presidential Memoranda, }{\scaps 
Pub. Papers}{ 7-8 (Jan. 22, 1993).}}}{
\par \tab Immediately after Clinton's memorandum to the Secretary of Health and Human Services regarding mifepristone, the FDA focused on encouraging and facilitating the submission of an NDA for mifepristone.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ }{\i RU-486, Status Report on the U.S. Commercialization Project, Transfer of Anti-Progestin Technology to the United States}{, 103d Cong. 6 (1994) (testimo
ny of Hon. David M. Kessler, M.D., Commissioner, FDA).}}}{
  The then Commissioner of the FDA, Dr. David Kessler, immediately wrote to Dr. Sazik, the President of Roussel-Uclaf, requesting a meeting to discuss the FDA's interest in receiving an NDA and met with Dr. Sazik on February 24, 1993.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{; Hilts, }{\i Door May Be Open}{, }{\i supra }{note 4.}}}{  The tw
o met on February 24, 1993 and discussed how the drug could be brought to market in the United States.  Roussel-Uclaf emphasized the importance of finding a way to achieve this goal without the involvement of  Roussel-Uclaf.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i Meeting with Roussel-Uclaf on RU-486}{ (visited Jan. 21, 1999) <http://www.fda.gov/bbs/topics/Answers/Ans00472.html>.}}}{  They agreed on three other gr
oups suitable to bring the drug to market in the United States: a United States pharmaceutical firm, a research center, or a university.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.
}}}{  Dr.  Kessler received a strong commitment from Dr. Sazik that he would find a way to bring mifepristone to the United States market.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 }{\i RU-486, Status Report on the U.S. Commercialization Project, Transfer of Anti-Progestin Technology to the United States}{, }{\i supra}{ note 363, at 6 (testimony of Hon. David M. Kessler, M.D., Commissioner, FDA).}}}{
  On April 20, 1993, Dr. Kessler and Dr. Sazik held another meeting and the FDA announced that Roussel-Uclaf agreed to license the drug and technology to the Population Council.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 7; Warren E. Leary, }{\i Maker of Abortion Pill Reaches Licensing Pact with U.S. Group}{, }{\scaps N.Y. Times}{, Apr. 21, 1993, at A18.}}}{  According to the FDA, Roussel-Uclaf agreed to provide the FD
A with its toxicology and chemistry data on the drug within a few weeks.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Leary, }{\i supra}{ note 368.}}}{
\par \tab However, a year later, in April of 1994, Roussel-Uclaf and the Population Council had not reached an agreement.  According to reports, negotiations were on-going through out the yea
r, but no agreement could be reached.  Why were negotiations taking so long?  Some rumored that Hoechst was trying to stall the negotiations in the hope that Clinton would not be re-elected in 1996 and in that event, that the United States would exert les
s pressure on the company to bring mifepristone to the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Seelye, }{\i Accord Opens Way}{, }{\i supra}{ note 5.}}}{
  It was also rumored that Hoechst was under heavy pressure from Pope John Paul II to halt use of the drug.  A government aide said that one meeting between Hoechst officials and Clinton 
administration officials was devoted almost entirely to discussions of the religious pressures being exerted on the company.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  Others familiar with the negotiation believed Roussel-Uclaf to be concerned about potential product liability, as well as still concerned about the threat of boycott.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ Tamar Lewin, }{\i Plans for Abortion Pill Stalled in U.S.}{, }{\scaps N.Y. Times}{, Oct. 13, 1993, at A17 [hereinafter Lewin, }{\i Plans for Abortion Pill}{]; }{\scaps Lader}{, }{\i supra}{
 note 248, at 153 (stating that Hoechst asked to be indemnified for any loss of business in the United States).}}}{
  Sandra Waldman, director of public information at the Population Council, said that Roussel-Uclaf's primary concern was that the drug be controlled and regulated to ensure proper use.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Seelye, }{\i Accord Opens Way}{, }{\i supra}{ note 5.  }{\i See also}{ Lewin, }{\i Plans for Abortion Pill}{, }{\i supra}{ note 372.}}}{  A representative of Roussel-Uc
laf also indicated that extensive discussions were conducted regarding the prescription and distribution system of the drug in this country in order to protect the health and safety of American women.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i RU-486, Status Report on the U.S. Commercialization Project, Transfer of Anti-Progestin Technology to the United States}{, }{\i supra}{
 note 363, at 16 (testimony of Lester Hyman, Swidler & Berlin, representing Roussel Uclaf).  In France, t
here is a large amount of government control of doctors and clinics, especially in this field.  According to Roussel-Uclaf, it is easier to assure proper education, delivery, and supervision of the procedure in France than it will be in the United States.
 }{\i  See Id. }}}{  
\par \tab Whatever the reason, advocates of mifepristone beca
me quickly frustrated once again and renewed pressuring Roussel-Uclaf with vigor.  The FMF had never stopped its campaign.  In November of 1992, after Clinton's election, the FMF sent letters to Roussel-Uclaf and Hoechst informing them that Clinton's elec
tion and the election of more women and pro-choice members of Congress effectively removed the political obstacles to mifepristone in this country.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }
{\i FMF - The Fight to Make RU486 Legal }{(visited Jan. 18, 1999) <http:www.feminist.org/gateway/ru486two.html>.}}}{  Frustrated with negotiations, in January of 1994, the tenth month of such negotiations, the FMF shipped ano
ther 50,000 petitions to Hoechst on the 20th anniversary of Roe v. Wade.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  In February of 1994, it was announced that British clinics would begin making mifepristone available to American women}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Tamar Lewin, }{
\i British Clinic to Offer Abortion Pill to Americans}{, L.A. Daily News, Feb. 18, 1994, at N13.}}}{; advocates hoped that increased availability of mifepristone would help pressure Roussel-Uclaf to allow it to be sold in the United States.
\par \tab Once again, Lawrence Lader found it necessary to take more drastic measures to make Roussel-Uclaf stand up and take notice.  Mr. Lader, in conjunction with ARM, decided to make
 and test a version of the pill in the United States to "prove to Roussel that we have competitive American scientists and that we refuse to be stalled any longer by Roussel's blockade of American interests."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\scaps Lader}{, }{\i supra }{note 248, at 141-142.}}}{  The Chinese government had already made a proven copy of the pill.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}{ at 141.}}}{  ARM ran tests to compare Roussel-Uclaf's pill with the Chinese copy and determined that the active ingredients in both pills were indistinguishable.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 142.}}}{  At a press conference in New York on February 17, 1993, Mr. Lader announced the results of such testing.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at}{\i  }{142-143.}}}{
  ARM then set out to make its own copy of Roussel-Uclaf's pill.  After raising money and finding skilled scientists, both difficult tasks, ARM built its own lab in Westchester, New York and began producing a copy of RU-486.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{
 at 143-145.  ARM's efforts were further complicated by the fact that it originally planned to test the pill under New York's mini-FDA law, which allowed a new 
drug to be cleared by state authorities rather than Federal FDA.  Under such a law, every ingredient in the pill had to be bought within the boundaries of New York.  }{\i See id.}}}{  In la
te March of 1993, ARM had produced 50 grams of mifepristone, only enough to perform a medical abortion on about 100 women.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  ARM could test the pills, without a patent problem, as long as the pills were not sold to the women.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ 35 U.S.C.A. \'a7
 271(e)(1) (West Supp. 1999); Under 35 U.S.C. 271 (e)(1), ARM is free to copy the drug for research purposes as long as it does not sell it for profit; such provision also includes the distribution as part of a research trial.  }{\i See id.}}}{
  Mr. Lader said "testing of this small a number was simply symbolic, [to] prove to the country that RU 486 could be made here, and [that] a lot more of the drug would be available shortly thereafter."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\scaps Lader}{, }{\i supra}{ note 248, at 146-147.}}}{  In a press conference, on April 1, 1993, Mr. Lader showed the pill to reporters, a
sserting that ARM's purpose was to pressure Roussel-Uclaf and instigate them into "immediate and decisive action."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}{ at 149.}}}{
  ARM also sent a letter to the Population Council offering its full cooperation.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{ 
\par \tab Meanwhile, ARM had learned from its Washington contacts that the FDA might give serious consideration to approving testing of its mifepristone pill.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See id.}{ at 148.}}}{  In May of 1993, ARM met with a panel of FDA scientists, whom suggested that ARM cross-reference under the Population Council's existent IND.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{ }{\i  See id. }{at 151; 21 C.F.R. \'a7 312.23(b) (1999) (allowing reference to information submitted previously).}}}{  The Population Cou
ncil said that it had no objections to ARM cross-referencing to its IND, but that Roussel-Uclaf would also have to agree, since the research data for the Population Council's IND came from Roussel-Uclaf.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\scaps Lader}{, }{\i supra}{ note 248, at 152 ; 21 C.F.R. \'a7 312.23(b) (requiring authorization of person who submitted the information previously).}}}{
  ARM decided it would have to do its own testing to
 obtain an IND.  ARM ran toxicology tests on rats and dogs to prove that no ingredient in its pill could be dangerous; it also ran bioequivalency studies on rats and rabbits to show that its pill's actions on reproduction and other functions were equivale
nt to that of RU-486.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Lader, }{\i supra }{note 248, at 156.}}}{  ARM then submitted a protocol for testing to the FDA.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 156.}}}{
  ARM also had to find a manufacturer to supply the drug for testing of two to three thousand women.  The Westchester lab was not capable to supply the necessary quantities.  Conv
inced that manufacturing must take place over seas due to the violence in the United States, ARM found a British plant to manufacture its drug.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See id.}{ at 155-156.}}}{  In March 1994, Mr. Lader announced, in }{\i The New York Times}{, ARM's testing plan and its hope that testing would begin at the end of the year.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Lader, }{\i RU-486, Made in America}{, }{\i supra }{note 341, at A23.}}}{
\par \tab While Mr. Lader and ARM were hard at work manufacturing a copy of RU-486, Roussel-Uclaf and the Population Council continued negotiations.  Only after then Secretary of Health and Human Services, Dr. Donna Shalala set a May 
15 deadline for concluding the negotiations, did the two companies come to an agreement.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i 
RU-486, Status Report on the U.S. Commercialization Project, Transfer of Anti-Progestin Technology to the United States}{, }{\i supra}{ note 363, at 6 (testimony of Hon. David M. Kessler, M.D., Commissioner, FDA).}}}{
  On May 17, 1994, Roussel-Uclaf announced that an agreement with the Population Council had been reached.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Seelye, }{\i Accord Opens Way}{
, }{\i supra }{note 5.}}}{  According to the agreement, Roussel-Uclaf granted all of the pill's patent rights and technology, for use in the United States, to the Population Council without remuneration.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  In return, Roussel-Uclaf rid itself from any liability from product liability claims.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}}}{  Most likely, Roussel-Uclaf, also, hoped to dista
nce itself from the controversy regarding the pill in the United States and any potential boycotts.  However, it is unlikely that the agreement will serve that purpose.  After Roussel-Uclaf's first meeting with the FDA, one anti-abortion group indicated i
ts intention to boycott Roussel-Uclaf and Hoechst if a marketing application was filed in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Hilts, }{\i Door May Be Open}
{, }{\i supra}{ note 4. }}}{
\par \tab Although it took a long year of negotiations, President Clinton, the Department of Health and Human Services, and the FDA succeeded in their effor
ts to encourage Roussel-Uclaf to help make medical abortion with mifepristone a reality for American women.  A year and a half is actually a relatively small amount of time when considered in light of Roussel-Uclaf's staunch position for the previous five
 years.  Why did Roussel-Uclaf change its tune so quickly?}{\b   }{
As discussed in Part III infra, Roussel-Uclaf had developed a policy for exporting mifepristone; this policy was usually referred to as the five pre-requisites, although Dr. Baulieu indicated and R
oussel-Uclaf confirmed in 1992 that there was a sixth pre-requisite.  Since France began the use of misoprostol in 1991, the United States has met the five re-requisites.  Abortion is legal in the United States and accepted by the majority of society.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  According to a 1998 survey by Hart/Te
eter Research for NBC News/Wall Street Journal, 60% of Americans believe that the choice on abortion should be left up to the woman and her doctor.  }{\i See}{ }{\scaps Ladd}{ & }{\scaps Bowman}{, }{\i supra}{
 note 89, at 22.  However, Roussel-Uclaf could argue that there is too much controversy over abortion, so that this pre-requisite is not actually met.  }{\i See }{Riding, }{\i supra}{
 note 131 (quoting Ms. Mouttet of Roussel-Uclaf who said, in reference to the pre-requisites, "abortion is not an unchallenged right").}}}{  Misoprostol has been available in the United States since the beginning of 1989.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  The FDA announced approval of m
isoprostol to prevent stomach ulcers that plague millions of patients taking drugs prescribed for arthritis on December 27, 1988.  Misoprostol is marketed by G.D. Searle as Cytotec.  }{\i See }{Food and Drug Administration, }{\i Misoprostol Approval }{
(visited Mar. 27, 1999) <http://www.fda.gov/bbs/topics/NES/NEW00142.html>.  Before misoprostol was available, neither of the other prostaglandins, sulprostone or gemeprost, were available in the United States.}}}{
  Tight official control of the drug is possible in the United States.  Finally, women can be required to agree to have a surgical abortion if medical abortion fails.  
\par \tab The United States had not fulfilled the sixth pre-requisite, however.  As discussed earlier in this section, the Reagan and Bush administration were pro-life and instituted anti-abortion policies.  According to a 1993 }{\i New York Times}{
 report, Roussel-Uclaf refused to seek Federal approval for the drug during the Bush administration because of what the company said it felt was an atmosphere hostile to abortion.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Lewin,}{\i  Plans for Abortion Pill, supra }{note 372.}}}{  At a May 16, 1994 congressional hearing regarding the transfer of mifepristone's patent rights to the Pop
ulation Council, a representative of Roussel-Uclaf cited the Reagan-Bush administration's views as one of the reasons that mifepristone was not available in the United States as of that date.  The representative noted that Bush spoke stridently against an
y procedure that would result in the early termination of pregnancy.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i RU
-486, Status Report on the U.S. Commercialization Project, Transfer of Anti-Progestin Technology to the United States}{, }{\i supra}{ note 363, at 16 (testimony of Lester Hyman, Swidler & Berlin, representing Roussel Uclaf).}}}{
  Finally, the representative testified that, "It was only when President Clinton changed the government policy and specifically asked Roussel to make the procedure available, here, that o
ur client, out of respect for the President of the United States, agreed to make every effort to comply with his request."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   Id.}}}{ }{\b  }{
It appears the hidden sixth factor may have been the determinant one regarding mifepristone's future in the United States.}{\b    
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i G.  The Road to Approval}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\b \tab }{
Once Roussel-Uclaf granted the Population Council all United States' patent rights to mifepristone, the Population Council was free to sponsor an NDA for the approval of mifepristone in the United States.  The Population Council, immed
iately, indicated its intention to file an NDA, but said that the NDA would take between nine and sixteen months to prepare.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{
at 11 (testimony of Hon. David M. Kessler, M.D., Commissioner, FDA).}}}{  In May of 1993, the Council had launched a massive effort to plan and prepare for clinical trials, the filing of an NDA for mifep
ristone, the identification of a manufacturer and distributor, and fund-raising to support the expense.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}{
 at 18 (testimony of James S. Boynton, Christy & Viener, representing the Population Council).}}}{  However, since negotiations with Roussel-Uclaf took so long, the Population Council had to put these efforts on hold in the fall of 1993.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ }}}{  Only as the two companies neared agreement did the Population Council recommence its planning phase.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  At the congressional hearing regarding the transfer of mifepristone's patent rights to the Population Council, a representative of the Population Council projected that mifepristone would be on the market in the United States sometime in 1996.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Mr. Boynton said "it would be our hope that it would be possible for the drug to be on the market in the United States sometime in 1996." }{\i  Id. }{
at 18 (testimony of James S. Boynton, Christy & Viener, representing the Population Council).}}}{
\par \tab According to former FDA Commissioner, Dr. Kessler, before the FDA will approve an application for mifepristone, the Population Council has to perform clinical trials in the United States and have a}{\b  }{running manufacturing operation.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ }{\i id.}{ at 11 (testimony of Hon. David M. Kessler, M.D., Commissioner, FDA).}}}{\b   }{
As discussed infra Part I.B, the Population Council began conducting clinical trials in the fall of 1994 at seventeen sites through out the United States.  Finding a manufacturer proved a more difficult task for the Population Council.
\par \tab In the early nineties, only one major American pharmaceutical firm was doing research in female reproduction.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See The Safety
 and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra }{note 97, at 36 (testimony of R. L. MacKenzie, chairman and CEO, Gynopharma, Inc.);  }{\i 
The Effect of Federal Ban of RU 486 on Medical Research, New Drug Development, and Pharmaceutical Manufacturers}{, }{\i supra}{ note 156, at 11 (testimony of Hon. Patricia Schroeder (D-Colo.)).}}}{
  Controversy regarding female reproduction began with oral contraceptives, continued with IUDs, and is alive today.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra }{note 97, at 36 (testimony of R. L. MacKenzie, chairman and CEO, Gynopharma, Inc.).}}}{
  The manufacture of mifepristone is the epitome of such controversy.  Since the introduction of mifepristone in France, anti-abortionists have done their best to stir up such controversy.  As soon as the Population Council and Roussel-Uclaf an
nounced their agreement, anti-abortion groups sent a clear message to American manufacturers repeating their threat that they would boycott whatever American company is chosen to make and market the pill.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Seelye, }{\i Accord Opens Way}{, }{\i supra}{ note 5.}}}{  Businesses avoid such controversy.  In addition t
o loss of public good will, businesses fear internal controversy.  Businesses are concerned that involving themselves in controversy will divide their staff and make the firm less productive in the long run.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kathleen Day, }{\i Protest Fears Spur Effort to Keep Name of Abortion Pill's Maker Secret}{, }{\scaps Wash. Post}{, Sept. 21, 1996, at D1; }{\i 
See The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra }{note 97, at 36 (testimony of R. L. MacKenzie, chairman and CEO, Gynopharma, Inc.).}}}{
  Before involving themselves in such controvers
y, a United States manufacturer would undergo the same profitability analysis, discussed regarding Roussel-Uclaf in Part IV.D.  High research costs, relatively low potential profit, and the enormous risk of liability suits, hardly, made the project more a
ttractive.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kolata, }{\i Any Sale}{, }{\i supra}{
 note 240.  For example, Life Dynamics Inc., a group specializing in finding ways to sue abortion providers for malpractice, sent around a memo asking to be informed of physicians performing chemical abortions and for any inf
ormation about women who deliver handicapped babies subsequent to a failed chemical abortion.  }{\i See}{ Kirschenbaum, }{\i supra}{ note 99, at 124.}}}{ 
\par \tab Experts suggested that the project was more suited for a small pharmaceutical company rather than a large one.  A smaller company would have relatively smaller risks but greater potential reward than a large company.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Kolata, }{\i Any Sale}{, }{\i supra}{ note 240. }}}{  Smaller companies have l
imited product lines.  Therefore, in the event of a liability suit or a boycott, a small company is not putting a large amount of other product lines at risk.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{\i   See}{ Kolata, }{\i Any Sale}{, }{\i supra}{ note 240; Day, }{\i supra }{note 414.}}}{  One small manufacturer, even, suggested that a boycott can be helpful to a small company.  Unli
ke a large company, the manufacturer suggested that a boycott will not damage a small company's reputation, but that a small company will thrive on the publicity.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   See The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra }{
note 97, at 36 (testimony of R. L. MacKenzie, chairman and CEO, Gynopharma, Inc.).}}}{  Also, estimated profits might be trivial to a large company, compared with its other products, but such profits could be large for a smaller company.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kolata, }{\i Any Sale}{, }{\i supra}{ note 240.}}}{
  Finally, a smaller company may be able to avoid internal controversy, due to the limited number of employees and the company's clear purpose.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets:  Opportunities and Obstacles to U.S. Commercialization}{, }{\i supra }{note 97, at 36 (testimony of R. L. MacKenzie, chairman and CEO, Gynopharma, Inc.).}}}{    
\par \tab A growing concern for both large and small manufacturers, however, was the increasing violence surrounding abortion.  In the early 1980s, Operation Rescue began picketing abortion clinics and providing sidewalk counseling to visitors of such clinics.
}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Schaff, }{\i supra}{ note 101, at 314.}}}{  However, things quickly changed from peaceful to v
iolent.  In 1982, members of a group known as the Army of God kidnapped an Illinois abortion doctor and his wife.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 315.}}}{
  In 1984, the Army of God sent a threatening letter to Supreme Court Justice Harry Blackmun, author of }{\i Roe v. Wade}{, and in 1985, a bullet shattered a window in his home.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  In 1993, the first abortion provider killing occurred.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 316.}}}{
  Dr. David Gunn was shot to death in front of the Pensacola, Florida clinic where he performed abortions.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{
  One anti-abortion leader responded to his death with the following statement:  "This shooting, while unfortunate, will result in babies['] lives being saved."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  Seth Faison, }{\i Abortion Doctor Wounded Outside Kansas Clinic}{, }{\scaps N.Y. Times}{, Aug. 20, 1993, at A12.}}}{  
\par \tab In 1994, the Freedom of Access to Clinic Entrances Act, FACE, was passed.  FACE, having outlawed peaceful strategies utilized by Operation Rescue}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  FACE prohibits the use of force, threat of force, or physical obstruction to intentionally injury, intimidate, or interfere with any person obtaining or providing reproductive Health Services.  }{\i See}{
 Freedom of Access to Clinic Entrances Act, 18 U.S.C.A. \'a7 248(a)(1)  (West Supp. 1999).  FACE defines physical obstruction to mean rendering impassable ingress or egress from a facility that provides reproductive health services.  }{\i See }{
18 U.S.C.A. \'a7 248(e)(4) (West Supp. 1999).}}}{, grounded such operations to a halt and violence steadily increased.  As of November 1998, 15 attempted murders had been recorded since 1991.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Jennifer Gonnerman, }{\i The Village Voice: The Terrorist Campaign Against Abortion}{ (visited Feb. 9, 2000) <http://www.villagevoice.com/features/9845/gonnerman.shtml>.}}}{
  A web site called the "Nuremberg Files", listing doctors and clinic workers, was created to provide information for those wishing to organize in their community.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ Schaff, }{\i supra}{ note 101, at 316.}}}{  Critics insist that the true intention of the web site is to create a hit list; one doctor's name was crossed off the web site after his murder.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See }{Gonnerman, }{\i supra}{ note 427.}}}{  The pool of people endangered has quickly widened and their zone of safety has decreased.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{  In 1994, an abortion doctor and his escort were shot to death.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See}{ }{\scaps Lader}{, }{\i supra }{note 248, at 187.}}}{  In December of 1994, John Salvi III went on a shooting spree in two Boston clinics; Salvi killed a receptionist and another clinic worker and injured five other pe
ople, including visitors.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Zitner, }{\i supra}{ note 84; }{\scaps Lader}{, }{\i supra}{ note 248, at 215.}}}{
  In 1998, an abortion doctor was killed by a sniper in his own home.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Gonnerman, }{\i supra }{note 428.}}}{
\par \tab Some of the violence has been shown to be directly related to the use of mifepristone. The December 1994 shooting by John Salvi occurred at a clinic participating in the Population Council's clinical trials and distributing mifepristone.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Carolyn Ryan, }{\i Clinic Stops Distributing Abortion Pill Brookline Killings Prompt Move}{, }{\scaps Patriot Ledger}{
 (Quincy, Mass.), Jan. 31, 1995, at 26.}}}{  In November of 1994, the clinic had made a public announcement that it would make the drug available.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{
\i See id.}}}{  On November 12, protesters demonstrated outside the clinic.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  On that 
fateful day in December, the clinic's receptionist was killed and three others injured.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  In response, the clinic stopped making the drug available.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{     
\par }{\b \tab }{In response to fear of violence, as well as boycott threats, the FDA and the Population Council have made an unprecedented agreement to bring the pill to market with the manufacturer's name remaining secret.}{\b  }{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Day, }{\i supra}{ note 414.  }{\i See generally}{ Schaff, }{\i supra}{ n
ote 101 (discussing how violence has frightened away potential manufacturers of mifepristone).}}}{  Even with the promise of secrecy, major pharmaceutical firms were not "rushing in to do this [manufacture mifepristone]", according to Council pr
esident, Margaret Catley-Carlson.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Carlyle Murphy and Kathleen Day, }{\i 
Abortion Pill's U.S. Debut Snagged by Business Dispute; Sponsor Seeks to Oust Associate for not Disclosing Disbarment}{, }{\scaps Wash. Post}{, Jan. 12, 1997, at A1.}}}{
  Perhaps, manufacturers worried that it would be impossible to keep the manufacturer hidden.  Anti-abortion groups believe that once mifepristone becomes a drug on the market that the information will reach their groups.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Kirschenbaum, }{\i supra}{ note 99, at 124.}}}{
  Paul Schenk, a minister who helped organize Operation Rescue, is confident that informants will come forward be it from production, marketing, or the delivery system.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}}}{  
\par \tab Since the pharmaceutical firms that the Council approached were not interested, Population Council officials requested proposals.  According to President Catley-Carlson, the Council received five proposals.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Murphy and Day, }{\i supra}{ note 441.}}}{  Amongst those willing to help the Council were Mr. Lader and ARM.  Mr. Lader met with President Catley-Carlson on June 24, 1994 an
d offered the Council use of ARM's British plant.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{\i\scaps  }{\scaps Lader}{, }{\i supra }{note 248, at 158.}}}{
  Mr. Lader assured Ms. Catley-Carlson that the British plant would minimize costs and that it could ensure security, due to the country's intolerance of anti-abortion furor.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }}}{  According to Mr. Lader, Ms. C
atley-Carlson listened politely, but he received the distinct impression that the Council planned to spend a significant amount of time interviewing potential manufacturers and sources of funding.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 159.}}}{  Mr. Lader did, however, convince the Council to consider ARM's British plant.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id. }}}{  In July, ARM and the Population Council signed a mutual secrecy agreement and ARM gave the Council all of its documents and contracts regarding the plant.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }}}{
\par \tab Since the Population Council appeared to be moving slow and after the November 1994 election, the majority of congress was pro-life, ARM began to vigorously pursue its plan to test its copy of mifepristone on 2000 to 3000 women.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 160. }}}{  On March 14, 1996, the }{\i San Francisco Chronicle}{ announced that ARM had filed a request with the FDA to begin tests of its pill.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Sabin Russell, }{\i Abortion-Rights Group Asks to Test RU-486 Copy/UCSF Scientists also Trying Another Version of Pill}{, }{\scaps 
S.F. Chron.}{, Mar. 14, 1996, at A3.}}}{  In addition, the chronicle announced the testing of methotrexate, a drug used to treat cancer patients, as an abortifacient.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.  }{Methotrexate blocks the use of folic acid, a vitamin needed by the rapidly growing fetal cells, and thus causes fetal death. }{\i  See}{\scaps  Lader}{, }{\i supra}{ note 248, at 208.}}}{
  Methotrexate has been available in the United States since 1954; therefore, doctors could administer it as an abortifacient at their discretion.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{
\i See }{Lakomy, }{\i supra}{ note 103, at 51; 37 Fed. Reg. \'b6 16,503; 52 Fed. Reg. \'b6 8802-8803.}}}{  The disclosure of these two studies was designed to put pressure on the Population Council.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Russell, }{\i supra}{ note 451.}}}{
\par \tab Four days later, on March 18, 1996, the FDA received an NDA from the Population Council for the use of mifepristone in combination with misoprostol.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{ }{\i  See}{ Advisory Committee, }{\i supra}{ note 21, at 4 (testimony of David A. Kessler, M.D.); Food and Drug Administration, }{\i FDA Issued Approvable Letter for Mifepristone}{
, Sept. 18, 1996 (visited Mar. 27, 2000) <http://www.fda.gov/bbs/topics/answers/ans00758.html>.}}}{  The FDA accepted the application on the basis of foreign clinical data in the form of two large clinical trials conducted in France.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Advisory Committee, }{\i supra }{note 21, at 5 (testimony of David A. Kessler, M.D.
).  The FDA accepts foreign clinical studies not conducted under an IND if the studies are "well designed, well conducted, performed by qualified investigators, and conducted in accordance with ethical principles acceptable to the world community."  21 C.
F.R. \'a7 312.120(a) (1999).  In certain circumstances, the FDA may approve an application based solely on foreign clinical data.  }{\i See}{ 21 C.F.R. \'a7 314.106(b) (1999).  }}}{
  The FDA accepted the application with the understanding that the Population Council would, during the course of the FDA's review of the application, submit data from its United States clinical trial.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Advisory Committee, }{\i supra}{ note 21, at 5 (testimony of David A. Kessler, M.D.).}}}{
\par \tab On July 19, 1996, the Reproductive Health Drug Advisory Committee of the Center for Drug Evaluation and Research convened to review the data
 from the clinical trials of mifepristone as an abortifacient and provide a recommendation to the FDA on the safety and effectiveness of the drug for its intended use.  The Committee heard from representatives of the Population Council and the FDA regardi
ng the safety and effectiveness of mifepristone and misoprostol for medical abortion and the acceptability of the regimen to women.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{
 at 21-94,121-44 (testimony of Irving M. Spitz, M.D., C. Wayne Bardin, M.D., Beverly Winikoff, M.D., Ridgley C. Bennett, M.D., and Lisa Rarick, M.D.).  Also see discussion infra Part I.B and II.B regarding the safety and effectiveness of mifepristone a
nd the acceptability of the regimen to women.  }}}{  After hearing such testimony, the Committee agreed, with a vote of 6 for and 2 abstentions, that taking into consideration 
the overall evidence for safety and effectiveness of the regimen, that the benefits outweigh the risks for the use of the regimen for medical abortion in the United States.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid 
{\cs16\super \chftn }{\i   See }{Advisory Committee, }{\i supra }{note 21, at 298.}}}{  The committee recommendation was not binding on the FDA, but the FDA is said to consider committee recommendations very carefully.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See CDER Handbook}{, }{\i supra}{ note 166.}}}{
  The committee noted the lack of the final United States clinical data in their review and requested an opportunity to review such data, if it is significantly different than the French data.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  See Advisory Committee, }{\i supra}{ note 21, at 282.}}}{
\par \tab The committ
ee also commented on the proposed labeling and distribution of the drug.  The committee had two concerns regarding the proposed labeling.  First, the committee believed that the cautions, conditions, and exclusions, included in the trial protocol, should 
be included in the labeling and patient information leaflets with a warning that there is no data as to what the effects would be with these associated conditions.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See }{Advisory Committee, }{\i supra}{ note 21, at 306.}}}{  For example, the French clinical trials excluded women who were over 35 and smokers.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}{ at 44 (testimony of Irving M. Spitz, M.D.).}}}{  Seco
nd, the committee recommended that the information regarding surgical termination, in the event of failure of the medical abortion, should make it clear that, although the risk is unknown, there is a risk to the fetus.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{at 306.}}}{  Regarding distribution of the drug, the committee exhibited "considerable unease".}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id. }{at 324.}}}{  According to the NDA, the drug will be provided directly to providers and will not be sold in pharmacies.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id. }{at 81 (testimony of Beverly Winikoff, M.D.).}}}{  It will be provided only to physicians who have training in the dating of pregnancy, the diagnosis
 of ectopic pregnancy, and how to do a surgical abortion and who have access to facilities for surgical abortion and for emergency treatment of any complications.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id. }{at 81, 317.}}}{  Physicians will be required to supervise administration and records must be kept for each dose used.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See id. }{at 81 (testimony of Beverly Winikoff, M.D.).}}}{
  These precautions are to be taken in order to make sure that the drug is provided as safely as it has been in clinical trials and other countries, such as Britain and France.  The committee agreed with the concept of the proposed distribution, 
but questioned its feasibility in practice and more specifically how the Population Council and the manufacturer were going to ensure adequate training of providers.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id. }{at 325.}}}{         
\par \tab After the advisory committee meeting, FDA Commissioner, Dr. Kessler, indicated that the FDA intended to act on the Population Council's NDA within the six month user fee deadline of September 18, 1996.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  The Prescription Drug User Fee Act of 1992 says that the FDA should act on priority applications within six months.  }{\i See}{ }{\i 
FDA Deadline for Mifepristone Decision is Sept. 18; Efficacy of Mifepristone for Pregnancy Termination Established by Two French Studies Cmte Says}{, }{\scaps The Pink Sheet}{, July 22, 1996, at 3.  This deadline is also in accordance with 21 U.S.C. \'a7
 355(n) (1999), which requires the FDA to make a final decision within 90 days of a scientific advisory panel's recommendation.}}}{
  Advocates of mifepristone hoped that the FDA would be true to its word due to the upcoming Presidential election; opponents felt th
at the FDA was rushing a decision in fear that Clinton may not be re-elected.  True to its word, on September 18, 1996, the FDA issued an approvable letter for mifepristone in combination with misoprostol for early medical abortion.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Food and Drug Administration, }{\i FDA Issued Approvable Letter for Mifepristone}{, }{\i supra}{ note 455; Population Council, }{\i 
FDA Issues Approvable Letter for Mifepristone Medical Abortion,}{ Sept. 18. 1996}{\i  }{(visited Jan. 6, 2000) <http://www.popcouncil.org/news%5Fviews/approvable.html>.}}}{  According to the lett
er, the agency determined that substantial clinical data demonstrated the safety and efficacy of mifepristone, in combination with misoprostol, when used under medical supervision.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Food and Drug Administration, }{\i FDA Issued Approvable Letter for Mifepristone}{, }{\i supra}{ note 455; Population Council, }{\i FDA Issues Approvable Letter for Mifepristone Medical Abortion, supra}{
 note 471}{\i .}}}{  As discussed infra Part IV.A, an approvable letter is an action frequentl
y used by the FDA to indicate that safety and efficacy data have passed agency review, but that additional information must be submitted before the FDA can grant final approval for marketing.  The FDA indicated that additional information on other issues,
 including the manufacturing process and labeling, must be submitted before the FDA can make a final decision.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Food and Drug Administration, }{\i FDA Issued Approvable Letter for Mifepristone, supra}{ note 455}{\i ; }{Population Council, }{\i FDA Issues Approvable Letter for Mifepristone Medical Abortion, supra}{ note 471. }}}{
  Most likely, the FDA has similar concerns to those of the advisory committee regarding labeling and distribution.  Also, the FDA cannot approve 
a drug for marketing unless the sponsor has proven that the drug can be appropriately manufactured.  As of September 1996, the Population Council said they had found a manufacturer,}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Day, }{\i supra}{ note 414.}}}{ but it is likely the manufacturing process itself was not complete and operational.  
\par \tab Normally, approvable letters are answered within ten days, and shortly thereafter, an approval letter is issued.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Tamar Lewin, }{\i 
Lawsuits' Settlement Brings New Hope for Abortion Pill}{, }{\scaps N.Y. Times}{, Nov. 13, 1997, at A14 [hereinafter Lewin, }{\i Lawsuits' Settlement}{]; 21 C.F.R. \'a7 314.110 (1999) (requiring response, to approvable letter, by applicant within 10 days).
}}}{  Yet over three years later, an approval letter has still not been issued for mifepristone, in combination with misoprostol, for use as an abortifacient.  What happened?
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i H.  Legal Pitfalls
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\b \tab }{The first sign of trouble was in November of 1996.  On November 4, 1996, the Population Council filed suit against Joseph D. Pike.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Tamar Lewin, }{\i Dispute May Delay Abortion Drug in U.S.}{, }{\scaps N.Y. Times}{, Nov. 6, 1996, at A16 [hereinafter Lewin, }{\i Dispute May Delay}{
].  Advances in Health Technology, AHT, filed suit also.  }{\i See id.}}}{  Mr. Pike was one of the five, whom submitted a proposal to th
e Population Council for the distribution and manufacture of mifepristone.  Mr. Pike had a prior relationship with the Council, having worked with it in the effort to bring the copper-T intrauterine, another product shunned by large manufacturers, to the 
American market.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Tamar Lewin, }{\i Abortion Pill's Legal Woe May Be Nearing an End}{, }{\scaps N.Y. Times}{, Jan. 25, 1997, \'a7
1, at 5 [hereinafter Lewin, }{\i Abortion Pill's Legal Woe}{].}}}{  President Catley-Carlson said that the prior business relationship was a "deciding factor" in choosing Mr. Pike for the mifepristone project.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Murphy and Day, }{\i supra}{ note 441.}}}{  President Catley-Carlson also said that the Council was attracted to Mr. Pike's proposal becau
se it suggested setting up a nonprofit group called Advances in Health Technology, AHT.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  Under the proposal, AHT would be separate from the Council and handle highly visible educational programs and deal with what President Catley-Carlson called the "public defense" of mifepristone.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Id.}}}{  }{\b 
\par \tab }{Having accepted Mr. Pike's proposal, the plan was set into action.  AHT was created as a separate entity in July of 1995.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 James A. Miller, }{\i Revealing Lawsuits Delay RU-486 Deployment }{(visited Jan. 6, 2000) <http://www.hli.org/publications/hlir/1997/hr029701.html>.}}}{  In December of 1995, AHT was licensed by the Council to market mifepristone.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Murphy and Day, }{\i supra}{ note 441.}}}{  AHT then immediately sub-licensed the marketing rights to Mr. Pike as previously agreed to by all three parties.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  AHT was publicly identified as the licensee, but Mr. Pike was not.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id. }{ Mr. Pike was not publicly identified until the lawsuit was filed.  }{\i See id.}}}{
  Under the December 1995 contract, Mr. Pike was to set up a company to receive the raw mifepristone from the manufacturer, which was already chosen by the Council but not identified, and then package and distribute the pills.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  Another company was to test and market the mifepristone for potential uses other than early abortion.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  Both companies were to pay royalties and licensing fees to both the Council and AHT and keep the profits.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  Mr. Pike set up a network of interlocking companies in California.  Danco Laboratories was created to handle the marketing and distribution of mifepristone as an abo
rtifacient.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Miller, }{\i supra}{ note 481; Lewin, }{\i Dispute May Delay}{, }{\i supra}{ note 476.}}}{
  NeoGen Pharmaceuticals was created to test and market mifepristone for other medical indications.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Miller, }{\i supra}{ note 481.}}}{
  NeoGen Holdings, another company created by Mr. Pike, ultimately controlled these two entities.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  It was Mr. Pike's job to raise money from investors to finance the mifepristone project.  Mr. Pike created NeoGen Investors, a California limited partnership.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}}}{  Mr. Pike then set out to raise money by the sale of private placement limited partnership units in NeoGen Investors.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See id.}}}{ 
\par \tab The Population Council's suit charges Mr. Pike with fraud and seeks to have his interest in the drug transferred to a receiver.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Lewin, }{\i Dispute May Delay}{, }{\i supra }{note 481.}}}{  In 1993, Mr. Pike pleaded guilty to a misdemeanor forgery change in a 1985 North Carolina real estate deal, where he falsely inflated the cost of a piece of property to two investors.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Murphy and Day, }{\i supra}{ note 441; Lewin, }{\i Dispute May Delay}{, }{\i supra}{ note 476.}}}{  Mr. Pike was subsequently disbarred.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  See Murphy and Day, }{\i supra}{ note 441; Lewin, }{\i Dispute May Delay}{, }{\i supra}{ note 476.}}}{
  Mr. Pike's legal problems were first brought to the attention of the Population Council by an investor in the project.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Murphy and Day, }
{\i supra }{note 441.}}}{  When questioned, Mr. Pike said it was a different Joseph D. Pike.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  Mr. Pike's spokesman said that he called the Council twenty-four hours later to say that he had been disbarred.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{
  President Catley-Carlson said that she did not learn the truth for a few weeks.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{  Having become aware of Mr. Pike's legal problem
s, the Council began negotiations to have him withdraw from the venture.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ David R. Olmos, }{\i 
Abortion Pill Maker Denies Suit Charges; Litigation:  NeoGen of San Diego Says It Didn't Try to Conceal the Criminal Records of Its Chief Partner}{, }{\scaps L.A. Times}{, Nov. 6, 1996, at D2.}}}{  When he refused, the Council filed suit.  
\par \tab The complaint states that Mr. Pike's fraud imperils the mifepristone project.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Lewin, }{\i Dispute May Delay}{, }{\i supra }{note 476.
}}}{  It states that unless Mr. Pike is expeditiously removed, it will be much more difficult, if not impossible, to raise the additional funds that are still needed to fund the project.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  The Council also feared that Mr. Pike's legal problems provided another weapon, to ideological opponents, with which to attack the project.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  The complaint also alleges that Mr. Pike has not accounted for all the money invested.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{  In mid-1996, Mr. Pike represented to the Council that he had raised approximately $14 million through the sale of limited partnership units.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Miller, }{\i supra }{note 481.}}}{  The Council 
asserted that as of the end of July 1996, $1.6 million of the proceeds of such offering were being held by NeoGen Industries, an entity of which the Council had never before heard and whose name had been changed by Mr. Pike four times.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  At that time, the Council was unclear what happened to the other $12.4 million.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  The Council sought injunctive relief and did not sue on the contract, which implies that Mr. Pike did not breach the terms of the contract.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{  
\par \tab Mr. Pike moved to dismiss the Council claims.  However, U.S. District Judge Sonia Sotomayer rejected Mr. Pike's motion and set trial for March 31, 1997 on the issue of whether Mr. Pike defrauded the Council by not disclosing his disbarment.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Murphy and Day, }{\i supra }{note 441.}}}{  Meanwhile, the mifepristone project was at a standstill, the 
Population Council having refused to move forward with the project until Mr. Pike sold his holdings.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Lewin,}{\i  Lawsuits' Settlement}{, }
{\i supra }{note 475.}}}{  In February of 1997, the Population Council and Mr. Pike reached a settlement and avoided going to trial.  Under the settlement, Mr. Pike agreed to sell 
a substantial portion of the equity in the marketing venture to existing investors.  According to the Council, Mr. Pike "retains a modest, although passive, equity interest" in the project, but has signed documents agreeing not to reinsert himself into th
e project in any managerial capacity.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Population Council, }{\i Mifepristone: Litigation Settled:  A New Company
 Is Formed to Take Control of Project in the U.S.}{, Feb. 12, 1997 (visited Jan. 6, 2000) <http://www.popcouncil.org/news%5Fviews/newcompany.html>; Caryle Murphy, }{\i Abortion Pill Accord Clears Way for Sales}{, }{\scaps Wash. Post}{
, Feb. 13, 1997, at A1.}}}{  According to a }{\i New York Times}{ report, Mr. Pike retains a 25% interest.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Lewin,}{\i  Lawsuits' Settlement}
{, }{\i supra }{note 475.}}}{  
\par \tab Also, under the settlement, a new company, Advances for Choice, was created; AHT was folded into Advances for Choice.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{
Population Council, }{\i Mifepristone: Litigation Settled:  A New Company Is Formed to Take Control of Project in the U.S.}{, }{\i supra }{note 511.}}}{  The Population Council
 announced that Advances for Choice would be run by Jack Van Hulst, a pharmaceutical executive who has experience in turning around manufacturing facilities.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{ }{\i See}{ }{\i Mifepristone (RU-486) Distribution to Be Headed by Former Generic Exec Van Hulst}{, }{\scaps The Pink Sheet}{, Feb. 17, 1997 at T&G-7.}}}{  Shortly thereafter, Advances for Choice underwent a name change to Advances/Neogen.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ James A. Miller, }{\i RU-486 Lawsuits: Chapter Two}{ (visited Jan. 6, 2000) <http://www.hli.org/publications/hlir/1997/hr089709.html>. }}}{
  In June of 1997, Mr. Van Hulst's relationship with Advances/Neogen was unclear; Advances/Neogen said that Mr. Van Hulst's relationship with the company may be changing; the Population Council said that Mr. Van Hulst was now serving as a consultant.}{
\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See Richter Exit From RU-486 Bulk Supply Agreement Could Jeopardize Danco Patent Rights}{, }{\scaps The Pink Sheet}{, June 16, 1997 [hereinafter}
{\i  Richter Exit}{].}}}{  In July of 1997, }{\i The New York Times}{ reported that Mr. Van Hulst was no longer the chief executive and a new leader would be named.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ Tamar Lewin, }{\i Group Is Intensifying Its Campaign to Distribute Abortion Pill}{, }{\scaps N.Y. Times}{, July 2, 1997, at A21 [hereinafter Lewin, }{\i Group Is Intensifying}{].}}}{
  Mr. Van Hulst's removal was yet another sign of potential problems.
\par \tab The Population Council faced other legal trouble in November of 1996.
  Giant Group, a Los Angeles investment group, signed an agreement with Mr. Pike on July 24, 1996, where Mr. Pike agreed to negotiate exclusively with the Giant Group until September 30, 1996.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Lewin, }{\i Dispute May Delay}{, }{\i supra}{ note 476.}}}{  Giant Group wished to invest $6 million in return for a 26% share of the mifepristone project.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Lewin, }{\i Lawsuits' Settlement}{, }{\i supra }{note 475.}}}{
  The Giant Group and Mr. Pike never reached an agreement.  According to Mr. Pike, Giant never submitted a presentable offer.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Olmos, }{\i 
supra }{note 500.}}}{  Also, Mr. Pike discovered that Mr. Sugarman, the head of Giant Group, agreed to pay $619,000 to settle securities charges arising from his takeover of a fast food chain.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Lewin, }{\i Dispute May Delay}{, supra note 476.}}}{
  In October of 1996, Giant filed fraud charges against Mr. Pike and the Population Council, accusing Mr. Pike of concealing his past legal and professional problems.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{ }{\i  See}{ Lewin, }{\i Lawsuits' Settlement}{, supra note 475.}}}{  In November of 1997, Giant Group settled the suit with the Population Council.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}}}{  
\par \tab Another business dispute plagued the mifepristone project in early 1997.  In February, Gedeon Richter, a Hungarian manufacturer, informed the Population Council that it was terminating
 the manufacturing agreement entered into by the companies in 1995.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See Richter Exit, supra}{ note 516. }}}{
  Under the agreement, Gedeon Richter agreed to manufacture all of Danco Laboratories requirements for bulk mifepristone in the United States, for at least five years.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{\i   See id.}}}{  A separate manufacturer, yet to be named, would put mifepristone into tablet form.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  In addition, Gedeon Richter agreed to create pilot scale batches and to file a drug master file with the FDA.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{
  Gedeon Richter would replace Roussel-Uclaf as the manufacturer on the Population Council's NDA submission.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  According to the approvable letter, issued on September 18, 1996, the FDA would merely require Gedeon Richter to demonstrate, through submission of its own drug master file, the comparability of its manufacturing processes a
nd the bulk drug substances it produces to those of Roussel-Uclaf.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{
  On January 18, Gedeon Richter told the Council that its drug master file was ready for submission.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  In mid-February, two days after the Population Council told Gedeon Richter that it wou
ld need to ship material for the trial batch to the FDA within the next few weeks, Gedeon Richter informed the Population Council of its intention to terminate the contract.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{ }{\i  See id.}}}{    
\par \tab After months of negotiating, Danco Laboratories filed suit on May 9 in New York Supreme Court alleging breach of contract by Gedeon Richter.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{
\i See}{ Caryle Murphy, }{\i Abortion Pill's U.S. Sponsor Suing Hungarian Drug Firm}{, }{\scaps Wash. Post}{, June 12, 1997, at A3 [hereinafter Murphy, }{\i Abortion Pill's U.S. Sponsor}{]}}}{
  The lawsuit states that Danco and the Council are having great difficulty finding another manufacturer and even if they did, that the project is likely to be delayed 3 to 5 years.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  The suit also states that Gedeon Richter's breach of contract could cause financial losses in excess of $200 million.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See id.}}}{  Sandra Waldman, director of public information at the Population Council, said, "what's laid out in the court papers is the worst-case scenario."}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i Id.}}}{
  She emphasized that Gedeon Richter, Danco, and the Population Council were continuing to negotiate as of June 1997 and that meanwhile, Danco was actively looking for new manufacturers.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Caryle Murphy, }{\i Abortion Pill Dispute May Delay Debut; U.S. Sponsor Losing European Supplier}{, }{\scaps Wash. Post}{, June 11, 1997, at A1.}}}{
  As of March 2000, Ms. Waldman was unwilling to comment on the status of this litigation.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  Electronic Mail, dated Feb. 24, 2000, from Sandra Waldman, Director, Public Information, Population Council to author, responding to author's questions regarding mifepristone. }}}{
\par \tab The Population Council's legal and business disputes prompted questions regarding its business judgment.  There is no question that the Population Council should be criticized for failing to review Mr. Pike's background before li
censing him the market rights to mifepristone.  Due diligence is a routine step performed before entering business transactions.  Their, Mr. Pike's and the Population Council's, business relationship, is no defense for the failure to perform due diligence
.
  Moreover, some also question the choice of Mr. Pike's proposal, arguing that the proposal was too complex and that he is not a professional.  As to the former, the Population Council may not have had much choice.  According to reports, no major pharmace
utical company was willing to touch the project.  Johnson & Johnson, Schering-Plough, Pharmacia & Upjohn, and Pfizer have all indicated that they will not get involved with the project.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See, e.g., }{Laura Fraser, }{\i The Abortion Pill's Grim Progress}{, }{\scaps Mother Jones}{, Jan. 1, 1999, at A1.}}}{
  As for the latter, a Council staffer at the time reported that the mifepristone project did attract a fair number of venture capitalists, but that they all seemed sleazy to the Council.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See}{ Kirschenbaum, }{\i supra}{ note 99, at 115.}}}{
  The staffer said that Mr. Pike, whom the Council had worked with before and was recommended by Forrest Greenslade, a former consultant to the Council, looked pretty good in comparison.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  
\par \tab Gloria Feldt, president of the Planned Parenthood Federation of America, believes that the major pharmaceutical companies' unwillingness to be involved with the project, as a result of anti-abortion politics, caused the unusual business arrangement.}
{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Lewin, }{\i Abortion Pill's Legal Woe}{, }{\i supra }{note 477.}}}{
  The Council, agreeing that the arrangement was unusually complex and secretive, also cites abortion politics as the cause.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Murphy and Day, }{\i supra }{note 441.}}}{  The Council insists that secrecy was necessary due to the violent nature of politics.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{
  Nevertheless, the Council should not have allowed the confidentiality surrounding the project to prevent it from being aware and advised of Mr. Pike's arrangement.  The Population Council's failure to continually supervise the project again indicates 
a lack of business judgment.
\par \tab As well as affecting business relations, the secrecy surrounding the project and the Population Council's refusal to provide key details regarding the project have also fueled the anti-abortion groups' campaign.  Gracie Hsu, a
 policy analyst with the Family Research Council, argues, "Women ought to be aware of who will manufacture the drug, who is behind it, and what the track records of those people are."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{ }{\i  Id. }{ }{\i See}{ Kirschenbaum, }{\i supra}{ note 99, at 125.  }}}{  The Family Research Council also insists that it is imperative that wo
men be able to hold the company accountable; the Family Research Council fears that such secrecy jeopardizes the safety of women's health.}{\cs16\super \chftn {\footnote \pard\plain \s18\sl240\slmult0\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn 
}{  }{\i See}{ Zitner,}{\i  supra}{ note 84; Kirschenbaum, }{\i supra}{ note 99, at 125.  The FDA will require information about the drug be included on the label and women will have standard recourse for liability claims. }{\i   See }{
Kirschenbaum, at 125. }}}{         
\par \tab As of November 1997, a little over a year after the introduction of mifepristone had appeared so imminent,
 mifepristone was no closer to being introduced in the United States.  If anything, the prospects for mifepristone's future in the United States were more dismal.   The mifepristone project had spawned at least seven lawsuits.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Zitner, }{\i supra }{note 84.  Other lawsuits include the filing of lawsuits by investors and potential investors against Mr. Pike and by an employee
 for nonpayment of wages.  }{\i See id.}}}{  Danco Laboratories and the Population Council had failed to find a new manufacturer.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See }{Lewin, }
{\i Lawsuits' Settlement}{, }{\i supra }{note 475.}}}{  The project was often strapped for cash.  In addition to the added expenses, investor relations had deteriorated.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  When control passed from Mr. Pike to three general partners, others who invested in the deal were promised an option to get their money back, but no recission offer w
as made; investors said when they wrote or called the general partners their letters and calls were not returned. }{\i See id.}}}{  Far after the usual response time of ten days, the Council had still failed to s
ubmit all the information requested by the FDA in its approvable letter.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Murphy, }{\i Abortion Pill's U.S. Sponsor}{, }{\i supra}{
 note 532.}}}{ 
\par }\pard \qj\sl600\slmult0\widctlpar\adjustright {\i I.  Recent Developments}{
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab After Gedeon Richter's termination of its contract with Danco Laboratories, Danco had to begin the unenviable task of finding a manufacturer once again.  Th
e anti-abortionists had not stopped their efforts.  Anti-abortionists continued to threaten manufacturers with the fear of a boycott.  In April of 1997, the NRLC announced a boycott of Allegra, a Hoechst antihistamine, in response to Roussel-Uclaf and Hoe
chst's agreement to grant the rights to mifepristone to Dr. Sazik, president of Roussel-Uclaf.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Julie Rovner, }{\i 
US Antiabortionists Boycott Allergy Drug}{, }{\scaps The Lancet}{, April 12, 1997 at 1079; Joseph Schuman, }{\i Fearing U.S. Boycotts, Hoechst Gives Away World Rights to Abortion Pill}{, }{\caps A}{ssociated Press, Apr. 8, 1997.}}}{
  The boycott, announced in full-page advertisements in USA Today and other publications}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Rovner, }{\i supra}{ note 550.}}}{
, sent a clear message to manufacturers that the 'NRLC means business'.  Anti-abortion violence continued.  In February of 1998, the Army of God planted a bomb at a women's clinic in Birmingham, Alabama.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ }{\i 'Army of God' Claims It Bombed Alabama Clinic}{, }{\scaps Wash. Post}{, Feb. 3, 1998, at A5.}}}{
  The group then sent a letter to Reuters claiming responsibility for the bomb and threatening additional bombings directed at manufacturers and distributors of  mifepristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See id.}}}{  Finally, several mutual funds with anti-abortion agenda have said that they will exclude manufacturers of mifepristone from their portfolios.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Fraser, }{\i supra }{note 538.}}}{  Aquinas President, Frank Rauscher, wrote to drug companies 
whose stock he owned, pointing out the litigation risk to any firm that manufactured or distributed mifepristone and indicated he would drop a company that got involved.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ Associated Press, }{\i House Votes to Halt FDA Approval of RU-486 Abortion Opponents Claim Victory Over Pill}{, }{\scaps Chicago Trib}{., June 18, 1998, at 12.}}}{
  Mr. Rauscher claims that Merck, Johnson & Johnson, Schering-Plough, Pharmacia & Upjohn, and Pfizer have indicated to him that they will not get involved.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{\i   See}{ Fraser, }{\i supra}{ note 538.}}}{  Although hiding under the guise of product liability concerns, Mr. Rauscher was primarily motivated by ethical concerns.
\par \tab Within Congress there has also been efforts to block the intro
duction of mifepristone into the United States.  In both 1998 and 1999, Congressman Tom Coburn (R-Okla.) introduced an amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Act to block approval 
o
f the drug by the FDA.  The amendment stated that "none of the funds appropriated or otherwise made available by this Act may be used by the Food and Drug Administration for the testing, development, or approval (Including approval of production, manufact
uring, or distribution) of any drug for the chemical inducement of abortion."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  H.R. 1906, 106 Cong. (1999); 145 Cong. Rec. H. 3780 (1999).  }{\i 
See also}{ H.R. 4101, 105 Cong. (1998); 144 Cong. Rec. H. 5075.  The 1998 amendment is identical to the 1999 amendment quoted above except that the phrase "appropriate or otherwise" is excluded.}}}{
  There was much discussion, on the House floor, regarding the consequences of such an amendment.  Mr. Coburn argued that the purpose of the amendment is to limit the FDA's abilit
y to approve any drug that has its sole purpose, its listed intended use, to eliminate and terminate an unborn child.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ 145 Cong. Rec. H 
3780; 144 Cong. Rec. H. 5075.}}}{  Other congress members asserted that FDA lawyers indicate that the amendment will prevent the FDA from dealing with any drug that is brought to them for approval that may have the consequence of terminating a pregnancy.}
{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ 145 Cong. Rec. H. 3780.}}}{
  For example, according to the FDA lawyers, the amendment would have prevented the approval of methotrexate, which is used to treat cancer patients but also can be used to
 terminate pregnancy. After much discussion, the House voted to adopt the amendment in 1998, with a vote of 223-202, and in 1999, with a vote of 217-214.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See}{ }{\i House Votes to Halt FDA Approval of RU-486, Abortion Opponents Claim Victory Over Pill}{, }{\scaps Chicago Trib}{., June 25, 1998, at 12; 145 Cong. Rec. H. 3780.}}}{
  The Senate never voted on the issue; in both years, the amendment died during conference.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ J.M. Lawrence, }{\i RU-486 Delays Enr
aging Feminists; 'Abortion Pill' Debate Reaching Fever Pitch}{, Boston Herald, Apr. 3, 2000, at 23; Annette Fuentes, }{\i A Hard Pill to Swallow:  The 10-Year Fight for Mifepristone}{, }{\scaps In These Times}{
, Mar. 21, 1999, Reproductive Rights and Wrongs, at 10; }{\i FDA Appropriations}{, }{\scaps The Pink Sheet}{, Oct. 18, 1999.}}}{
\par \tab As those
 opposed to abortion fought to keep mifepristone from American women, Mr. Lader and ARM continued in their quest to make medical abortion with mifepristone a reality for American women as soon as possible.  In July of 1996, ARM received permission from th
e FDA to conduct a study of its pill.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See New Round of Test for Abortion Pill}{, }{\scaps Chicago Trib.}{, July 31, 1996, at 6.}}}{
  The study consisted of testing on 2,000 women in Rochester, New York and clinics in the midwest and the west coast, including Oakland and San Francisco, California.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ Russell, }{\i supra}{ note 451; Larry D. Hatfield, }{\i Abortion Pill Clone to Make Bay Area Debut French RU-486 Copy Out in S.F., Oakland Next Month}{, }{\scaps S.F. Examiner}{, Aug. 20, 1996, at A7.}}}{
  In July of 1997, ARM announced that its study would be expanded, due to funding from John Merck, to at least 10,000 women.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Lewin, }{\i 
Group is Intensifying}{, }{\i supra}{ note 517.}}}{  In March of 1999, ARM reported that more than 3,000 women had taken mifepristone under the program in the prior 18 months.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright 
\fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Marc Kaufman, }{\i Abortion Pill Inches Closer to Production; American Marketer Hopeful that Drug Will Be Available by the End of the Year}{, }{\scaps Wash. Post}{, Mar. 23, 1999, at Z7.}}}{
  ARM has been testing several variations on the Population Council's regimen.  ARM's trials are studying a lower dose, 200 milligrams, of mifepristone.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn 
}{  }{\i See Mifepristone Ancillary Trial Costs Are Being Covered by Seattle Area Insurers}{, }{\scaps The Pink Sheet}{, Oct. 11, 1999; Kaufman,}{\i  supra}{ note 565.}}}{
  ARM believes that a lower dose may be equally effective in terminating pregnancy, but have a lower incidence of side effects.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Sara Silver, }{\i Activist Offers Abortion Pill In Clinical Trials}{, July 2, 1997, The Record Online <http://www.bergen.com/abortion/pill.htm>.}}}{  The ARM protocol also calls for
 only two doctor's visits rather than three; women are allowed to take misoprostol vaginally at home.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i 
See Mifepristone Ancillary Trial Costs Are Being Covered by Seattle Area Insurers}{, }{\scaps The Pink Sheet}{, Oct. 11, 1999; Kaufman,}{\i  supra}{ note 565; }{\i Mifepristone Research at the University of Rochester}{ (visited 
Apr. 10, 2000) <http://www.urmc.rochester.edu/hh/choices/ourres.html>.}}}{  Today, ARM testing continues under an IND.  ARM has not announced any plans to submit an NDA, but is primarily concerned with providing mifepristone to 
women, while the Population Council fights for approval.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  ARM also states that the study is being done to help obtain approval and to optimize the labeling of mifepristone.  }{\i See Mifepristone Research at the University of Rochester}{ (visited 
Apr. 10, 2000) <http://www.urmc.rochester.edu/hh/choices/ourres.html>.}}}{ The FMF web-site lists the 15 clinical sites where ARM's drug is available to women today.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i See}{ }{\i Reproductive Rights - Mifepristone Trials}{ (visited Apr. 10, 2000) <http://www.feminist.org/rrights/mifeptrials.html>.}}}{
\par \tab While ARM made medical abortion a real possibility for American women, Danco Laboratories continued to look for a manufacturer.  Finally, in June of 1998, Danco announced that it had found a manufacturer willing to make the drug.}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Katherine Q. Seelye, }{\i House Votes to Block F.D.A. on Approval of Abortion Pill}{, }{\scaps N.Y. Times}{, June 25, 1998, at A20.}}}{
  In March of 1999, a spokeswoman for Danco, indicated that all of FDA's outstanding issues were regarding the manufacturing of mifepristone and that the FDA still had to inspect the new manufacturing plant.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Fuentes, }{\i supra}{ note 561.}}}{  She also expressed Danco's belief that mifepristone would be available by the end of 1999.}{\cs16\super \chftn {\footnote \pard\plain 
\s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{\i   See id.}}}{  In January of 2000, the drug had still not been approved.  However, a Danco spokesman indicated that all required data was submitted to the FDA.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Laurel Campbell, }{\i Sides Ready as Abortion Pill Nears Approval by FDA}{, Scripps Howard News Service, Jan. 7, 2000.}}}{ }{\b  }{
 A spokeswoman for the Population Council expressed its hope that the FDA would approve the drug by the end of the first quarter of 2000.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Campbell, }{\i supra}{ note 574.}}}{  
\par \tab Such hopes were dashed on February 18, 2000, when t
he FDA issued another approvable letter to the Population Council indicating that remaining questions still need to be resolved before final marketing approval for mifepristone, administered in combination with misoprostol, can be granted.}{\cs16\super 
\chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Food and Drug Administration}{\scaps ,}{ }{\i FDA Issues Approvable Letter for Mifepristone}{,}{\scaps  }{
Feb. 18, 2000 (visited Mar. 27, 2000) <http:www.fda.gov/bbs/topics/Answers/Ans1005.html>.  This action was in response to the information recently submitted by the Populati
on Council regarding the outstanding issues from the approvable letter issued in September of 1996.  }{\i See}{ }{\i id.}}}{  Immediately after, Danco Laboratories said it was "preparing information to satisfy the FDA's request"}{\cs16\super \chftn 
{\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  Mifepristone}{, }{\scaps The Pink Sheet}{, Feb. 21, 2000.}}}{ and that it is confident it can answer the FDA's questions.}{\cs16\super \chftn {\footnote 
\pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Edward R. Silverman and Robert Schwaneberg, }{\i Abortion Pill Gets Conditional Approval from FDA}{, }{\scaps Knight-Ridder Trib. Bus. News}{, Feb. 19, 2000.}}}{
  Sandra Waldman, a spokeswoman for the Population Council, indicated that all outstanding issues involve the manufacturing and labeling of the drug.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{
  }{\i See}{ Marc Kaufman, }{\i FDA Again Delays Abortion Pill Approval; Questions on the Manufacturing and Labeling of RU-486 Remain Unresolved}{, }{\scaps Wash. Post}{, Feb. 19, 2000, at A2.}}}{
  The FDA declined comment, but did indicate that a final decision could come in six months.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{ Silverman and Schwaneberg, }{\i supra }{not
e 578; Food and Drug Administration, }{\i FDA Issues Approvable Letter for Mifepristone}{, }{\i supra}{
 note 576 (indicating that agency has six month goal for acting on information submitted in response to an original action under the Prescription Drug User Fee Act).}}}{
  Advocates of the pill are outraged at the continued delay and are concerned about the upcoming presidential election.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See}{ Lawrence, }{\i 
supra }{note 561; Tamar Lewin, }{\i Pending F.D.A. Approval, French Abortion Pill Is Getting Limited Use Here}{, }{\scaps N.Y. Times}{, \'a71, at 22 [hereinafter Lewin, }{\i Pending F.D.A. Approval}{].}}}{
  George W. Bush has said that if he is elected, he will try to keep mifepristone off the market.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{ }{\i  See }{Lewin, }{\i Pending F.D.A. Approval}{, }
{\i supra}{ note 581.}}}{  Sandra Waldman says, "there's still reason to be optimistic."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Silverman and Schwaneberg, }{\i supra }{note 578}{\i . }}}{
  Yet optimism is difficult to muster, after years of hearing hopeful predictions, which have never come to fruition. 
\par \tab As of March 2000, the FDA has still not granted final marketing approval for the use of mifepristone, in combination with misoprostol, for medical abortion.
\par }\pard \qc\sl480\slmult0\widctlpar\adjustright {
\par Part V
\par }\pard \qj\sl480\slmult0\widctlpar\adjustright {\tab For over a decade, anti-abortion groups have worked to keep mif
epristone out of the United States while pro-choice groups, as well as medical researchers, have strategized to counteract such pressure.  Anti-abortionists have threatened to boycott the product lines of any company involved with the distribution or manu
f
acture of mifepristone, as well as boycott investments in any such company.  Less explicitly, anti-abortion groups have instilled a fear of violence in potential manufacturers, since anti-abortion groups have shown time after time that they are not above 
u
sing violence.  On the other side, pro-choice groups have attempted meeting with the patent owner and potential manufacturers to rationally discuss the issues; such groups have also attempted to persuade such companies with petitions by showing them the m
a
jority is behind mifepristone.  Medical researchers have participated in congressional hearings to discuss the issues and urge governmental action.  Only those who have circumvented traditional FDA approval to provide the drug to women, such as Lawrence L
a
der, have had any real success.  Not surprisingly, so far the anti-abortionists are winning the battle; they have successfully delayed the introduction of mifepristone for over a decade and although its approval now appears imminent, "it's still a guess .
.. on when the drug will be available."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  Campbell, }{\i supra}{ note 574.}}}{
\par \tab From the start, the abortion controversy has tainted the life of the abortion pill in the United States.  Anti-abortion members of Congress prompted the FDA to issue an import alert for mifepristone. In turn, Rousse
l-Uclaf, which was already shown to be sensitive to public opinion, perceived the FDA's singling out of mifepristone as a reflection of the government's disapproval of the drug.  The perceived disapproval by the government, coupled with anti-abortion thre
a
ts, caused Roussel-Uclaf to stop supplying the drug for medical research, let alone consider applying for approval in the United States.  Pro-choice groups and medical researchers were unable to persuade Roussel-Uclaf to change it staunch position.  Only 
w
hen President Clinton, responding to his pro-choice electorate, requested that the Department of Health and Human Services review the import alert of mifepristone and promptly assess initiatives by which the department could promote the testing, licensing
,
 and manufacturing of mifepristone in the United States, was Roussel-Uclaf willing to talk.  Even with the Chief Officer of the United States behind it, Roussel-Uclaf hesitated.  The company still felt the pressure of anti-abortion groups, more specifical
ly the Vatican had begun heavily pressuring Roussel-Uclaf and Hoechst to stop the distribution of mifepristone.  Not until a year after negotiations began was an agreement reached between Roussel-Uclaf and the Population Council.  
\par \tab Although it was said tha
t there would be no barriers once Roussel-Uclaf decided to bring mifepristone to the United States, the problems did not stop there.  After a successful United States' clinical trial, the FDA issued an approvable letter.  Proponents of mifepristone believ
e
d approval was imminent.  However, the project hit a snag.  American manufacturers were not immune to the controversy surrounding the drug.  They too feared boycotts and violence.  In return for working with the drug, companies wanted confidentiality.  Th
e
 FDA and the Population Council, in an unusual move, agreed to provide the desired secrecy.  After major pharmaceutical firms refused to touch the project, the Population Council agreed to an unusual business proposal.  The proposal was unique and quite c
o
mplex, and the need for confidentiality prevented the Population Council from scrutinizing the project and the leader's actions.  Moreover, the Council's decisions evidenced a lack of good business judgment.  As a consequence, the Council became entrenche
d
 in legal and business disputes.  The project lost valuable time and money.  Having also lost a manufacturer, the Council and its distributor, Danco, had to begin looking anew; anti-abortion threats were still in the air and the recent legal disputes furt
her tainted the project.
\par \tab After a difficult search, Danco found a new manufacturer, and the Population Council was finally able to submit a response to the September 1996 approvable letter.  However, not all outstanding issues have been adequately addressed
, according to the FDA.  The FDA issued another approvable letter, on February 18, 2000, indicating there are remaining questions to be resolved.  Assuming Danco and the Population Council can file a timely response to such issues, a final decision regard
i
ng the drug should be made by the end of 2000.  However, a glance at history suggests that this may not be a valid assumption.  If history is any indication, there is no telling what could go wrong.  But still there is a real possibility that American wom
en will have access to mifepristone in the year 2000.
\par \tab After a ten year long delay, it is hard to say that pro-choice groups have won the battle.  The battle may not even be over.  Anti-abortionists will continue to make themselves heard.  For example, in r
esponse to the FDA's issuance of the second approvable letter, anti-abortion groups repeated their threat to boycott any manufacturer.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super \chftn }{  }{\i See}{
 Silverman and Schwaneberg, }{\i supra }{note 578}{\i . }}}{  Abortion opponents have also indicated that they will picket places where the drug is available.}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {\cs16\super 
\chftn }{  }{\i See}{ Stacey Schultz, }{\i Long-awaited Abortion Pill Will Offer More Privacy - but No Less Controversy}{, }{\scaps U.S. News & World Rep.}{, Feb. 28, 2000, at 79.}}}{  And the victory may 
not have the impact many hoped.  Mifepristone has been hailed as a drug that will change the abortion landscape, providing greater, as well as safe, access to abortion for women.  Such success remains to be seen; FDA approval alone will do little to help 
women, if the drug is not adequately supplied by manufacturers and provided by doctors.  In any event, "American women will wait a while longer for the abortion pill."}{\cs16\super \chftn {\footnote \pard\plain \s18\widctlpar\adjustright \fs20\cgrid {
\cs16\super \chftn }{  }{\i FDA Approval of Sale of Abortion Pill in U.S. to Be Delayed Longer}{, }{\scaps Wall Street J.}{, Feb. 22, 2000, at B39.}}}{                   
\par 
\par }}