Ideals and Issues From a Critical View of the Supreme Court’s Jurisprudence
in FDA Regulation of Human Drugs
					
By

Daniel Park Chung

Abstract: Since Congress first enacted an extensive regulatory regime for human drugs in 1906 with the Pure Food and Drug Act, the Supreme Court has shaped the contours of federal drug regulation with a variety of legal doctrines and policy prescriptions, particularly with regard to the regulatory authority of the federal Food and Drug Administration (FDA).  At the same time, the Court has constructed and reinforced key ideals of drug regulation that both inform the authority of the FDA and foreclose or mitigate other ideals that are crucial to understanding the public interest in drug regulation.  This essay provides a broad overview of the Court’s jurisprudence in the area of federal drug regulation, first by briefly summarizing the statutory history and the Court’s decisions.  The essay then gleans three major ideals from these decisions: prophylactic public health purposes, agency self-legitimation, and democratic process.  Finally, the essay criticizes the Court’s jurisprudential moves, particularly that of underestimating the democratic process ideal.  In addition, it provides preliminary conclusions on how the Court and the government overall, through a promotion of greater public participation in the regulatory process, stronger recognition of “public rights,” and a more cooperative vision of government-industry relations, can better effect elements of democratic process in an area of regulation that is intimately connected to everyday life. 

I. Introduction									 Page   1
II. A Brief History of the FDA Regulation of Drugs					3
III. The Court and FDA Regulation of Drugs
A.	A Question of Opinion							9	
B.	FDA Enforcement Authority						12
C.	Readings of the FDCA							19
D.	Judicial Review and Deference						23
E.	FDA Jurisdiction								28
IV. Legal Ideals in the Court’s Jurisprudence
A.	The Prophylactic Public Health Ideal					33
B.	The Agency Self-Legitimation Ideal					38
C.	The Democratic Process Ideal						45
V. Preliminary Conclusions
A.	More Consideration of Democratic Process: Public Participation 	50
B.	Yet More Consideration of Democratic Process: Public Rights		60
C.	Attitude Toward the Industry						63
VI. Conclusion									67

I. Introduction
Both the Food and Drug Administration (FDA) and the United States Supreme Court play crucial roles in the federal government and everyday life.  The FDA regulates items that are integral to our lives and to a great extent taken for granted in terms of their availability, safety, and effectiveness.  The Court, for better or for worse, defines public values through the lens of legal disputes.  As to each other, the Court serves different roles—at times, it serves as check on the FDA, and at others the Court exhorts the FDA’s decisions and thereby legitimates them.  The Court also sets legal and policy parameters for the FDA.  What are incredibly important yet often ignored about these parameters are deep-seated but often flawed and ossifying assumptions about everyday life as the public experiences it.  These assumptions form the basis of how our government, and in particular how our courts, shape the FDA’s authority.  In turn, these assumptions shape the politics of regulation, and inevitably the law of regulation as well.
The key to uncovering and evaluating these assumptions starts with a different, critical perspective through which we can identify what counter-theories and counter-images are foreclosed or swept under the rug by the Supreme Court’s dominant theories and dominant images.  Such a critical perspective is a condition to developing a model for comprehending the deep structure of a particular area of regulation, both in terms of its internal doctrinal coherence and in terms of its politico-social import.  It calls for a model that accounts for the contributions of public trust and democratic pluralism as functioning determinants in the FDA’s regulatory decisions and the Court’s judicial review, and as a set of political symbols crucial to fashioning and shaping the character of contemporary American life.  Without such a model we will not be able to understand either the developmental path of FDA regulation as law or its function in reinforcing and legitimating the triangle of relationships among government, industry, and public.
 	Primarily for purposes of manageability, I will limit my discussion to the FDA’s regulation of human drug products and the Supreme Court’s decisions governing this area of the FDA’s authority.  One would be hard pressed to question the critical importance of these products to our lives.  Matters of life and death often hinge on the availability, safety, or effectiveness of a particular drug.  Indeed, it is this indispensability to everyday life that I emphasize throughout the essay as the background to the possibility and necessity of reconceiving the Court’s vision of FDA regulation.  In addition, I have included five cases that involve regulation of food products because they cover, or arguably so, drug products as well.  Moreover, they are seminal cases in crucial areas of the FDA’s overall authority.  
In broad outline, my purposes in this essay are: (1) to summarize the Supreme Court’s decisions on drug regulation issues, starting with cases arising from the 1906 Pure Food and Drug Act; (2) to identify and elaborate broad principles, policies, and purposes from this body of Supreme Court cases, what I will collectively call the Court’s “ideals” in this area of jurisprudence; and (3) to share some of the preliminary conclusions of the critical approach to this area of the Supreme Court’s jurisprudence (and the regulatory world as a whole), as well as to point out some of the complexities of approaching the Supreme Court’s jurisprudence on drug regulation from a critical perspective.  
Just to reiterate, the political issues that are so close to the surface of the Supreme Court’s jurisprudence in this area provide for a broad range of transformative possibilities.  Critical examination of these issues may clue judges and policymakers into less constrained short-run solutions to problems of drug regulation, as well as more helpful and equitable re-framings of the players in drug regulation: the FDA, state and local authorities, the courts, elected officials, the industry, the professions involved in drug regulation, and the consuming public.  In this essay, I hope to provide a starting point for this possible reorientation of the legal ideals and rules of drug regulation. 
 
II. A Brief History of the FDA Regulation of Drugs
Before recounting the Supreme Court’s activity in the area of FDA drug regulation, a summary of federal drug legislation may be useful in providing the historical and statutory background to the Court’s jurisprudence.  Though this essay is not historiographical, it would be difficult to argue that much of the development of the law, as enacted and shaped by both Congress and the Court, has not depended on historical contingencies.  Moreover, these historical contingencies further highlight the need to conceive the law of drug regulation beyond the Court’s doctrines and legitimating ideals.
The Pure Food and Drug Act of 1906 (“PFDA”) marked the first significant federal law regulating medicinal drugs. The increasing use of chemicals and uncertain practices in food processing, as well as the subsequent publication of Upton Sinclair's, The Jungle, sparked the initial public outrage that led to its passage.
To address the sanitation crisis, the PFDA delegated power to the Bureau of Chemistry in the Department of Agriculture, which was the predecessor of today’s FDA.  The Bureau of Chemistry had authority to intervene against the sale of misbranded or adulterated drugs in interstate commerce.  The PFDA did not, however, grant the Bureau of Chemistry authority to require pre-market evidence of drug safety or effectiveness.  The Bureau could only prevent the marketing of an ineffective drug if it could demonstrate that the seller had actual knowledge that its claims were false and that the drug actually failed to work. 
Congress amended the PFDA six times between 1906 and its repeal in 1938, but these amendments proved insufficient to redress the Act’s limited delegation of power to the Bureau.  To a large degree, the PFDA focused on preventing economic fraud rather than protecting the public from deleterious drugs.  It took a public health disaster for Congress to create an agency with broad authority to regulate drugs. In what would be called the “Elixir Sulfanilamide” fiasco, a manufacturer marketed a liquid drug that killed at least seventy-three people in the two months that it was on the market in 1937.  The drug manufacturer used diethylene glycol, commonly used in antifreeze, as the solvent in the new drug. It had never tested diethylene glycol to determine whether human beings could use it safely.  In response to this disaster, the Secretary of Agriculture asked Congress for legislation that would require testing of new drugs. 
Shortly thereafter, Congress approved the Federal Food, Drug, and Cosmetic Act of 1938.  The FDCA authorized the Food and Drug Administration to require pre-market notification of new drugs for their safety.  Indeed, under the FDCA a manufacturer of a “new drug” must conduct tests demonstrating that the drug is safe for the use specified on its label.  The FDCA does not specify criteria for assessing safety; Congress left such assessments to the judgment of the FDA.  Subsequently, the manufacturer must notify the FDA before it can provide the drug for sale or consumption. However, manufacturers had the right to determine whether their products were new drugs. If a manufacturer determined that its product was not a new drug, but, instead, “generally recognized as safe and effective,” it did not have to submit data to the FDA.  In such instances, a drug could be marketed without any FDA review.  
In September of 1960, a drug company notified the FDA that it intended to market thalidomide as a new drug. According to one account of what ensued, Dr. Frances Kelsey, the examiner reviewing the submission, refused to permit marketing of the drug because its manufacturer had failed to provide sufficient evidence of the product’s safety.  The decision to keep thalidomide off the shelves of American drug stores turned out to be a critical decision. In the interim, phocomelia, a condition wherein infants are born without hands or feet, arose at high rates in Western Europe. In 1961, thalidomide was identified as the cause for the outbreak. The company sponsoring the drug withdrew its notification in March of 1962. 
Following the thalidomide tragedy in Europe and the FDA’s role in preventing a corresponding disaster in the United States, Congress was inspired to give the FDA greater authority over the regulation of new drugs.  In the 1962 Kefauver-Harris Amendments (“1962 Amendments”), Congress explicitly granted the FDA the authority to review and approve drugs for their effectiveness as well as their safety.  These amendments made effectiveness a separate criterion for approval, and they specified the kind of information manufacturers were required to submit to demonstrate effectiveness: data from “adequate and well-controlled studies.”  
Under the 1962 Amendments, the FDA engaged in an assessment of relative risk, balancing benefit with risk. Though the FDA still assesses relative risk when determining whether to approve a new drug, under the 1962 Amendments, the FDA cannot approve an ineffective drug even if it poses no health risks. The new effectiveness standard marked an important advance from policies mandated by the PFDA of 1906 and the FDCA as originally enacted in 1938. 
The 1962 Amendments also transformed the pre-market notification system created by the FDCA into a pre-market approval system. The notification system permitted a manufacturer to sell its drug 60 days after submitting the product’s new drug application if the FDA failed to raise an objection. In contrast, the approval system prohibited a manufacturer from selling its drug until the FDA had affirmed the product’s safety and effectiveness.  As a result, Congress shifted the burden of proof from the FDA to the manufacturer. Congress also delegated to the FDA the authority to withdraw the approval of a new drug if the FDA determined, based on new information, that the drug was no longer safe or effective for its purported use. 
In 1962, therefore, Congress changed the FDA from an agency with limited powers to one that was to exercise a great deal of discretion over which drugs would be allowed on the American market. Congress had given the FDA an enormous mandate: the FDA would have the final decision as to which drugs were safe and effective enough to reach the market.  Moreover, Congress has signaled its approval of many of the FDA’s activities by passing legislation to codify those procedures, most notably the Food and Drug Administration Modernization Act (“FDAMA”), which adopted the FDA’s accelerated approval regulations.  Thus, Congress has stepped aside to allow the FDA to respond first to changing circumstances in drug regulation and public health. Congress retains the ability, however, to step into the debate whenever it wishes and override an agency action.

III. The Court and FDA Regulation of Drugs
	The Supreme Court’s decisions involving the FDA and drug regulation involve a variety of administrative law issues.  Much of the Court’s opinions, particularly those dealing with the FDCA and its subsequent amendments and additions, trace the legislative history of the FDA’s statutory authority as a mode of argument.  In this section, I will briefly recount these opinions chronologically by theme.  
A. A Question of Opinion
	Before Congress enacted the PFDA in 1906, the Supreme Court decided in favor of the American School of Magnetic Healing, which had engaged in the business of healing human diseases through appeals to the mind, in the context a federal mail fraud statute.  A large part of the School’s business consisted of providing “treatment” by letters to people throughout the world.  The School sought an injunction, enjoining the defendant local postmaster from continuing to comply with an order issued by the Postmaster General directing the defendant to return all letters addressed to the School to the original senders with the word “fraudulent” stamped on the outside, and to refuse payment of any postal order drawn to the order of the School.  In issuing the order, the Postmaster General relied on a federal statute granting him discretion to instruct local postmasters to take such preventive steps against any person found to be engaged in a “…scheme or device for obtaining money through the mail by means or false or fraudulent pretenses, representations, or promises….”  The Supreme Court, in reversing the lower court’s dismissal of the School’s application for injunctive relief, questioned the government’s authority to regulate the truth of therapeutic claims.  The Court asserted that the value of these claims “is a question of opinion” and that, according to the record, there were “many believers in the truth of the claims set forth” by the School, and “it is not possible to determine as a fact that those claims are so far unfounded as to justify a determination that those who maintain them and practice upon that basis obtain their money by false pretenses within the meaning of the statutes.”
Nine years later and five years after the passage of the PFDA, the Court in United States v. Johnson, which involved misleading therapeutic claims for a cancer cure, interpreted the FDA’s authority in a strikingly narrow way to avoid a constitutional issue.  Writing the majority opinion, Justice Holmes interpreted a statutory provision prohibiting false or misleading statements about a drug or its ingredients as covering only deception about the identity of the drug or its ingredients, but not about its therapeutic benefits.  The Court doubted Congress would “distort the uses of its constitutional power [by] establishing criteria in regions where opinions are far apart.”  Clearly, the Court was influenced by the rationale of McAnnulty.  While Justice Holmes is seen as the champion of an expansive view of Congress’s authority with respect to economic regulation, in this case, he saw the issue as involving regulation of opinion, even though the opinion was that of a commercial manufacturer.  Congress responded the next year by prohibiting false and fraudulent claims as to therapeutic value as well as the identity and composition of drugs and their ingredients.  The Court in Seven Cases v. United States then upheld the law against a due process challenge because standards could be found in the prohibition of known falsehoods and because the manufacturer had superior knowledge as to the claims.  The Court argued that the motivation behind the 1912 amendment was Congress’s recognition of  “a wide field in which assertions as to curative effect are in no sense honest expressions of opinion, but constitute absolute falsehoods,” and are hence “fraudulent.”  The plaintiff Eckman Manufacturing Company had sold drugs, claiming that they “had cured” and “will cure” tuberculosis, when in fact, according to the government’s libel, no “medicinal substance nor mixture of substances known at present” effected a cure for the disease.  
The Court revisited its “matter of opinion” notion in 1922 with Leach v. Carlisle, which again involved the Postmaster General deciding that a drug company’s product did not produce the health results claimed for it.  The Court held that the Postmaster’s conclusion was entitled to deference when Congress had committed such decisions to him by law and where the conclusion “is fairly arrived at and has substantial evidence to support it….”  More than twenty-seven years later, in Reilly v. Pinkus, the Court again declined to extend McAnnulty, this time to reverse a decision by the Postmaster General to forbid delivery of mail containing fraudulent claims regarding a diet supplement.  The producer and distributor of the supplement argued that McAnnulty barred a finding of fraud whenever “there is at least a conflict of opinion as to curative effects of a remedy.”  The Court, though rejecting this argument, accepted McAnnulty as a “wholesome limitation upon findings of fraud…when the charges concern medical practices in fields where knowledge has not yet been crystallized in the crucible of experience.”  Overall, the Court evinced what can be considered a timeless ambivalence between limitation and progress, or between the need to give effect to Congressionally delegated authority and the primacy of industry over experimentation and innovation in the “science of medicine.”
B. FDA Enforcement Authority
In the area of FDA enforcement jurisdiction and enforcement mechanisms, the Court historically has done a great deal to knock down traditional barriers of criminal law and equitable remedies to give the FDA and its enforcement partners considerable latitude in carrying out the mandates of the FDCA’s drug regulation provisions.  At the outset of the FDCA, the area of criminal liability was especially controversial.  The FDA names individual corporate officers or employees in all of its criminal cases.  The FDCA imposes strict vicarious misdemeanor liability on responsible corporate officials.  The fact that a corporate officer had no direct involvement in the conditions giving rise to a criminal violation does not protect that officer from prosecution or liability.  
Before any case involving the FDCA, however, the Court in 1911 decided similar issues with the PFDA in United States v. Morgan.  The defendant small-time drug manufacturers, moved in arrest of judgment on the ground that under Section 4 of the PFDA, they had not been given notice and a preliminary hearing by the Department of Agriculture and that such procedure was a condition precedent to the return of a valid indictment.  The Court thought differently, asserting that the Department of Agriculture’s administrative and scientific proceedings should not impede the district attorneys’ prosecutorial duties and capabilities.  The Court suggested that grand juries were well-equipped to handle what the defendants argued were required to be managed by the federal Department of Agriculture.  Morgan was an instance in which the Court liberalized enforcement of drug regulation by refusing to carve out an exception to what it deemed traditional “criminal law.”  
As for the FDCA, the seminal case in this area of FDA enforcement is United States v. Dotterweich, decided by the Court in 1943.  Dotterweich involved the prosecution of the president of a company with twenty-six employees in one facility.  Dotterweich was found guilty of distributing misbranded and adulterated drugs in interstate commerce.  He argued that his lack of involvement with the distribution should bar his criminal conviction.  The Court disagreed vigorously, holding that “[u]nder §301 a corporation may commit an offense and all persons who and abet its commission are equally guilty” and that “[b]alancing relative hardships, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless.” 
Four years later in United States v. Walsh, the Court revisited Section 301 of the FDCA in holding that the Act prohibited “the giving of a false guaranty to one engaged wholly or partly in an interstate business,” regardless of whether that particular guaranty led to an illegal shipment in interstate commerce.  The Court made two key assumptions.  First, it posited that a manufacturer generally has “no way of knowing whether a dealer, whose business includes interstate sales, will redistribute a particular shipment in interstate or intrastate commerce.”  Second, the Court claimed that if the manufacturer guarantees to the dealer that his product is not misbranded or adulterated within the meaning of the FDCA, the dealer likely will distribute the product in interstate commerce without independently checking for FDCA compliance.  The defendant California-based drug manufacturer argued that Section 301(h) applied only to a guaranty that was false relative to an interstate shipment; the shipment at issue was made to a California-based consignee and no evidence had been presented that this consignee had purchased the order for a customer outside California or that it intended to sell the products in interstate commerce.  The Court felt no need to require that the product be put into interstate commerce; instead, it held that “the possibility that a false guaranty may give rise to an illegal interstate shipment by such a dealer is strong enough to make reasonable the prohibition of all false guaranties to him,” even if a particular shipment may eventually travel only in intrastate commerce.  In the Court’s interpretation of the FDCA, Congress had sought to enhance the Act’s effectiveness against “evils” by “cut[ting] [them] down at their source.”
In 1950, the Court used a similar appeal to Congressional intent in upholding the FDA’s multiple seizure enforcement measure under Section 304(a) of the FDCA.  Because of the great impact of multiple seizures on distribution and sales of a target product, industry players leveled a number of constitutional challenges to the statutory scheme, eventually leading to Ewing v. Mytinger & Castleberry, Inc.  The FDA alleged that the defendant had misbranded its dietary supplement products with misleading health claims, and accordingly pursued seizures in eleven jurisdictions throughout the country.  The Court, per Justice Douglas, held that the opportunity afforded a claimant to appear and have a full judicial hearing after the seizures satisfy the Due Process Clause of the Fifth Amendment.  As long as “there is at some stage an opportunity for a hearing and a judicial determination,” an individual’s property rights are constitutionally protected.  The Court stressed that Congress had not given courts judicial review of the FDA’s finding of probable cause (to institute multiple seizure proceedings); Congress had been “highly selective” in its provision of judicial review in the FDCA.  Similar to the language Justice Frankfurter had used in Dotterweich, the Court explained that Congress had properly weighed the devastating impact of the multiple seizure procedure on industry against the potential injury to the public from misbranded or adulterated products.
Only two years later, the Court took the industry’s side with regard to the FDA’s use of another special remedy, factory inspections, despite its acknowledgement of the crucial place such remedies had in the FDA’s enforcement scheme.  In United States v. Cardiff, the Court limited the FDA’s use of such inspections.  The defendant, the president of an apple processing company, refused permission to FDA agents to inspect his factory at reasonable hours.  Under Section 301(f) of the FDCA, he was convicted and fined.  The Court, reversing the conviction, held that Section 301(f) prohibits the refusal to permit inspection only if permission to inspect had been previously granted.  Criminal liability based on the failure to give permission or the revocation of previous permission was void for vagueness.  Justice Douglas posed a number of uncertainties from such a construction of the section: “Would revocation of permission once given carry the criminal penalty no matter how long ago it was granted and no matter if it had no relation to the inspection demanded?  Or must the permission granted and revoked relate to the demand for inspection on which the prosecution is based?”  The government’s narrow construction of Section 301(f) also suffered from lack of opportunity and notice; the Court read the section to give the defendant the right to withhold permission.
In United States v. Wiesenfeld Warehouse Company, the Court dealt with the question of whether a defendant public storage warehouseman could be held criminally liable for holding food under unsanitary conditions whereby the food might have been contaminated by filth.  The defendant presented an impossibility defense, claiming that he “‘is, by the very nature of his business powerless’ to protect against this kind of contamination, however high the standard of care exercised.”  Dismissing this defense as a factual matter to be determined at trial, the Court emphasized a background principle to FDA enforcement, that “guilty intent is not always a prerequisite to the imposition of criminal sanctions.”  Overall, the FDCA covered not only those holding title to offending goods, but also those transporting and storing them.
Continuing the pro-enforcement stance of Dotterweich and Wiesenfeld Warehouse Company, the Court in United States v. Park imposed a “positive duty to seek out and remedy violations” as well as “a duty to implement measures that will insure that violations will not occur” on corporate actors entrusted with “supervisory responsibility.”  The case involved a corporate officer who had been charged with adulteration of food products.   The Court held that the District Court’s instructions to the jury adequately focused on the issue of the defendant’s authority over the conditions that formed the basis of the FDCA violations.  The judge had advised the jury that to find guilt it had to find that the defendant “had a responsible relation the situation,” that the “situation” was the warehouse’s condition, and that the defendant had “authority and responsibility” to deal with the “situation” by virtue of his position as president of the company.
Seventeen years later, the Court upheld the seizure of a single dosage of the French abortion pill RU-486 from a pregnant woman who had tried to get it past airport customs.  The Court limited its one-page opinion to a holding that the woman had failed to demonstrate a substantial likelihood of success on the merits of her claim that she was entitled to return of the pill because an administrative document to seize the pill was promulgated without notice-and-comment procedures allegedly required under both the Administrative Procedure Act and FDA regulations.  The Court deferred to the FDA’s interpretation of the relevant provisions on notice-and-comment proceedings.  It also declined to express a view on the claim that the seizure amounted to an undue burden on the woman’s constitutionally protected abortion rights.  In his dissent, Justice Stevens took up this due process argument, contending that the record did not support the government’s sole interest in avoiding any “significant health risk” associated with RU-486 when prescribed by a physician.
In another case involving the Fifth Amendment, the Court in United States v. Kordel held that the vice-president of a drug corporation, who answered the FDA’s interrogatories in a civil proceeding to condemn shipments of the corporation’s allegedly misbranded products, could have invoked his Fifth Amendment privilege against compulsory self-incrimination.  Having failed to do so, he could not claim that he was compelled to testify against himself as a ground for overturning his criminal conviction, even if his answers to the FDA’s interrogatories provided evidence or leads useful to the government in his criminal prosecution.  The Court deferred to the FDA’s regular practice of preparing interrogatories upon receipt of a claimant’s answer to a civil libel; such practice did not constitute “bad faith” on the part of the government and was necessary to the FDA’s effort at streamlining litigation through securing admissions and building cases for summary judgments.  Quick agency action was essential to “the public interest in protecting consumers throughout the Nation from misbranded drugs.”  Requiring the FDA to choose between quitting a criminal prosecution once it seeks civil relief and deferring civil proceedings pending the outcome of a criminal prosecution would “stultify” this interest.
C. Readings of the FDCA
The Court has read the FDCA to reach activities that were conducted almost completely intrastate.  In United States v. Sullivan, for example, the broad parameters of the language “held for sale after shipment in interstate commerce” in Section 301(k) were held to include a resale of misbranded sulfathiazole six months after the defendant had received the goods in question in interstate commerce.  Doing away with any arguments of how long a particular article had been in the hands of a middleman or distributor, the Court construed Section 301(k) “to the full extent constitutionally possible” and expanded its coverage to “every article that had gone through interstate commerce until it finally reached the ultimate consumer.”
Along the same pro-regulation vein, the Court read the FDCA’s misbranding provisions expansively in Kordel v. United States.  The defendant, a producer of health foods and drugs, distributed two sets of products, the first containing the drugs and the explanatory literature in the same carton. As for the second set, the literature was shipped separately from the drugs. The question before the Court was whether the separate shipment of the literature saved the drugs from being misbranded within the meaning of the FDCA.   The Court refused to read the misbranding provisions restrictively and concluded that the false and misleading literature in the second set, because it was designed for use in the distribution and sale of the accompanying drug, were not exempt from the FDCA.
In a similarly broad reading of the FDCA, the Court in United States v. An Article of…Bacto-Unidisk held that a laboratory aid used to help determine the proper antibiotic drug to administer to patients was a “drug” within the FDCA’s definition and was hence subject to pre-market clearance regulations promulgated by the FDA under the Section 507 of the Act.  In doing so, the Court claimed to construe the word “drug” more broadly than the medical profession did, in accordance with the “structure, the legislative history, and remedial nature of the Act.”  Perhaps more important were the pre-market clearance regulations, which existed for “drugs” but not for “devices,” the latter being what the defendant manufacturer wanted his product to fall under.  In effect, the Court deferred to the FDA’s classification of the laboratory device in conjunction with the FDA’s determination that the aids posed a serious public health risk.  Deference on the latter issue was complete.
In four cases argued on the same day in 1973, the Court handled a series of issues arising from the 1962 Amendments.  In Weinberger v. Hynson, Westcott & Dunning, Inc., the Court upheld the FDA’s right to deny an evidentiary hearing in a proceeding to withdraw approval of a “new drug application” when the applicant failed to make the threshold showing of effectiveness required by the FDA in a regulation issued under the FDA’s rulemaking authority, according to Section 701(a) of the FDCA.  The Court also upheld the FDA’s use of summary judgment proceedings in applying the effectiveness requirements of the 1962 Amendments to previously approved prescription drugs.  The Court noted the magnitude of the FDA’s task, in light of the thousands of pre-1962 drugs still on the market, and the difficulty, if not impossibility, of accomplishing the statutory objective “[i]f FDA were required automatically to hold a hearing for each product whose efficacy was questioned.”   
In CIBA Corp. v. Weinberger, the Court held that the FDA has jurisdiction in an administrative proceeding to determine whether a drug product is a “new drug” within the FDCA’s definition of the term, subject to review by a federal Court of Appeals; a claimant may not relitigate the issue in another proceeding.  Deference to the FDA was clear: “A decision that FDA lacks authority to determine in its own proceedings the coverage of the Act it administers, subject of course to judicial review, would seriously impair FDA’s ability to discharge the responsibilities placed on it by Congress.”  The Court went further in suggesting that in cases where the “new drug” issue was presented to a district court before the FDA had formally instituted administrative proceedings on the issue, the district court might abstain, pending the FDA’s determination on the issue, before continuing with others. 
In Weinberger v. Bentex Pharmaceuticals, Inc., the Court held that the FDA has jurisdiction to decide, with administrative finality, the “new drug” status of individual drugs or classes of drugs; it added that the referral of “new drugs” issues to the FDA is appropriate.  The Court gave a classic pro-expertise argument, concluding that the inquiry of whether a drug is a “new drug” depends heavily on “expert knowledge and experience of scientists based on controlled clinical experimentations and backed by substantial support in scientific literature.”  The Court also suggested that its decision was in harmony with its validation of the FDA’s authority to withdraw NDA’s in Hynson—the “reach of scientific inquiry” in both issues “is precisely the same.”  Absent this allotment of jurisdiction, the Court foresaw “a deluge of litigation if…drugs had to receive de novo hearings in the courts….”  The fear was that such a result would play into the hands of manufacturers and distributors.   
In USV Pharmaceutical Corp. v. Weinberger, the Court upheld the FDA’s rulemaking, again pursuant to Section 701(a), that withdrew approvals for  “new drug applications” (NDAs) containing citrus bioflavonoid because they had not been subjected to the new effectiveness requirements of the 1962 Amendments.  The Court, interpreting the “grandfather” clause of the 1962 Amendments, concluded that the phrase “any drug” is used in the clause in the “generic sense,” which meant that “me-too” drugs, or copies of those drugs with effective NDA’s, whether the products of the same or different manufacturers covered by an effective NDA, were not exempt from the effectiveness requirements.  After going through an elaborate etymological argument on the terms at issue, the Court emphasized Congress’ intent to give the FDA a speedier, internal measure by which to test the effectiveness of new drugs; otherwise, the FDA would have to pursue such drugs through the FDCA’s misbranding provisions, which would call for the slower, more cumbersome procedure of the government having “to sustain its burden of proving the violation in court.”
The Court detailed its basic position regarding generic drug products in USV with its decision in U.S. v. Generix Drug Corp.  It held that a generic product is a “drug” for purposes of the FDCA and hence is subject to prior FDA approval until the entire product, and not just its active ingredients, no longer count as “new.”  Particularly convincing to the Court was the FDA’s scientific evidence that differences in inactive ingredients in generic products often affected their safety and effectiveness, especially with regard to the rate at which the active ingredient is delivered to a diseased organ.
D. Judicial review and deference  
Overall, the Court has deferred a great deal to the FDA on a number of issues, from interpretations of the statutes themselves to individual enforcement decisions.  In an early case arising from the PFDA, the Court upheld a regulation promulgated by the Secretaries of the Treasury, Agriculture, Commerce, and Labor as a proper exercise of power under Section 3 of the PFDA and accordingly not invalid as an attempt to add to Section 8, which laid out the definition of “misbranded.” In the regulation, the Secretaries required the label on a drug containing the derivative of any of the drugs enumerated in the PFDA to show not only the presence of the derivative, but to state the name of the drug from which it was derived as well.  In deferring to this administrative rulemaking, the Court referred to the fact that Congress had given such authority to three governmental departments as evidence of the complexity of PFDA-covered regulation.  Moreover, the regulation was consistent with what the Court posited to be the purpose of PFDA, “to prevent the surreptitious sale of certain noxious drugs or their derivatives, the latter supposedly partaking of the quality of parent article and as effective of evil consequences.”  
In a similar showing of deference to the Secretary of Health, Education, and Welfare, the Court in Flemming v. Florida Citrus Exchange held that the Secretary properly removed the “harmless” certification of a particular red coal tar color used to color oranges commercially grown in Florida and Texas.  The Secretary had based his decision on evidence indicating that the artificial coloring had a poisonous effect on animals in quantities as small as 0.1 percent of their diet; he had not determined that the substance was harmful for human consumption.  The Court, employing arguments of Congressional intent and statutory purpose, explained that “[i]n light of the overall purpose of the Act,…, and the specific terms here involved, it seems to us that Congress did not intend that a verdict of ‘not proven’ on the questions mentioned should not preclude the Government from preventing the use of substances like the one in question when they were shown to have poisonous effects by themselves.”  The Court endorsed the Secretary’s strict reading of “harmless,” concluding that Congress intended to give the Secretary discretion to determine whether certain substances were “harmless” in a narrow or more relative sense.   
	The most widely discussed case concerning judicial review of FDA, and all agency action for that matter, is Abbott Laboratories v. Gardner.  The case dealt with the issue of whether a set of drug labeling regulations promulgated pursuant to Section 701(a) of the FDCA were ripe for pre-enforcement judicial review.  A group of drug manufacturers and the Pharmaceutical Manufacturers Association challenged the regulations on the ground that the FDA Commissioner exceeded his authority under Section 701(a).  In addressing the issue of ripeness for judicial review, the Court held that it would not imply a preclusion of judicial review unless there is clear and convincing evidence of Congressional intent.  The Court distinguished Ewing v. Mytinger & Castleberry, Inc. on a number of grounds, essentially boiling down to the notion that the FDA’s finding of probable cause to institute proceedings is largely preliminary and not as potentially intrusive as an industry-wide regulation; equating the two would “immunize nearly all agency rulemaking activities from the coverage of the Administrative Procedure Act.”
In United States v. Rutherford, the Court deferred to an FDA determination that Laetrile, a cancer treatment drug, constituted a “new drug” under the 1962 Amendments and was thus subject to safety and effectiveness standards.  The FDA rejected plaintiffs’ contention that the standards did not apply to drugs used by the terminally ill.  The Court considered the language of the Act “plain and unambiguous” on the issue and that making an exception for Laetrile was not “necessary to attain congressional objectives or to avert an unreasonable reading of the terms ‘safe’ and ‘effective.’”  Justice Marshall referred to the fact that the FDA had never made exception for drugs used by the terminally ill.  For such “issues of considerable public controversy” and absent contrary Congressional action, the Court asserted a rule of judicial deference to the FDA’s application of the Act.
Six years later, in Heckler v. Chaney, the Court decided the seminal case on the availability of judicial review of agency inaction.  Death row inmates sued to require the FDA to take enforcement action under the FDCA’s misbranding provision to prevent particular drugs from being used in executions by lethal injection.  The Court upheld the FDA’s inaction as an unreviewable exercise of prosecutorial discretion.  Justice Rehnquist explained that there was “no law to apply” to evaluate the Commissioner’s inaction;  hence, it fell under the “committed to agency discretion” exception to the general rule of reviewability under the Administrative Procedure Act.  The Court majority suggested a broad presumption against review of enforcement decisions.  In his concurrence only as to the judgment, Justice Marshall took issue with this presumption, arguing that the majority’s over-adherence to traditional principles of prosecutorial discretion contravene “one of the very purposes fueling the birth of administrative agencies”—the “reality that governmental refusal to act could have just as devastating an effect upon life, liberty, and pursuit of happiness as coercive governmental action.”  All agreed, however, that Heckler was an easy case on the merits.  
Three years after Heckler, the Court decided against the FDA in Berkovitz v. United States regarding the FDA’s discretion to institute action.  The Court endeavored to “restate and clarify the scope of the discretionary function exception” to the Federal Tort Claims Act.”  Having contracted a severe case of polio after ingesting a dose of Orimune, an oral polio vaccine manufactured by the defendant, the plaintiff sued the United States, alleging that the United States was liable for his injuries under the FTCA because (1) the Division of Biologic Standards (DBS), then a part of the National Institutes of Health, had acted wrongfully in licensing the defendant to produce Orimune and (2) the Bureau of Biologics of the FDA had acted wrongfully in approving release to the public of the particular lot of vaccine containing the plaintiff’s dose. The government filed a motion to dismiss on the ground that the suit was barred by the discretionary function exception to the FTCA.  The Court began by rejecting the government’s argument that the discretionary function exception precluded liability “for any and all acts arising out of the regulatory programs of federal agencies”; instead, the Court emphasized that the exception “applies only to conduct that involves the permissible exercise of policy judgment.”  With respect to the claim that DBS had acted wrongfully in issuing the license, the Court stated that the applicable statute and regulations require DBS, as a precondition to issuing a license, to secure test data from the applicant relating to the product’s compliance with regulatory standards.  The plaintiff’s allegations that DBS had issued the license without first receiving the test data thus stated a cause of action that was not barred by the discretionary function exception, because in so acting the agency would be violating a specific statutory and regulatory directive.  As for the claim against the Bureau of Biologics, because the FDA had adopted a policy of testing all vaccine lots for compliance with the standards and of preventing the distribution of any lots that failed to comply, the Court held that the release of the vaccines was not protected by the discretionary function exception because Bureau employees had knowingly approved the release of a lot that did not comply with safety standards.
E. FDA Jurisdiction
Closely related to judicial deference to agency action are the issues of the FDA’s jurisdiction and its relationship with the public health and safety regulatory efforts by state and local authorities.  In Hillsborough County, Florida v. Automated Medical Laboratories, the Court held that a county’s ordinances and regulations governing blood plasma centers were not preempted by the FDA’s regulations establishing minimum standards for blood plasma collection.  After rejecting the plaintiff plasma center’s argument that there was express preemptive language in the regulations, the Court also disagreed that the federal interest in the field and the breadth of the FDA’s statutory authority allowed implied preclusion of state laws.  Asserting that “the regulation of health and safety matters is primarily, and historically, a matter of local concern,” the Court dismissed the plaintiff’s evidentiary claim that the county’s ordinances would increase the costs of plasma production to the point of threatening the federal goal of ensuring an adequate supply of plasma.  In the context of the its standard for federal preemption, the Court was “reluctant in the absence of strong evidence to find a threat to the federal goal of ensuring sufficient plasma.”
Sixteen years later, the Court found implied preemption by the FDCA of state law claims in Buckman Co. v. Plaintiffs’ Legal Committee, which involved fraudulent representations to the FDA by a consultant to a manufacturer of orthopedic bone screws in the course of obtaining approval to market the screws.  The plaintiffs, patients claiming to have suffered injuries from implantation of the screws in their spines, had brought fraud-on-the-FDA claims under Pennsylvania state tort law.  In finding federal preemption, the Court explained that state-law fraud-on-the-FDA claims “inevitably conflict” with the FDA’s ability and responsibility to police fraud on itself—“complying with the FDA’s detailed regulatory regime in the shadow of 50 States’ tort regimes” would prohibitively encumber both the FDA and potential applicants.  Because the “very subject matter” of the manufacturer’s application for approval was dictated by the FDCA, no “presumption against preemption” existed, in contrast to cases where “federalism concerns and the historic primacy of state regulation of matters of health and safety” loomed large.  In other words, the very existence of the FDCA was “a critical element” in the plaintiffs’ claims by virtue of the defendant’s submission to and role in the FDCA framework.
In a similar situation involving the FDCA framework couched in state law, the Court in Merrell Dow Pharmaceuticals v. Thompson refused to find federal question jurisdiction over a state claim that was based in part on the theory that the defendant manufacturer’s alleged violation of the FDCA constituted negligence.  Speaking for the Court, Justice Stevens emphasized that the FDCA provided no federal cause action and that the Court would not create an “implied” private right of action.  Allowing federal jurisdiction for the state claim would functionally create a private right of action under the FDCA.  Moreover, the absence of a private remedy under the FDCA “is tantamount to a congressional conclusion that the presence of a claimed violation of the statute as an element of a state cause of action is insufficiently ‘substantial’ [a federal interest] to confer federal question jurisdiction.”  The Court rejected the defendant’s argument that state use and interpretation o the FDCA threatened the “order and stability of the FDCA regime.”  It suggested that such a concern was more suited an argument of FDCA preemption over state court jurisdiction.  Regardless of how the concern was couched, the Court was comforted by the prospect of its own ability to review the decision of a federal issue in a state cause of action, whether it came up through the federal courts or a state system.
The Court in FDA v. Brown & Williamson Tobacco Corp. grappled with what has been considered one of the FDA’s boldest assertions of jurisdiction and attempts at regulation: its promulgation in 1996 of regulations governing tobacco products’ promotion, labeling, and accessibility to children and adolescents.  A group of tobacco manufacturers, retailers, and advertisers challenged the FDA’s jurisdiction to regulate tobacco as customarily marketed: without manufacturer claims of therapeutic benefit.  They also specifically challenged the advertising regulations on First Amendment grounds.  Justice O’Connor, writing the majority opinion, found that the FDA had used its authority in a manner inconsistent with the FDCA and that Congress clearly had intended to preclude the FDA from exercising jurisdiction over the regulation of tobacco products.  Guided by “common sense as to the manner in which Congress is likely to delegate a policy decision of such economic and political magnitude,” the Court refused to read the drug provisions of the FDCA as broadly as the FDA did.  Justice O’Connor continually asserted that FDA jurisdiction over tobacco products could only result in their ban, a result that flew in the face of Congressional intent to keep the products on the market.  She restricted the FDA’s statutory authority according to somewhat of a logical extreme, asserting that though “consistent with the FDCA, [the FDA] may clearly regulate many ‘dangerous’ products without banning them,…what the FDA may not do is conclude that a drug or device cannot be used safely for any therapeutic purpose and yet, at the same time, allow that product to remain on the market.”  
	Though the Court in Brown & Williamson did not review the industry’s First Amendment claims, it was presented with commercial speech as the core issue in Thompson v. Western States Medical Center.  With the Justices sharply divided, the majority held unconstitutional provisions of the FDAMA forbidding pharmacy consumer-directed advertisements of specific compounded drugs.  The Court struck down the blanket prohibition on pharmacy advertisements of such drugs as overly broad in its prohibition of communication of advertising information useful to many from whom it might otherwise have been withheld.  In doing so, it acknowledged the concern that consumers may be misled by advertising into thinking that such drugs had not been FDA tested and approved, and noted that a less speech-restrictive alternative (e.g., an affirmative requirement in any such advertisement expressly acknowledging such compounded drugs are not FDA-approved for general use and may present undetermined risks), might well be sustained and remained available to Congress to enact. 

IV. Legal Ideals in the Court’s Jurisprudence 
	At the most general level, the Court’s jurisprudence in the area of FDA drug regulation can be gleaned from what the Court has deemed the statutory purpose of the federal drug laws and the statutory mission of the FDA.  Though the broad and perhaps most obvious purpose is to protect the public from unsafe and ineffective drug products, other goals having more to do with the well-being of the FDA, the industry, and democratic principles complicate any attempt at articulating a clear and singular purpose of the FDA and the laws.  These goals, beyond their grounding in any statutory readings, are also ideals embodying visions of how to justify and control FDA power.  In some contexts, these ideals are competing, while in others, they are largely consistent.  When they are competing, the Court often is not frank about it and legitimates one ideal while foreclosing or suppressing the others.  
A. The Prophylactic Public Health Ideal
	The first of these ideals is, of course, the public health ideal of the FDA.  Stated more broadly for all administrative law, it is the “public purposes” ideal, the central emphasis being the realization of valued public ends.  The ideal starts with a conception of the nature of the ends or purposes to be advanced by administrative action.  The ideal’s chief premise is that the primary standard for evaluating and criticizing the agency’s actions lies in its ability to carry out, and not to obstruct, the achievement of such a conception.  Overall, the public purposes ideal holds that the legitimacy of the administrative process turns on the agency’s ability to realize public ends in an effective and efficient manner.  Hence, the FDCA is “a working instrument of the government” and as a matter of statutory construction, not to be treated “merely as a collection of English words.”
	On one view, reflected most cogently in the New Deal conception put forward by James Landis, the public purposes to be achieved are those identified in an agency’s enabling legislation.  Formally known as the delegation doctrine, the basis for this view is the notion that legislative enactments are the legitimate repositories of the sovereign will and, therefore, their guidance of and limitations on the agency must be taken as paramount in identifying the public values to be promoted.  The allowable range of means for achieving these values is presumably well-defined and hence well-contained.
	A second, broader view expands the range of desired ends along with the allowable means of reaching them, not by expressly admitting to violations of the enabling statutes, but by assuming that broad delegations of power accord with the agency’s discretion to consider alternative goals and the widest possible variety of means for achieving them.  Cost-benefit analysis reflects this view on the principle that the right, or rational, course of action is one which maximizes social benefits while minimizing social costs.  This view places a greater deal of confidence in the agency and its ability to gauge and calculate the consequences of agency actions and to select a course of action that will maximize a more sweeping agenda of desired ends and minimize undesired results.
The Court has maintained both views.  In one example of the first view, the Court made one of its most confident assertions of the purpose of the FDCA and FDA in Rutherford: “Unless and until Congress do so, we are reluctant to disturb a longstanding administrative policy that comports with the plain language, history, and prophylactic purpose of the Act.”  In explaining its holding, the Court followed with a long list of hack panaceas and other products that gave rise to the federal drug laws, claiming that “this historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise.”  
In its cases establishing FDA enforcement authority, the Court has espoused the second view to give maximal effect to various statutory enforcement mechanisms.  For example, in Dotterweich, Ewing, Wiesenfeld Warehouse Company, and Park, the Court emphasized the needs of a public unable to protect itself from wrongdoing; hence, the prophylactic public health purpose of the Act foreclosed conventional requirements for criminal conduct and put the onus on those “otherwise innocent but standing in responsible relation to a public danger.”  In addition to special remedies such as factory inspections and multiple seizures, the Court’s expansion of corporate criminal liability gives the FDA a wide and deep range of enforcement measures.  Also, this version of the public health purpose suggests one major alternative public goal—a substantial degree of industry self-regulation.  I will explore this goal further in my discussion of what I consider a “counter-ideal” of FDA regulation.
The majority opinion in Brown & Williamson stressed the same prophylactic purpose of the FDCA: “The FDCA’s misbranding and device classification provisions make evident that were the FDA to regulate cigarette and smokeless tobacco, the Act would require the agency to ban them.  In fact, based on these provisions, the FDA itself has previously taken the position that if tobacco products were within its jurisdiction, ‘they would have to be removed from the market because it would be impossible to prove they were safe for their intended use.’”  Accordingly, the majority pinned the FDA’s discretion into an impossible situation: “What the FDA may not do is conclude that a drug or device cannot be used safely for a therapeutic purpose and yet, at the same time, allow that product to remain on the market” because such a move “is incompatible with the FDCA’s core objective of ensuring that every drug or device is safe and effective.”  Justice Breyer, in his dissent, adopted a expanded, more “inclusive” conception of the prophylactic purpose: “[T]he statute’s basic purpose—the protection of public health—supports the inclusion of cigarettes within its scope,” linking with the majority opinion in Bacto-Unidisk, where the FDCA was “to be given a liberal construction consistent with [its] overriding purpose to protect the public health.”  Hence, Breyer argued that the FDCA does not limit the FDA’s remedial alternatives to a complete ban on tobacco products.    
	Justice Powell, concurring in Hynson, provided another formulation of the public health purpose of federal drug regulation.  He explained that the 1962 Amendments specifically provide for a hearing in “new drug” application withdrawals “[to] provide protection against such [arbitrary agency] action” especially in a statutory scheme where the FDA is vested with legislative, judicial, and prosecutory responsibilities.  Further underlying the hearing requirement was a “two-fold” public interest: “(i) to remove from the market, in accordance with due process, drugs of no utility or effectiveness; and (ii) to retain on the market those drugs that are efficacious.”  He continued, “In an understandable zeal to remove the former, an administrative agency must not overlook both the interest of the public and the right of the proprietor in protecting the drugs that are useful in the prevention, control, or treatment of illness.”  Instead of focusing on the language of the statute to severely limit the FDA’s remedial alternatives, Justice Powell recognized the complexity of regulation in terms of the needs and vulnerabilities of the regulatory world’s participants.  
B. The Agency Self-Legitimation Ideal
	Justice Powell’s concurrence in Hynson highlights another ideal: the FDA itself and its function as a federal administrative agency.  Though this ideal may not be as obvious from the statute as the public health purpose, certainly the overall framework of the FDCA and the very existence of the administrative state call for a great and continual measure of legitimating the FDA’s internal functions.  In other words, the FDA has to be legitimated by how it carries out its purpose and why it should be entrusted to do so, apart from Congress’ delegation of power and purpose.  Though this “self-legitimation” ideal in large part furthers the public health ideal, it is separate in that certain versions of it either conflict with or foreclose certain versions of the public health ideal.  The Court has articulated this ideal throughout the above cases, most frequently through an appeal to the expertise and experiential value of the FDA.
	Expertise theorists picture an administrative bureaucracy as a “natural community” organized to pursue a common purpose and disciplined by standards mandated by “professionalism.”  But perhaps most important to the expertise theory are the “community’s” profound internal cohesion among members, and loyalty to the bureaucracy’s leadership and its collective mission.  The bureaucracy, to be effective, must internalize as part of its collective consciousness the common purpose that unites its members.  The members’ daily activities will both define and be defined by this common purpose.
	In expertise theory, “professionalism” plays an integral role in sustaining relationships among members of the agency as well as the relationship between the agency and those whom it regulates and serves.  Agency heads, agency employees, and the public are not adversaries but collaborators in a joint venture: all share the goal of advancing the public interest, or in the FDA’s case, the public health.  Yet, the role of the agency in this joint venture is largely elevated and defined by the public’s acceptance of the agency’s decisions on matters within its expertise.  The agency’s purpose and self-legitimating premise is its exercise of its expertise, and its judgments are trustworthy because they are based not on personal or political factors but on the common purposes shared by the government and the public.  Indeed, the public and other branches of government are disqualified from reviewing bureaucratic decisionmaking because they all lack the ability to second-guess the complex judgments that enter into such decisionmaking.  No one else has the right instincts and loyalty to the right self-regulating standards that can give concrete meaning and power to the agency’s purpose.  In place of control from the outside, the expertise model instead exerts a stricter, more exacting, and somewhat self-absorbed control from the inside.
	For the FDA and drug regulation, the Court has developed two basic elements to this expertise ideal: the FDA must exercise judgment and must exercise it objectively, or “impersonally.”  The legitimating basis of FDA “judgment” is the assurance that the FDA exercises of discretion are rational and informed.  The objective ingredients of a rational and informed judgment do, to some extent, eliminate some subjective discretion, but legal doctrine and purportedly objective scientific guidance imply that discretion can be sacrificed without detriment to the agency’s bureaucratic operations.  On the other hand, the subjective discretion allowed by such “judgment” precludes the imposition of some objective constraints, but legal doctrine assumes that these constraints can readily be omitted.  After all, the Court has consistently held that various forms of arbitrariness must be protected against, while at the same time protecting agency discretion against excessive restraints. 
	From its “matter of opinion” notion in the early part of the twentieth century, the Court has come a long way in recognizing expertise as a legitimating ideal of administrative power.  Though McAnnulty dealt with the Postmaster General statute and not the FDA, it heavily influenced the outcome and reasoning of Johnson.  The fact that the Bureau of Chemistry of the Department of Agriculture was delegated authority over “misbranding” may also have led the Court to hesitate to defer to the Bureau over therapeutic effects of drug products—though the Bureau was well-equipped to ascertain and confirm the identity and composition of such products, it was “hardly so as to medical effects.”  Overall, the Court assured that claims of “medical effects” were not matters of fact, but an area “where opinions are far apart.”  The Bureau could not have exercised objective, rational, and informed judgment.
	Through the development of the federal drug laws as well as the expansion of the administrative state, the Court accordingly changed its tune.  The Court made the most confident use of the expertise ideal in Rutherford, where it asserted that deference to the FDA “is particularly appropriate where, as here, an agency’s interpretation involves issues of considerable public controversy, and Congress has not acted to correct any misperception of its statutory objectives.”  The Court readily acknowledged and even stressed the highly charged political debate over access to drugs for treatment of the terminally ill, but trusted the FDA’s experience in the area.  The FDA’s consistent interpretation of the Act was enough to overcome the continuing public debate and was evidence that the FDA was repeatedly arriving to the same conclusion in a rational and informed manner.  Similarly, in Bacto-Unidisk, the Court rejected any attempt at controverting the FDA’s determination that the “drugs” at issue posed public health dangers.  Satisfied that the “expert agency charged with the enforcement of remedial legislation has determined that regulation is desirable for the public health,” the Court humbly conceded that the Court itself, as well as the litigants, were “hardly qualified” to question the FDA’s medical and policy judgment.
	Another important component to the Court’s expertise ideal is the notion of an FDA expertise that is independent from the expertise of professions intimately involved with the drug regulation—it upholds a different “rationality” informed by considerations that non-FDA physicians or scientists did not have to account for in the medical or scientific profession’s “rationality.”  In holding what the medical profession would have considered a “device” to be a “drug,” the Court in Bacto-Unidisk concluded that Congress intended to define “drug” far more broadly than the medical profession does.  A broader definition was essential to maintaining the integrity of the FDCA’s remedial purpose and the FDA’s dual expertise of interpreting its enabling statute and ensuring the safety and effectiveness of antibiotic products.  The medical profession did not need a broader definition of “drug” because it did not have to administer a regulatory scheme.
	In another, more condemnatory examination of the medical profession, the Court in Hynson foreclosed physicians’ judgment from the relevant expert community.  In discussing the contours of the “substantial evidence” standard of drug effectiveness under the 1962 Amendments, the Court asserted that the “well-established principles of scientific investigation” involved in the standard barred “anecdotal evidence indicating that doctors ‘believe’ in the efficacy of a drug.”  Such “impressions of beliefs” of physicians were “treacherous.” and had no place in the regulatory scheme.
	In other instances, however, the Court buttresses FDA decisions with expert testimony from physicians.  The Court in Rutherford catalogued a number of statements made by non-FDA medical experts in support of the FDA’s decision not to exempt Laetrile from its safety and effectiveness standards.  Similarly, deference to the FDA in Bentex Pharmaceuticals was warranted partially by the fact that the “substantial evidence” standard was based on consensus “among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs.”  Thus, the standard is “peculiar” to the FDA’s “administrative expertise.”  Accordingly, courts are wise to stay their hand in “evaluation of conflicting reports as to the reputation of drugs among experts in the field.”  Overall, the Court asserted that scientific expertise not only legitimates the FDA’s authority over the legal interpretation and scientific administration of “new drug” applications, but also insulates it almost completely from judicial review.
As for conflicts among experts, the Court first adopted a functional, “progressive” approach in Reilly, where it refused to extend the McAnnulty “matter of opinion” reasoning to situations where medical experts had not demonstrated that particular claims of curative effects were false.  Both the government and the industry constituted a “crucible of experience” where “experimentation is the spur of progress.”  The Court imagined progress in medicine as a cooperative venture, where the government could not “condemn new ideas as fraudulent solely because some cling to traditional opinions with unquestioning tenacity”; such a power would “amount to a condemnation of new ideas without a trial.”  
The Court employed a functional approach to distinguish between FDA expertise and non-FDA expertise in Flemming, where it held that the Secretary of HEW and FDA had scientific standards and concerns distinct from those of the industry.  Rejecting arguments that the government had to test the human toxicity of certain artificial colorings, the Court did not believe “that Congress required the Secretary first to attempt to analyze the uses being made of the colors in the market place, and then feed them experimentally only in the proportions in which they appeared in certain of the food products in which the colors were used.”  Furthermore, this divorce of agency expertise from non-agency expertise was one of the background purposes of the FDCA.
In another case dealing with dissent among experts, the Court employed a strongly formalist approach in virtually endorsing one expert over another in Forsham v. Harris.  The Court held that raw data produced a private group of physicians and scientists performing studies of diabetes treatment were not “agency records” subject to disclosure under the Freedom of Information Act (FOIA) even though the group had received study grants from the Department of Health, Education, and Welfare (HEW) to conduct studies and the HEW had the authority to obtain the data had it chosen to do so.  In addition, the data formed the basis of published reports that were later relied upon by the FDA in issuing proposals regarding the labeling on diabetes-treating drugs and the eventual withdrawal of one drug from the market.  The Court’s public/private distinction marked a line between two expert communities, a “private” one not required to disclose, and a “public” one subject to the same disclosure requirements as the FDA.  This line has important implications for any notion of “consensus” as a legitimating premise for FDA authority, for it necessarily means that in areas where the scientific issues are as riven as the moral or political ones, the FDA must choose one “expert” view over another, though both may be more or less equally compelling.  The line complicates expertise theories that pursue the elements of “judgment” and “rationality” in bureaucratic exercises of discretion.
C. The Democratic Process Ideal
	The third ideal focuses on the public, those served by the administrative process.  The basic vision underlying this ideal is of a highly participatory decisionmaking process, either by representation or through direct participation.  Agency officials are held accountable for the extent to which they actively take into account the views of affected groups in formulating and implementing agency policy.  
	This third ideal differs from the public purposes and agency self-legitimation ideals in a number of ways.  First, unlike the self-legitimation ideal, this democratic process ideal does not put primary emphasis on the expertise of administrative agencies or on the instrumentalist bent of their decisionmaking. Instead, this ideal frames administration mainly as a political process.  Similarly, it differs from the public purposes ideal in that it does not focus on the statutory aim of the agency, but in how the agency embodies or reflects public perceptions and concerns in its decisionmaking.
	The participatory vision of the democratic process ideal requires for its full realization that the institutions in which it operates be governed by premises of responsiveness to the public to the point where the public are effectively participants in the decisionmaking process.  Though this ideal may not have been as important a part of original conceptions of the administrative state, the Court has continued to suppress an even moderately powerful version of the democratic process ideal; the public purposes and self-legitimation ideals dominate the Court’s administrative law jurisprudence.  Integral to this process of theoretical suppression is the Court’s image of the public as helpless and in need of non-democratic supervision and realization of public values.  With a few exceptions, this is the primary thread through the above cases.  Hence, the democratic process ideal is a powerful critical lens that brings the hegemony of the public purposes and self-legitimation ideals into question.
	The Court’s deference to the FDA in Rutherford over issues of “considerable public controversy” perhaps is the clearest example of foreclosure of the democratic process ideal—faith in expertise excuses the need for public deliberation.  Though not speaking directly to this point, Forsham suggests this foreclosing move by the dominant ideal—deference to expertise—over the suppressed democratic process ideal.  Holding the study not an “agency record,” though it had been funded by HEW and relied upon by the FDA in an administrative action, the Court effectively insulated it from public scrutiny.  As the dissent pointed out, the subject and the conclusions of the study were controversial, all the more because it partially resulted in the suspension of the new drug application for a diabetes-treating drug.  Particularly telling is the Court’s reasoning that though HEW could have obtained the study, disclosure under FOIA only applied to records that an agency had actually accessed.  A record becomes an “agency record” only until the agency’s fingerprints are on it.  The Court stressed that the FOIA does not impose a duty on agencies to create “agency records”; such a provision would infringe on the integrity of the agency as an expert, self-governing unit.  Forsham also sought to protect non-government expertise as well.  Though the FOIA was meant to increase public access to governmental records, “grantee autonomy” had to be preserved as well. 
	In Merrell Dow, the Court refused to read a private right of action into the FDCA at the same time it held that a state negligence claim, though involving an allegation of FDCA violations, did not present a federal question.  Congressional intent was at best unclear on both issues, and no compelling federal interest warranted the claim going into federal court.  The Court also dismissed the arguments that the stability of the FDCA regime warranted federal jurisdiction over the claim.  Justice Brennan, dissenting, emphasized that the FDA has no independent enforcement authority and that in fact final enforcement had to come from the federal courts, which had exclusive jurisdiction over actions brought under the FDCA.  “Thus,” he continued, “while the initial interpretive function has been delegated to an expert administrative body whose interpretations are entitled to considerable deference, final responsibility for interpreting the statute in order to carry out the legislative mandate belongs to the federal courts.”  Though Justice Brennan seemed to agree with the majority that the FDCA did not contain a private right action, he strongly disagreed on the issue of whether a federal court had jurisdiction over the state action.  Availability of federal jurisdiction would realize “Congress’ strong desire to utilize the federal courts to interpret and enforce the FDCA.”  He found that federal jurisdiction over state actions brought by private complainants is consistent with FDA public enforcement, in that both reflect “congressional concern with obtaining more accurate implementation and more coordinated enforcement of a regulatory scheme.”
The majority in Merrell Dow, employing a strict formalist test of determining federal jurisdiction for state claims and reading Congressional intent from the FDCA very narrowly, adopted a restricted version of the public purposes ideal to foreclose both a private right of action and federal jurisdiction over a state claim involving allegations of FDCA violations.  Justice Brennan suggested that a somewhat muted version of the democratic process ideal (private citizens bringing state law claims involving the FDCA to federal court) could serve the public purposes ideal.  Both agreed that a private right of action should not be part of the regime, with the background understanding that it would subject the industry to a limitless universe of private enforcement decisions as well as public enforcement; given the nature of drug research and investment, the availability of an FDCA private remedy would most likely stultify the industry and run counter to both the public purposes and democratic process ideals.
	Though largely consistent with the Court’s predisposition in Merrell Dow, the reasoning in Berkovitz carved out an exception for situations in which the FDA itself may have harmed or played a major role in harming the public.  In holding that the discretionary function exception to the FTCA did not bar a claim alleging that the FDA had not followed its own vaccine testing policies, the Court imposed a substantial degree of accountability on the FDA and need for responsiveness to the public for its own actions.  When the FDA had restricted its own exercise of discretion, the public could hold the FDA to that self-restriction.  As a rule, the Court asserted, “[I]t is the nature of the conduct, rather than the status of the actor, that governs whether the discretionary function exception applies in a given case.”  Regarding agency decisions not involving policy discretion, the Court abandoned the expertise theory and gave less force to the self-legitimating “expert” status of the agency.  In turn, the agency exposes itself to public scrutiny (and lawsuit) and is functionally stripped of agency status when failing to follow either Congress’ or self-imposed policy parameters.
	In the area of commercial speech, the Court has employed a version of the democratic ideal to limit or at least complicate a strong version of the prophylactic public health ideal.  In Western States Medical Center, Justice O’Connor, writing for the majority, asserted that the government has no interest in “preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.”  In holding unconstitutional provisions of the FDAMA that prohibited advertising of particular compounded drugs, the Court placed greater faith in the doctor-patient relationship than the government had argued in the case.  Adopting language from Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, O’Connor preferred over a “highly paternalistic approach” an alternative that rejected any assumption that the advertising was inherently harmful, and “that people will perceive their own best interests if only they are well enough informed.”  To reach that end, moreover, the government had to “open the channels of communication rather than to close them.”  Overall, the Court placed greater faith in the public’s ability to fend for itself.  Furthermore, in contrast to language in Bacto-Unidisk and Hynson, the Court found that both the industry and the medical profession had sufficient expertise and trustworthiness to be free of commercial speech restraints in the promotion of compounded drugs.  Western States is one indication of the Court’s view of commercial speech as promoting the interest in public decisionmaking in a democracy.  The question of whether invalidation of Congressionally-enacted legislation furthers that view (as well as the pro-regulation public health ideal) is more controversial.

V. Preliminary Conclusions
	In this section, I suggest a few insights gained from a critical examination of the above ideals.  Though I do not provide much in the way of specific policy prescriptions, I offer a few considerations crucial to constructing a stronger version of the democratic process ideal and an alternative vision of the relationship between government regulator and regulated industry.  As a general matter, I share in the view that a legal ideal can receive not just one meaning but a host of alternative institutional embodiments, each of which guides formal rules and social practices in varying ways.  It is with this variety of “embodiments” of any one legal ideal that we decide whether to accept, reject, or revise the legal ideal as it exists in the status quo.  Accordingly, legal interpretation becomes a truly interactive and interdisciplinary practice that demands continuous, critical examination of varying accounts of the text and the past.  
A. More Consideration of Democratic Process: Public Participation
	“As the administrative authority is within the reach of the citizens, whom in some degree it represents, it excites neither their jealousy nor hatred: as its resources are limited, every one feels that he must not rely solely on its aid.  Thus, when the administration thinks fit to act within its own limits, it is not abandoned to itself, as in Europe; the duties of private citizens are not supposed to have lapsed because the state has come into action; but every one is ready, on the contrary, to guide and support it.  This action of individuals, joined to that of the public authorities, frequently accomplishes what the most energetic centralized administration would be unable to do.” –Alexis de Tocqueville, Democracy in America

To reiterate, with a broad view of federal drug regulation’s purpose of protecting the public health and legitimating the FDA itself, the Court still forecloses a key theory and aspiration of drug regulation.  Altogether, they are the democratic goals of regulation—the ability and necessity of lay people to participate, in a sufficiently informed way, in the processes of government.  The concentration of regulation in administrative agencies has hindered democratic deliberation both in localities and in the private sphere.  This concentration has also contributed to the power of well-organized, well-funded, and well-connected interest groups over the regulatory process.  But even without the presence of powerful interest groups, placing too much stock in the traditional arguments for administrative centralization often blinds regulation from its true objects: serving the public as well as including the public in governance.
	For example, when examining the Court’s expertise and public purposes justifications in Rutherford, we must recognize that deference to the FDA over such issues as the availability of drugs for the terminally ill assumes that the FDA in fact is responsive to the public and takes into account the non-expert, non-scientific arguments and ramifications of such issues.  Summarizing the legislative history and the history of the FDA’s administrative interpretation as to the issue does not answer the question but only further begs it.  Is it acceptable that the FDA came to its interpretation of the statute by virtue of its scientific expertise, or should we more critically examine the agency’s ability, and perhaps its obligation, to advance public values through means external to its own organic justifications?  
	The challenge is to identify norms on which people might be persuaded to agree.  It requires policymakers as well as judges to make value judgments while making some assessment of the judgments’ role in improving or impairing the operation of statutory law.  The choice of norms will call for value and policy judgments to the extent that formalist approaches to statutory construction are incomplete or inappropriate.  Accordingly, these interpretive norms will be valid only to the point that good substantive and institutional justifications can be made on their behalf.  In the end, one of the major interpretive norms in realizing the democratic process ideal may be the faith in agency expertise, as in Rutherford, but the critical project is to reevaluate these norms in their current institutional embodiments.  For example, perhaps upon greater deliberation we may conclude that the democratic process ideal is better expressed and carried out by a joint vision of agency and industry expertise.  
Attention to this challenge of identifying interpretive norms and assessing their institutional embodiments is especially crucial to the evaluation, acknowledgement, and maintenance of public trust in regulation and regulatory bodies.  An understanding of the mechanisms of creating trust is essential to more effective regulatory policy.  As this trust between government and public develops, opportunities for cooperative efforts at regulation between government and industry and self-regulation within the industry become more attractive and feasible.
	Public perceptions of risk are filtered through judgments about the dependability of the entities charged with responsibility for detecting and managing those risks as well as the benefits of risky activities.  For example, the public primarily may view the riskiness of consuming a particular drug not based on the endorsement of the FDA, but on the information provided by the medical profession or the research department of a drug company.  The crucial issue here is that despite the formal regulatory role of the government, the public may base individual decisions more on risk detection and management by the industry or independent professions.  This variance in public risk perceptions is crucial to framing the legal rules and imagining the players involved in drug regulation.  Indeed, this variance echoes the “matter of opinion” notion in the early cases of McAnnulty and Johnson, and certainly resonates through even the most recent Court opinions, such as in Western States Medical Center.
	Accordingly, the Court and the FDA must understand the dynamics of trust building in order to develop more effective regulatory policy.  Negative events grab hold of the public’s imagination more quickly and intensely than positive events; certainly, media coverage tends to emphasize the former.  The FDA’s internal expert evaluations of risk should not dominate policy determinations to the neglect of lay ones; indeed, this only exacerbates the problem and the essential disjunction between expert and lay risk perceptions.  Moreover, the greater prominence agency risk analyses carry in formulating policy, the more detached such policy becomes from public understanding and response.  Such an effort could undermine itself by destroying the public trust necessary to make policy work. 
	Another dimension of public trust is the relationship between judicial review and agency regulation.  Beneath the surface of the various interpretations of the FDCA, the Court seemingly neglects the very people that it continually claims to protect.  Assertions of Congressional intent and statutory purposes foreclose the public’s point of view, its own self-image, and the transformative potential in viewing the “protected” public as an active participant in the drug regulation field instead of a passive recipient of governmental know-how and enforcement.  Common arguments for the expertise of administrative agencies and the especially scientific nature of FDCA regulation are helpful in upholding the FDA’s authority, but often are beside the point—the pivotal question, and perhaps what should be the aim, of drug regulation is if and how individual citizens can live independently and make informed choices about consumption of FDA-regulated products.  The key to this question is not a set of technical legal doctrines, but a recasting of the FDA’s purpose (not limited to its “statutory” one), images of the public as a beneficiary of FDA regulation, and the possibilities for cooperation within and among the FDA, the public, and the industry.
Indeed, the dominant view of drug regulation and drug laws insists on deference to legal norms.  In Abbott Laboratories, the Court placed great faith in the courts to handle challenges to agency regulations.  Within the ambit of judicial review, courts could employ procedural rules such as venue transfer, abstention, and equitable defenses to injunctive and declaratory relief to mitigate the fray between agency and industry.  The Court did not consider how the availability of judicial review and these legal rules would affect the responsiveness of both agency and industry to public needs.  Overall, the term “public interest” is thrown around almost indiscriminately, without much concern for how judicial review essentially affirms that the source of social power resides in the government (or more specifically, the judiciary) rather than in the public.  And so from there, it is all up to the government whether to recognize and realize the legitimacy of public values or just end up reinforcing the very social conditions that certain popular movements, such as consumer movement, originally sought to transform.  The latter often happens so subtly that the popular movement is destabilized without the movers even knowing it.  The Court’s biggest tools in this process are various legal doctrines couched in Congressional delegations and exhortations of administrative expertise, the limitations of which are artfully shrouded or more often legitimated through other thorny doctrines without being frank about the true socioeconomic and political foundations and immediacies of legal disputes.  
In two other examples, the Rutherford and Brown & Williamson courts took the prophylactic public health ideal to heights of statutory interpretation that defeat the value and power of FDA regulation as an opportunity for public discourse.  Indeed, such a narrowing of the public health purpose along textual “norms” conflicts substantially with the Court’s historically considerable deference to the FDA and the “purposefully broad delegation of discretionary powers by Congress” to the FDA.  The public health ideal of Rutherford and Brown & Williamson lies strictly in the protection of the public health, and less a progressive notion of improving the public health.  Within the government, pigeon-holing the FDA flies in the face of both the history of the agency and Congress’ appreciation of the FDA’s self-handling.  Though the Brown & Williamson majority readily acknowledged that tobacco use is “one of the most troubling public health problem facing our Nation today,” it did not account for the advantages of the FDA’s regulatory flexibility in dealing with an issue of such magnitude.  As for democratic ideals, though the FDA engages in a variety of educational and public service efforts promoting certain practices, handcuffing the FDA’s statutory regulatory authority puts a dent into the FDA’s relationship with the public and the opportunity for the public to react to and shape a broad variety of federal regulatory alternatives.  
I do not, however, go so far as condemning the Court as a vehicle of “deception” and “human domination” that overruns individual autonomy with government fiat.  In my critical view of the Court’s jurisprudence, what are deemed technical legal “norms” no longer hide the deep structural underpinnings of a jurisprudential ideal.  Exposing these underpinnings shifts the borderline between what is deemed wrongful in a legal dispute and the background to that wrong.  In particular, such a strategy understands the law not as dealing with individual social atoms that combine or clash in moments of private ordering or dispute, but as deeply embedded in large-scale, complex bodies of social planning, official and unofficial, whose structure contains much of social life.  These bodies, such as the courts and the FDA, possess not only demonstrable power to organize and perpetrate large-scale wrongs, but also great potential to restructure behavior in line with ideals arrived at by meaningful public deliberation.  Accordingly, the Court, both as a forum for dispute resolution and deliberation of public values, must be candid about whether certain legal norms effectively address the political problems inherent in the legal disputes before it.  Often, this may mean that the dispute should return to the FDA itself, and be resolved by people who are closer and arguably more responsive to the political immediacies of regulation.
	The major complication with a greater focus on democratic ideals in drug regulation is the absence of a distinct, united consumer movement—a recognizable group of people or coalition of groups, mobilized to act, with a resource base and a set of objectives.  Though consumers, as a constituency, may not be as distinct or consolidated as the drug industry or medical profession, this does not mean that no one speaks for consumers or that possible inequities or difficulties in the consumer’s role go unnoticed.  Consumer voices are heard at various levels in the government, both elected and bureaucratic, through the press, and in club meetings and lecture halls.  Public figures and perennial candidates for major offices like Ralph Nader are committed almost solely to representing general consumer interests.  
More important is the problem of how the lack of a unified, uniform consumer movement affects a statutory purpose couched in the “public interest.”  Undoubtedly, the Court and the FDA deal with a variety of consumer constituencies voicing different, conflicting needs and expectations of the government.  No more is the Madisonian ideal of the “public interest” as an overarching, autonomous solution to problems free of politics and something greater than and above the sum total of private interests.  Instead, the “public interest” is essentially “privatized” by different groups jockeying for position in the political arena and the courts.  Along with this democratic pluralism comes a disaggregation of “public” goals and agendas.  Correspondingly, the privatization of the “public interest” moves closer to understanding rights and entitlements as group-based and their infringement as the result of systemic mechanisms and government prioritization, which is subject to both legitimate and less savory influences.
So, how does the Court itself, as a body that defines public values as well as the limits of governmental authority, deal with this “privatized” reality of the public interest?  I believe that the first steps are to celebrate it, reconceive the matrix of relationships in the regulatory world, and frankly admit the disaggregation of the “public interest.”  The real problem is how to develop an institutional analysis that allows us to synchronize the competing rights of groups as well as individual rights vis-à-vis the government.  The Court must be ready to admit that competing rights situations and real conflicts between the individual and the community may not yield a “coherent” whole.  The conflicts may be mediated and synchronized but not eradicated.  Moreover, the point of this reconception of the regulatory world is not to satisfy the substantive needs of every individual or group possibly affected by a decision, but at least to recognize those that are often forgotten or foreclosed from discussion.  
From there, previously unknown or non-existent groups and coalitions of groups may surface—no more will such groups be engulfed into one illusory “public interest.”  These groups may go out on their own or seek relationships with others.  Groups with already salient voices, such as the Green Party or the American Association of Retired Persons, may gain potential allies or face new adversaries; regardless, new emerging voices serve to sharpen their platforms.  Political activity will break through the “private” walls within these groups and spill into concourse with other groups.  The power of the Court’s recognition is “to stretch the human imagination so that the I of private self-interest can be reconceptualized and reconstituted as a we that makes possible civility and common political action.”  Especially in a regulatory world where the industry and medical/scientific professions are well-organized (though certainly even these players are disaggregated to a substantial degree) and resourceful due to the enormous stakes in investment and professional identity, greater governmental recognition of less visible, less vocal constituencies will be invaluable to augmenting the democratic ideals of regulation as well as to bringing more meaningful advocacy and data to the process of regulation.  Instead of continually referring to what it often deems a singular “public interest” involved in regulation of drug products, the Court, even if just by its language, can spur greater political activity by a greater number of people.  Such a move realizes the Tocquevillian vision of a partnership between government and citizenry, a vision that reinforces and ennobles core democratic values of community, pluralism, and participation.  
This greater recognition of interest groups is a crucial condition to a meaningful attempt at formulating an aggregate “public interest.”  At first glance, the relationship between private interest groups and an overall public interest seems paradoxical, when considering that the latter eschews the primacy of private interest in favor of a common good.  The tension, however, is not so troubling when viewing the formation and identification of private interest groups as part of a collective deliberative process.  The political role of these groups within the administrative state is to debate the common good from their individual perspectives, and not inflexibly to pursue their private concerns.  
B. Yet More Consideration of Democratic Process: Public Rights
A critical examination of the Court’s treatment of the democratic process ideal also reveals how administrative law, and in particular the federal drug laws, have created a new set of public expectations and “rights.”  Congressional intent and statutory purpose are the be-all and end-all of the Court’s examination of the federal drug laws.  Yet, these venerable, time-tested interpretive canons should not constitute the sole inquiry, as the laws involved have created and continue to create expectations from the public that they are designed to protect.  These expectations are different from those rising out of common law entitlements or even “natural law” tenets.  They exist only because the government, through the administrative state, has created them—with this creation comes the promise of enforcement.  Taking into account and even adopting public expectations satisfies both the narrow, seemingly objective requirements of statutory interpretation as well as the broader substantive aims of the drug laws.  It promotes the values of order, fairness, and democracy, as the definition of law, and especially of government regulation, can neither be served from these values nor subsumed within them.  
The most powerful “public” right in the drug regulation context is centered on the public’s need to know what it is purchasing.  This need, and the right to have this need satisfied by both the government and the industry, hinges a great deal on the accuracy of information.  If goods are honestly and fully labeled, consumers would know what they needed to know and could indeed judge for themselves the character of the goods they purchase.   Such is the idea behind both the majority and dissenting opinions in Western States Medical Center.  Market forces would work to regulate the quality of goods available if consumers had access to the information they needed to make informed choices.  
Underlying this “public” right is another more fundamental aspect of the need to know.  Consumers need to know if drug manufacturers can be trusted, and with what they can be trusted.  Ultimately, the existence of this public trust lies in the industry, but the Court and the FDA have done a great deal in creating and maintaining legal mechanisms that uphold this element of the consumer’s need to know.  The Court’s jurisprudence in this area has come to the point where the industry, and especially corporate officers, “voluntarily assume” this public trust.  In turn, the public “supports” the industry through its patronage. 
Another, perhaps more readily troubling aspect of “rights” in this area of jurisprudence is the Court’s somewhat limited notion of what is appropriate constitutional discourse when dealing with administrative action.  For example, in Heckler, the Court warned, “The fact that the drugs involved in this case are ultimately to be used in imposing the death penalty must not lead this Court or other courts to import profound differences of opinion over the meaning of the Eighth Amendment to the United States Constitution into the domain of administrative law.”  Though all the Justices may have agreed Heckler was an easy case on the merits, a more controversial instance of agency inaction can easily implicate Eighth Amendment protections.  In the constitutional context, this language in Heckler suggests that the Court at times slips in and out of consciousness with regard to protection of constitutional rights in the midst of resolving administrative law issues.  Central to this consciousness is a realization that governmental choice, both action and inaction, amount to decisions.  An agency’s failure to act can be seen as a “subsidy” to those who benefit from the inaction.  On the other end, those hurt by agency action are deprived of a “public” right, such as a right to determine the effectiveness of a drug for a particular purpose.  Because administrative law doctrines are inextricably wound up in “public” rights and expectations, perhaps even of constitutional dimension, a construction of administrative law as immune from constitutional “rights” discourse could be fatal for a slew of civil liberties and consumer power vis-à-vis both the government and the industry.    
As for what are arguably constitutionally protected abortion rights in Benten, what are the implications of the Court not passing on the due process issue—does the prophylactic public health ideal account for abortion rights?  As part of a “public” rights regime, an alternative or even a corollary to the prophylactic public health purpose is that the public has a right not only to safe and effective drugs (as well as accurate and full information), but also to drugs that one needs either to fulfill a constitutional right or even a government-created “public” right that may not have been part of the original conception of a regulatory scheme, but has developed as part of an “expectation” arising from the scheme.  Inherent in the idea of “public” rights is an expectation of deliberation and involvement by the public in how the rights are defined and developed by the government.   
C. Attitude Toward the Industry
	Business, government, and the public are often spoken of as if they were distinctly separable entities, often in direct conflict with one another.  They are portrayed to have some functional overlaps and interdependencies, but with sharply different interests and memberships.  When business leaders serve in government positions or when former politicians enter employment in the “private sector,” there are both murmurs and cries of conflicts of interest.  Decisions or policies “won” by consumer protection groups or “public interest” organizations are seen as “defeats” for business.  Moreover, the government in these situations is seen as either “anti-business” or “anti-public.”  
	This adversarial arrangement pits government and industry against each other as virtual enemies, and suggests that the principal interests of these two major sectors are often directly at odds.  Business’s profit-seeking may be seen as necessarily clashing with government’s mandate to protect the public health.  Business’s efforts to operate efficiently may run counter to the government’s relative freedom from market pressures as incentives for efficiency.  At the core of these images is the assumption that the government is the sole protector, or even representative of the public.
	Most of the Court’s drug regulation jurisprudence adopts this adversarial model.  In Antikamnia, the Court interpreted the PFDA according to what it deemed a long history of suspicion and distrust of drug manufacturers: “It was this experience that the law sought to avail itself of and to avail itself against the ever-increasing powers of the laboratory or the disguises of a technical nomenclature.”  Interestingly, this language suggests an anti-expertise justification for the PFDA, or at least a version that distinguishes between agency expertise and non-agency expertise.  In USV Pharmaceutical, the Court found “no persuasive reason to resolve the ambiguities in favor of the manufacturers” when deciding whether “me-too” drugs were subject to the efficacy requirements of the 1962 Amendments.  Without regard to the pro-public ramifications of an interpretation “in favor of the manufacturers,” the Court was not shy about what it considered an argument solely for the industry or solely for the government.
	One alternative vision of the regulatory world frames the industry and government as a partnership in which the two are intertwining and complementary.  They strive for the same basic goals with each benefiting substantially from the activities of the other.  Certainly, medicinal innovation and product safety are among the most important of the common goals.  Government in this model is seen as a working partner, or least a player willing to cooperate instead of jumping the gun of enforcement, especially when agencies such as the FDA have special remedial measures more draconian than traditional civil and criminal penalties.  Also, the industry is expected to exercise a greater degree of self-regulation, partly in response to the government’s authority, but more importantly, in pursuit of benefiting the consuming public.
Product recall is one measure that may be particularly amenable to this alternative vision of partnership between government and business.  If the FDA can order recalls independently of the courts, both the FDA and the industry will share a sense of urgency that a potentially hazardous product should be removed from the marketplace.  At the same time, recalls are less intrusive than FDA seizures; moreover, the FDA itself is less burdened when not having to do administer individual seizures of a product that is dispersed throughout the country.  In addition, the industry may prefer recalls to broad FDA rules and regulations because recalls generally affect only the makers of offending products rather than the entire industry.  Recalls, unlike standards or regulations, do not impose across-the-board certification, registration, or disclosure requirements and may impose fewer recordkeeping requirements.  By making FDA recalls mandatory, both the FDA and the industry benefit—if recalls were merely voluntary, in cases where a company refuses to cooperate, both players must engage in time-consuming, often bitter seizure actions.  
Overall, recall, whether mandatory or voluntary, gives both government and industry to avoid more adversarial consequences.  Cooperation in a recall is a factor in whether the FDA decides to publicize a violation or use a harsher enforcement measure.  Second, manufacturers will cooperate to develop a friendlier relationship with both the FDA and the public.  Also, with products being removed from the marketplace, recalls mitigate liability in products liability suits.  These considerations all set recall apart as a measure by which the industry can take on a greater sense of public responsibility.  No more is the government the sole protector of the public health.
In addressing federalism-related issues of statutory preemption, the Court has suggested one broad version of this “cooperation” counter-ideal.  In Buckman Co., the Court held that patients’ state law “fraud on the FDA” claims were impliedly preempted by the FDCA.  As a general policy matter, allowing such state-law would “inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.”  As for the industry, complying with the FDA’s detailed regulatory regime “in the shadow of 50 States’ tort regimes” would prohibitively burden would-be applicants from applying and innovating potentially beneficial off-label uses of drugs.  
The Court continued that applicants would throw all kinds of information, both relevant and irrelevant, at the FDA in order to avoid state lawsuits alleging that disclosures sufficient for the FDA were not so under state law.  Interminable delays would impede market competition as well as access to helpful off-label uses of drugs.  Overall, the Court in Buckman recognized that administrative streamlining was necessary not only for the integrity of the FDA, but also for the productivity of the industry and the consumption needs of the public.  
Similarly, in Abbott Laboratories, the Court emphasized “that [the industry] deal[s] in a sensitive industry, in which public confidence in their drug products is especially important.”  Accordingly, judicial review provides a buttress against the power of the government, such that the opportunities to challenge regulations are not limited to a company’s defense against an action brought by the government, especially when such limited opportunities more often than not will result in severe and unnecessary harm.  Although the issue of the appropriateness of judicial review of agency regulation looms over this entire idea of a cooperative venture between government and industry, the availability of Abbott Laboratories judicial review provides at least one bargaining chip for the industry.
As for perhaps the most contentious front between regulator and industry, namely tobacco products, the industry itself has recognized the need for a more cooperative mode of federal regulation.  Acknowledging one of the FDA’s grounds for jurisdiction over tobacco regulation, a Senior Vice President for Philip Morris Tobacco Company subsequently admitted that the industry needed to develop safer, less-addictive products:
I have a question about what’s the appropriate role of FDA…what I want to talk about is the right way to regulate the product…let’s work together to figure out the regulatory system, talking to members of Congress, that makes sense for tobacco products.  I understand the skepticism, I understand the hostility.  We have spent so much time pointing fingers at one another…that is over as far as I am concerned, for my part that is not going to happen.  What I want to do is figure out a policy that makes sense for the future….

	The Court’s framing of the regulatory world often has been too adversarial, and so may reinforce the FDA’s own attitude toward the industry and the need for a particular style of regulation.  Yet, ultimately, the fight will result with the most casualties incurred among the public, which needs protection from unsafe and ineffective drugs as well access to safe and effective ones.  Framing the regulatory world as a cooperative partnership sets the stage for a dialogue to better effect these goals; a head-to-head adversarial sensibility all too often stultifies the players from entering a dialogue in the first place.

VI. Conclusion
Overall, the reassessment and reform I suggest are indeed a “matter of sensibility.”  They go to the core of “our assumptions, imaginations of, and attitudes toward” the participants and prospects of FDA regulation of drugs, which always constitute a condition to understanding and evaluating legal norms in their status quo contexts.  
The conceptions of the relationship between government power and the public that we take from the Court’s jurisprudence in the area of FDA drug regulation are inadequate both to comprehending our present experience and to projecting images and ideals of a democratic society.  The task of theoretical reconstruction will draw upon various disciplines and a frank acknowledgement of the intensely political nature of administrative authority.  The effort to conceptualize FDA drug regulation as an experience of cooperative, inclusive decisionmaking and the consuming public as a well-informed locus of political activity may suggest general terms in which to conceive lawmaking and institution building as experiences of human self-development and purer democratic deliberation.  For these reasons, my altogether preliminary critique of the Court’s jurisprudence is motivated by the hope that comparative analyses of the internal realities of each of the players in the regulatory world (government, industry, and public) will clue each of these players, especially the government, into reformulating policy that is more responsive to these realities.