Hutt, Peter BartonGoldstein, Lori M.2012-07-062001DRUG THERAPY AND PREGNANCY: UNKNOWN RISKS LEAD TO HARD CHOICES [REDACTED VERSION] (2001 Third Year Paper)http://nrs.harvard.edu/urn-3:HUL.InstRepos:8965596This paper is a proposal to improve the quality of information available to pregnant patients in selecting treatment options. By providing drug companies with extended grants of exclusivity, the FDA has the ability to empower pregnant women to take control of their health and make informed decisions. Granted post-marketing surveillance will always catch ADRs at a later stage of the game than pre-market clinical trials, but in the case of pregnant women; where we must concern ourselves with potential harms to a future sentient child - increased rigor in the method and quantity of post marketing surveillance techniques seems like the only way to go.en-USFood and Drug LawFDApregnancydrug testingPaper (for course/seminar/workshop)2012-07-06