Is the FDA Sexist? Sex and the Drug Approval Process

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Is the FDA Sexist? Sex and the Drug Approval Process

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Petrovic, Emily S. en_US
dc.date.accessioned 2012-06-07T04:54:25Z
dc.date.issued 2003 en_US
dc.identifier.citation Is the FDA Sexist? Sex and the Drug Approval Process (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8846799
dc.description.abstract This paper examines the role of sex in the drug approval process. Medical literature has explored in great depth the many ways in which men and women differ, sometimes dramatically, often in ways that are seemingly unrelated to the physical, anatomical distinctions between the two sexes. After years of intentionally excluding women from critical phases of clinical drug trials, the FDA formally reversed such policies in the 1990s. A number of prescription drugs recently removed from the market disproportionately harmed women as compared to men. Loopholes in the current system have perpetuated the drug approval process’s inadequate consideration for the needs of women, thereby subjecting them to a higher level of risk. Efforts to correct for the lack of drug trials aimed to ensure the safety and efficacy for pediatric patients are also reviewed to provide a contrast. While the intentional biases in the system have been addressed, the current drug approval process fails to provide women with the same degree of protection as it does men. A number of issues remain requiring additional study and consideration before a complete solution can be proposed. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject drug approval process en
dc.subject sex differences en
dc.subject prescription drugs en
dc.subject FDA en
dc.title Is the FDA Sexist? Sex and the Drug Approval Process en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T04:54:25Z

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