Is the FDA Sexist? Sex and the Drug Approval Process

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.