Abstract
American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, abortion pills would still be prescription medicines—a status that, in and of itself, hinders people’s access to drugs. This Article thus advocates going further by repealing the prescription requirement for abortion pills. To support this proposal, the Article analyzes the prescription-to-OTC switch process for drugs generally, explores how prescription status impedes access, and argues that FDA should give greater weight to the benefits of improved access when considering any OTC switch. The Article discusses recent promising instances of successful switches—including naloxone and birth control pills— in which FDA emphasized the access factor more than it traditionally has. Finally, the Article considers various intermediate approaches between prescription and OTC status and explains how federal and state regulators might use these approaches to improve access to abortion pills in the absence of a complete switch.
Publisher
University of Wisconsin Law School
Subject
General Medicine,General Earth and Planetary Sciences,General Environmental Science,Pharmacology (medical),Complementary and alternative medicine,Pharmaceutical Science,Religious studies,History,Cultural Studies,Materials Chemistry,Economics and Econometrics,Media Technology,Forestry,Industrial and Manufacturing Engineering,Metals and Alloys,Strategy and Management,Mechanical Engineering,General Engineering,General Medicine,General Engineering,General Engineering