Document Type

Article

Publication Date

2023

Journal

Wisconsin Law Review

Volume

2023

Issue

4

First Page

1041

Last Page

1124

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.

DOI

https://doi.org/10.59015/wlr.OPFE2236

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