Document Type

Article

Publication Date

2022

Abstract

Restrictive state abortion laws garner a large amount of attention in the national conversation and legal scholarship, but less known is a federal abortion policy that significantly curtails access to early abortion in all fifty states. The policy limits the distribution of mifepristone, the only drug approved to terminate a pregnancy so long as it is within the first ten weeks. Unlike most drugs, which can be prescribed by licensed healthcare providers and picked up at most pharmacies, the Food and Drug Administration only allows certified providers to prescribe mifepristone, and only allows those providers to distribute the drug to patients directly, in person, not through pharmacies. This policy segregates abortion care outside of the traditional healthcare setting and into abortion clinics, which provide ninety-five percent of abortions. As a result, women must often travel long distances to simply pick up a prescription at a clinic—an obstacle that disproportionately harms low-income women, women of color, and rural women. This paper is the first to examine the burdens, benefits, and impact of the mifepristone REMS. It argues that mifepristone fails to meet the statutory criteria for a REMS, and that the FDA’s improper regulation of mifepristone is a part of a larger history of the agency discounting women’s health. It concludes by exploring the future of early abortion care without the mifepristone REMS—a reality that may soon come to pass under the Biden administration. Without the REMS, women would be able to terminate an early pregnancy entirely through telemedicine, avoiding the logistical hurdles, lack of privacy, and harassment that occurs at clinics. These benefits will continue for women living in liberal states even if Roe v. Wade is limited or overturned, accelerating the disparity in abortion access across state lines and the trend toward self-managed abortion in states that have restricted abortion.

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