Though state laws dominate the abortion debate, there is a federal abortion policy that significantly curtails access to early abortion in all fifty states. The policy, known as a Risk Evaluation and Mitigation Strategy (REMS), 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 until December 2021, only allowed those providers to distribute the drug to patients directly, in person, not through pharmacies. This policy has segregated abortion care outside of the traditional healthcare setting and into abortion clinics, which provide ninety-five percent of abortions. This paper is the first to examine the burdens, benefits, and impacts 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 biased decision-making over sexual and reproductive health. It concludes by exploring impending modifications to the mifepristone REMS, what they mean for the future of early abortion care, and how the FDA can go further to remove unnecessary barriers to medication abortion.
To read this Article, please click here: Medication Abortion Exceptionalism.