A Critical Analysis of the FDA’s 2021 Mifepristone REMS Modification Rationale Review

Abstract

Mifepristone was first approved in 2000 in conjunction with misoprostol to induce abortion, and both its initial approval and subsequent regulation have been controversial. In 2021, the Food and Drug Administration (FDA) undertook a full review of the mifepristone Risk Evaluation and Mitigation Strategy (REMS) program, with the aim of assessing the necessity of each of the three Elements to Assure Safe Use (ETASUs) present in the mifepristone REMS, including ETASU C, the “in-person dispensing requirement.” Following this review, the FDA concluded that ETASU C could be safely removed and that mifepristone could be safely dispensed outside of the previously approved settings. This paper seeks to critically analyze the 2021 REMS Review, as well as the studies cited therein to determine whether the evidence presented by the FDA sufficiently substantiated this decision. Factors that render the cited studies non-replicative of real-world, non-study conditions and therefore unable to be generalized to these contexts are highlighted. Differential treatment of stakeholder input and limitations of abortion complication reporting systems are also discussed. The clinical implications of the FDA’s decision to remove ETASU C are noted, followed by several actionable recommendations to the FDA.

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