A Critical Analysis of the FDA’s 2021 Mifepristone REMS Modification Rationale Review
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.
Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019
Online Article Coming Soon. Click here to download Article PDF