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Keywords: FDA

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.

United Kingdom Data Deficiencies Influencing U.S. FDA Decisions

UK-Data

Ingrid Skop, M.D., et al., in this article, discusses the implications of the U.S. FDA permanently removing the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this article.

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