Study finds FDA mifepristone decisions largely followed scientific advice

A study led by experts at Johns Hopkins and published in JAMA found that the Food and Drug Administration’s decisions about the abortion pill mifepristone from 2011 to 2023 almost always followed evidence-based recommendations from the agency’s scientists. The researchers obtained 264 documents totaling 5,239 pages through Freedom of Information Act requests and a lawsuit, including internal memos, emails, agency reviews and company reports.

They reported that the agency repeatedly evaluated new evidence and reaffirmed that mifepristone is safe, citing adverse event reports, clinical studies, manufacturer assessments and published literature. One internal review noted that among 1.88 million women who had used mifepristone as of Oct.

31, 2012 there were 2,740 adverse events, about one in 2,448 required hospitalization, and 14 deaths with at least three described as unrelated to the drug. The study identified a major exception during 2020, when F.D.A. scientists supported lifting an in-person dispensing requirement during the Covid pandemic but agency leaders declined to do so; the in-person requirement was removed in spring 2021.

The researchers also described other cautious expansions, including 2016 changes that allowed more types of providers to prescribe, extended the gestational limit to 10 weeks and removed the requirement that misoprostol be taken in the presence of a doctor.

Key Topics

Health, Mifepristone, Fda, Johns Hopkins, Jama, Rems