HHS says FDA is reviewing mifepristone safety after Sept. 19 letter
In a Sept. 19 joint letter, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary said the FDA will review mifepristone’s safety, its REMS and “real‑world outcomes,” citing FDA data from 2000–2012 that recorded 2,740 adverse events including 416 transfusions and referencing an EPPC study that reported nearly 11% serious adverse events within 45 days. The letter names policy options such as reinstating an in‑person dispensing requirement that would end telehealth prescribing and mailing of the pill into states with abortion bans, prompting alarm from abortion‑rights groups and clinicians who point to numerous studies and expert analyses finding mifepristone to be highly safe (with some estimates of serious complications well under 1 in 200).
📰 Sources (3)
- Identifies the Sept. 19, 2025 letter from HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary as the triggering document for the review.
- Quotes the letter language saying the FDA is reviewing 'real‑world outcomes and evidence' and the drug’s REMS.
- Cites FDA data (2000–2012) referenced in the letter: 2,740 adverse events, including 416 events involving blood loss requiring transfusions.
- Notes the EPPC study cited by Kennedy claims nearly 11% serious adverse events within 45 days, while CBS quoted Dr. Celine Gounder saying other data show serious complications are much lower (~<1 in 200).
- Records reactions: ACLU statement noting 'more than 100 studies confirm mifepristone's exceptional safety record,' and contextual facts (approved in 2000; used by >7.5 million women; approved through 10 weeks).
- A joint letter from HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary dated Sept. 19 was sent to state attorneys general announcing a study of the current safety protocol for mifepristone.
- One policy option explicitly cited is reinstating an in‑person dispensing requirement that would end telehealth prescribing and mailing of the pill into states with abortion bans.
- Direct quotes from health‑policy and advocacy figures reacting to the move (KFF, Susan B. Anthony Pro‑Life America, Sen. Josh Hawley, Reproductive Freedom for All) are provided, showing political alignment and anticipated reactions.
- Health Secretary Robert F. Kennedy Jr. initiated an FDA review of mifepristone (the medication abortion pill).
- Mifepristone is used in roughly two‑thirds of abortions in the United States, according to the CBS News report.
- Abortion‑rights groups express concern the review could prompt federal restrictions that would affect access even in states where abortion is currently legal.