FDA starts safety study of abortion pill mifepristone

Summary

FDA began a large safety study of mifepristone, with interim results that could be released in July.

Why this matters

Mifepristone is widely used in medication abortions, and the FDA review could shape future access, including rules for telehealth, mail delivery, and prescribing. The study also comes amid ongoing court fights over the drug's availability.

The Food and Drug Administration has begun a safety study of the abortion pill mifepristone, a senior FDA official confirmed to CBS News.

The study will review hundreds of thousands of past cases, the official said. Interim results could be released in July, though the timing of final results will depend on the design of a secondary analysis after those findings are reviewed.

In a letter last September to several Republican state attorneys general, Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA was reviewing mifepristone’s safety.

At the time, Kennedy and then-FDA Commissioner Martin Makary wrote, “HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”

The renewed review followed a Biden administration memorandum that lifted restrictions requiring mifepristone to be dispensed in person and expanded access through telehealth and mail delivery.

Last year, Louisiana sued over the FDA’s decision to allow mifepristone to be delivered by mail.

On May 4, the U.S. Court of Appeals for the 5th Circuit temporarily reinstated the in-person dispensing requirement. The next week, the Supreme Court set aside that order, allowing mifepristone to continue to be mailed to patients while the Louisiana case proceeds.

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