FDA to “review the latest data” on mifepristone. What could it mean for access to the abortion pill?

Health and Human Services Secretary Robert F. Kennedy Jr. has requested Food and Drug Administration Commissioner Marty Makary to conduct a review of mifepristone, commonly known as the abortion pill. The FDA confirmed this plan, although details about the timing and scope of the review have not been disclosed.

Mifepristone, in combination with misoprostol, is used for medical abortion and was approved by the FDA in 2000 after a thorough evaluation of its safety and effectiveness. Subsequent reviews have not raised new safety concerns. However, a report from the Ethics and Public Policy Center, funded by right-wing organizations, has raised questions about the drug’s safety, claiming that it causes serious adverse events in 1 out of 10 patients.

Dr. Céline Gounder, a medical contributor at CBS News, has expressed skepticism about the report’s findings, noting that some of the events described as adverse may be normal side effects of the medication. She also highlighted the lack of transparency and comparison groups in the report, making it difficult to verify the claims.

The Supreme Court previously rejected a challenge to mifepristone’s availability in 2024, preserving access to the drug. Despite ongoing scrutiny from abortion opponents, the FDA has stated that there are no immediate plans to take action on mifepristone.

Since its approval, mifepristone has been used by over 5 million patients, with medication abortions accounting for a significant portion of all abortions in the US healthcare system. However, policies in 28 states restrict access to mifepristone in various ways, including limitations on mailing abortion pills to patients.

As the review of mifepristone continues, the impact on access to the drug remains uncertain. Stay tuned for updates on this developing story.

Contributors to this report include Melissa Quinn and Alexander Tin.

Sara Moniuszko is a health and lifestyle reporter at CBSNews.com, covering breaking and trending news for CBS News’ HealthWatch. With previous experience at USA Today, she brings a wealth of knowledge to her reporting on health and wellness topics.