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FDA Says It Won’t Act On Abortion Drugs Till March, 2 Years After Pledging To Review Safety Concerns

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08.10.2026

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FDA Says It Won’t Act On Abortion Drugs Till March, 2 Years After Pledging To Review Safety Concerns

The final review is expected more than two years after RFK Jr. and the former FDA commissioner pledged to ‘study the safety’ of abortion pills.

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The U.S. Food and Drug Administration plans to finalize its long-awaited safety review of the most prolific abortion pills on the market, but it won’t do so until March 2027, according to a court document filed on Wednesday.

The expected completion date comes more than two years after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary pledged to “study the safety” of abortion pills and approximately three months after the FDA anticipates a wrap on its mifepristone study. According to the five-page filing, the FDA is “using a variety of data sources contained within Sentinel, a distributed database, to conduct the study.”

No review is required for the regulatory agency to reinstate some of the abortion pill safeguards, including an in-person doctor visit, that were stripped at President Joe Biden’s behest. The FDA confirmed, however, that it will not consider amending the Risk Evaluation and Mitigation Strategy that currently allows anyone to order mifepristone to any state regardless of its abortion laws until after the “completion of its study and review.”

By my estimation, 18,000 women will face serious adverse events related to mifepristone abortions during the 3 months between when @FDA has its mifepristone safety study results in mid-December and when it publishes its final report in March. https://t.co/vY8NxehwoI— Jamie Bryan Hall (@Mr_Jamie_B_Hall) October 8, 2026

By my estimation, 18,000 women will face serious adverse events related to mifepristone abortions during the 3 months between when @FDA has its mifepristone safety study results in mid-December and when it publishes its final report in March. https://t.co/vY8NxehwoI

This REMS evaluation, the agency claimed, will consider “arguments and information submitted to the Agency in multiple pending Citizen Petitions” and could affect the projected March 2027 “estimated date of completion.”

The long-awaited mifepristone status update was announced the same day a court-ordered deadline for the FDA to share its review plans was set to expire.

In his Apr. 7 opinion in the landmark abortion pill lawsuit Louisiana v. FDA, U.S.........

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