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Axios – Thursday, September 25, 2025
By Peter Sullivan
The Food and Drug Administration said it will conduct a “study” of the safety protocol around the widely used abortion drug mifepristone, in a move that could lead to new dispensing restrictions.
Why it matters: New rules around the drug, especially those addressing its widespread availability through telehealth, could severely limit access in states with abortion bans.
What they’re saying: “Through the FDA, HHS will conduct a study of the safety of the current [safety protocol], in order to determine whether modifications are necessary,” Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary wrote in a letter dated Sept. 19 to Republican attorneys general.
The state officials had pressed the administration to put new safety limits on the pills.
One of the most consequential potential changes is reviving a requirement that the drug be dispensed in person. That would effectively cut off teleprescribing and mailing of the abortion drugs, which now account for more than 60% of all abortions in the health system.
Between the lines: FDA had pledged a “review” of the safety data around mifepristone in June, but the language of this letter appears to go farther in raising doubts about the drug.
Still, it is unclear what, if any, limits will actually be announced. Any such moves would be extremely controversial and call into question President Trump’s campaign pledge to leave abortion policy to the states.
“This administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” the letter states.
The other side: Pro-abortion rights groups say the drug, which the FDA originally approved in 2000, has repeatedly been found in studies to be safe — and that the latest concerns are being raised as a guise by anti-abortion advocates to limit access.
“Mifepristone is safe, effective, and essential,” said Mini Timmaraju, president of Reproductive Freedom for All, in response to news of the study. “This is political interference designed to rip away our freedoms.”
