It was only about a year ago that the biopharma industry hailed a decision by the Supreme Court to preserve access to mifepristone, a drug most commonly known for its paired use with another medicine to terminate early pregnancies and medically manage miscarriages. But after being pushed by attorneys general from 22 states, U.S. healthcare leaders are taking another look at the circumstances under which the drug can be prescribed.
In a Sept. 19 letter (PDF) made public this week, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., pledged to review mifepristone's Risk Evaluation and Mitigation Strategies (REMS), a drug-specific prescribing protocol required by the FDA that is designed to ensure safe use.
Mifepristone won FDA approval in 2000 as a medication abortion and had its REMS program "relaxed" in 2016, Kennedy and Makary wrote in their letter. Also in 2016, the FDA moved to increase the mifepristone access and usage window from seven weeks of gestation to 10 weeks.
More recently, in 2021, during the COVID-19 pandemic, the FDA decided to remove the in-person dispensing requirement for mifepristone, with the official change taking place in early 2023, according to an agency Q&A. The decision was made after a "comprehensive review" of the REMS program and was meant to reduce burden on the healthcare delivery system and "ensure the benefits of the product outweigh the risks."
The change meant that mifepristone could be prescribed via telehealth platforms and shipped by mail, significantly expanding access to the drug and its use in the post-Dobbs era.
Come July of this year, a group of 22 state attorneys general wrote a letter (PDF) to Kennedy and Makary to voice concerns with the current REMS setup. They cited an April 2025 review of insurance claims data to argue that the rate of serious adverse events associated with mifepristone is significantly higher than indicated on the drug's prescribing label, urging the FDA to impose a stricter REMS program on the medication or take it off the market until health officials can complete a review.
The insurance claim review was conducted by the Ethics and Public Policy Center, an anti-abortion conservative think tank that has not provided the dataset behind its claims—the source of the data was not disclosed, and the work was not peer-reviewed.
Now, Kennedy and Makary are pledging to evaluate the safety program.
"HHS is committed to studying the adverse consequences reported in relation to mifepristone to ensure the REMS are sufficient to protect women from unstated risks," Kennedy and Makary wrote to the AGs. "Therefore, through the FDA, HHS will conduct a study of the safety of the current REMS, in order to determine whether modifications are necessary."
The federal healthcare leaders took issue with a "lack of adequate consideration underlying" the FDA's prior REMS changes and said they want to examine "recent studies raising concerns about the safety of mifepristone as currently administered."
The primary safety report at issue comes from EPPC, whose work has ignited another wave of scrutiny around mifepristone after the drug overcame a high-profile legal challenge in recent years. Notably, a lawsuit from the Alliance for Hippocratic Medicine made it all the way to the Supreme Court, which preserved access to the drug with its unanimous ruling in June 2024.
In the SCOTUS decision, the justices didn't rule on whether the FDA acted properly in relaxing mifepristone's REMS programs, according to SCOTUSblog. Instead, the High Court simply said the plaintiffs didn't have legal grounds to bring the case.
Nevertheless, the biopharma industry hailed the decision as a win for the FDA's independence from outside pressure.
That pressure has not ceased, though, with legal challenges and now the renewed FDA review continuing on. Besides the FDA's REMS review, several Republican-led states are trying to work through the courts to halt telemedicine access to the drug for abortions, Bloomberg reports.
Conversely, several pro-choice states are urging the FDA to eliminate remaining REMS stipulations on mifepristone. In their petition, the AGs from pro-choice states noted that the FDA itself said in 2016 that "[medical abortion] has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare."
Mifepristone is a progesterone blocker approved as Mifeprex in conjunction with Cytotec (misoprostol) for early pregnancy loss and termination. The drug is also sold as Korlym to treat certain patients with Cushing's syndrome, a common hormonal disorder.