Four States Ask F.D.A. to Lift Special Restrictions on Abortion Pill
The states consider it a move to force the F.D.A. to review and acknowledge extensive research showing the pill’s safety. Mifepristone, which blocks a hormone necessary for pregnancy to develop, was approved for abortion in the U.S. in 2000.
In a strategy aimed at countering efforts to further restrict the abortion pill mifepristone, attorneys general of four states that support abortion rights on Thursday asked the Food and Drug Administration to do the opposite and lift the most stringent remaining restrictions on the pill.
The petition filed by Massachusetts, New York, California and New Jersey might seem surprising given the opposition to abortion expressed by Trump administration officials. But the attorneys general consider it a move that would require the F.D.A. to acknowledge extensive scientific research that has consistently found mifepristone safe and effective, said an official with the Massachusetts attorney general’s office who worked on the filing and asked not to be named in order to share background information. It would also prevent the F.D.A. from changing mifepristone regulations while the petition is pending.
The petition notes that at a May senate hearing, Robert F. Kennedy Jr., the health and human services secretary, responded to questions by Senator Josh Hawley, Republican of Missouri, who opposes abortion, by saying he had ordered the F.D.A. to do a “complete review” of mifepristone.
“We want to make sure that when F.D.A. is making these decisions that they have all the data in front of them, all of the really powerful data that show that mifepristone is safe” the Massachusetts official said.
The F.D.A. is required to respond within 180 days by granting or denying the request, or saying it needs more time. In its responses, the agency must document its position, which could be useful in lawsuits, including one that the four states could file if their petition is denied.
Mifepristone, which blocks a hormone necessary for pregnancy development, was approved for abortion in America in 2000. The F.D.A. imposed an additional regulatory framework called Risk Evaluation and Mitigation Strategy, or REMS, on mifepristone. That framework has been used for only about 300 drugs, currently covering only about 60 medications.
Mifepristone is the first pill in the two-drug medication abortion regimen in the United States, used through 12 weeks of pregnancy. It is followed 24 to 48 hours later by misoprostol, which causes contractions like a miscarriage. Misoprostol can terminate pregnancies itself but hasn’t generally been targeted by abortion opponents, perhaps because it isn’t specifically approved for abortion and can treat several medical conditions, including ulcers.
In the last decade, the F.D.A. reviewed new data on mifepristone and lifted several restrictions, including a requirement that patients obtain it in person from a provider. That change, in 2021, allowed it to be prescribed by telemedicine and mailed to patients, expanding access to mifepristone, now used in nearly two-thirds of American abortions.
The states’ filing, called a citizen petition, seeks a complete lifting of the REMS framework, saying that “given mifepristone’s well-established, 25-year safety record, F.D.A.’s current restrictions on mifepristone are no longer justified by science or law.” Citing new studies, it says “mifepristone’s safety has remained stable even as its restrictions have been lessened” and that continuing the restrictions “cannot be squared with the F.D.A.’s lack of REMS programs on drugs that have significantly more risks than mifepristone.”
