The states consider it a move to force the F.D.A. to review and acknowledge extensive research showing the pill’s safety.
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.
“The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care,” Letitia James, the attorney general of New York, said after the petition was filed on Thursday.
The F.D.A. is required to respond to the petition 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.
“We’re glad the F.D.A. will re-examine the data after the Biden administration fueled an unregulated drug market, stripping the crucial safeguard of in-person dispensing for these high-risk drugs.” Katie Glenn Daniel, director of legal affairs for the anti-abortion group SBA Pro-Life America, said on Thursday.
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.”
Recently, a conservative faith-based organization released a report saying that mifepristone is more dangerous than the vast majority of studies show. Some conservative Republicans have urged Mr. Kennedy and the F.D.A. commissioner, Dr. Marty Makary, to review the drug based on that report.
Medical experts in reproductive health point to flaws in the report, including that it was not peer-reviewed and doesn’t disclose the source of the insurance claims data it analyzed. The report also uses atypical methods to characterize what it calls “serious adverse events,” making it unclear, for example, whether an emergency room visit involved complications from mifepristone or other, more common issues that were either not serious or were unrelated to abortion, reproductive health experts say.
Asked about the report at a recent hearing, Dr. Makary said “there is no peer-reviewed publication, and the underlying data set is not available, but when it does become available, we’re going to take a hard look at it.” In a written response to Senator Hawley, Dr. Makary said he was “committed to conducting a review of mifepristone and working with the professional career scientists at the agency who review this data.”
The petition requests that if the F.D.A. declines to lift the REMS, it “exercise its discretion not to enforce” some or all of those restrictions in the four states because their regulations are sufficient.
The REMS provisions still in place include special certification processes for prescribers and for pharmacies dispensing mifepristone, requirements the petition says are unnecessary and have discouraged some providers from offering the medication.
Another requirement is an agreement patients must sign saying they are taking mifepristone because they decided to terminate their pregnancy. But mifepristone is also used to help with miscarriages, and, the petition notes, miscarriage patients must sign the same form.
For years, leading medical organizations have called for removing REMS restrictions on mifepristone, and several lawsuits seeking REMS removal are pending against the F.D.A., including one by attorneys general of 12 other states.
