Four states filed a petition urging federal health officials to ease regulations regarding the use of mifepristone, a pill that is the most widely used method of abortion in the country.
Democratic attorneys general from California, Massachusetts, New York, and New Jersey filed the petition on Thursday. The states argued that mifepristone’s safety record and inclusion in the World Health Organization’s list of essential, lifesaving medicines justify its removal from the Food and Drug Administration’s category of drugs with known serious risks. The petition also attempted to combat concerns members of the Trump administration have voiced regarding the pill’s safety.
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“The medication is a lifeline for millions of women who need access to time-sensitive, critical healthcare — especially low-income women and those who live in rural and underserved areas,” California Attorney General Rob Bonta, a Democrat, said as he defended mifepristone against recent criticism from federal health officials, including from the FDA and Department of Health and Human Services.
“Given mifepristone’s 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,” New York Attorney General Letitia James, another Democrat, added. “The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.”
Mifepristone has been subject to the FDA Risk Evaluation and Mitigation Strategy, or REMS, program for years, meaning it must comply with certain regulations and enhanced scrutiny due to known “serious complications” the federal agency believes the pill poses.
Bonta called the FDA’s requirements “medically unjustified,” accusing them of hindering patient access and placing “undue strain on the nation’s entire health system.”
The petition from the four attorneys general marks a regulatory request for the FDA to reverse course nationwide, or else grant them the right to “exercise its discretion to not enforce the requirements” in their states.
The FDA has relaxed several regulations on the pill over the years, including extending the window in which mifepristone could be used to terminate pregnancies to 10 weeks and approving a generic form of the medication. Most recently, the FDA rolled back some of the REMS regulations in 2021 that required the pill to be dispensed only in person at a clinic, medical office, or hospital. The removal of the in-person dispensing requirement for mifepristone allowed for it to be prescribed via telehealth and provided for mail distribution through certified prescribers or pharmacies.
Several REMS regulations continue to regulate the abortion pill, including requirements that mifepristone be prescribed by a healthcare provider that meets certain qualifications and is certified under the REMS program, that the patient be provided with a copy of a patient agreement form and a mifepristone medication guide that provides FDA-approved information for patients, that the patient and healthcare provider review and sign the form, and that the risks of mifepristone be fully explained to women before mifepristone is prescribed.
Democrats believe the requirements are unnecessarily restrictive, discouraging women from obtaining abortions, with Bonta pointing to language in the patient agreement form that affirms women wish to end their pregnancy that the California Democrat said constituted a deterrent to women using the drug after a miscarriage. Democrats have also pointed to FDA data indicating risks of serious complications from mifepristone are rare.
Republicans, including Sen. Josh Hawley (R-MO), have showcased recent studies they say prove complications are possibly 22 times higher than data used by the FDA, pointing to insurance claims data from over 865,000 mifepristone prescriptions that concluded nearly 11% of women experience a possibly life-threatening complication within 45 days of a mifepristone abortion.
On Monday, FDA Administrator Marty Makary committed to conducting a federal review of mifepristone and “working with professional career scientists at the agency who review this data.” His pledge came after HHS Secretary Robert F. Kennedy Jr. said during a Senate hearing last month that he had ordered Makary to conduct a “complete review” of mifepristone and its labeling requirements.