Four Democrat-led states have petitioned the Food and Drug Administration to lift all restrictions on the abortion medication mifepristone amid reports that the agency is investigating the safety of the drug.
The attorneys general for California, Massachusetts, New Jersey, and New York filed the petition Thursday with the Department of Health and Human Services to make it easier for clinicians to prescribe and dispense mifepristone. It is part of a two-drug cocktail with misoprostol that has been the only FDA-approved method for medicated abortions through 12 weeks of pregnancy since 2000. Medicated abortions account for 54% of all abortions in the U.S., according to the Guttmacher Institute.
"Federal restrictions on mifepristone are burdensome impediments to reproductive choice and are not based in science or medicine," New Jersey Attorney General Matthew Platkin said Thursday in a statement. "The FDA has an opportunity to do the right thing and to eliminate barriers to access to this critical medication."
The petition asked the FDA to end the Mifeprex REMS Program. Mifepristone is the generic form of mifeprex; REMS stands for risk, evaluation, and mitigation safety. The REMS program requires a certification process for prescribers of mifepristone and pharmacies that carry it, in addition to a patient agreement form that affirms the patient intends to end her pregnancy.
The petition also asks the FDA not to enforce REM restrictions on the drug for prescribers practicing in their states because their states have sufficient protections to ensure patient safety.
"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 said in a statement. "New Yorkers, and all Americans, deserve access to this safe, effective, and essential medication without burdensome, unjustified restrictions. The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care."
FDA Commissioner Marty Makary reportedly wrote a letter Monday to Sen. Josh Hawley, R-Mo., in which he stated, "I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data." Hawley introduced legislation in the Senate last month to reinstate safety regulations on mifepristone that were relaxed by the Obama and Biden administrations.
In an April 28 letter to Makary, Hawley noted a recent study by the Ethics and Public Policy Center of 865,000 women prescribed mifepristone for abortions. The report found that nearly 11% who used mifepristone experienced sepsis, infection, hemorrhaging, an emergency room visit, or another serious adverse event within 45 days. It is at least 22 times greater than the less than 0.5% adverse event rate reported on the Biden administration's FDA-approved drug label for mifepristone.
But California Attorney General Rob Bonta said in a statement, "For decades, medication abortion has been recognized not only as effective, but so safe that it presents lower risks of serious complications than taking Tylenol or getting a colonoscopy."
Newsmax reached out to the FDA for comment.
Last year, the Supreme Court rejected a lawsuit seeking to roll back access to mifepristone. In a unanimous decision, the court ruled that the doctors and medical groups challenging the expansion of access to the drug by the FDA in 2016 and 2021 lacked standing.
Michael Katz ✉
Michael Katz is a Newsmax reporter with more than 30 years of experience reporting and editing on news, culture, and politics.
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