Four states petition the FDA to lift abortion pill restrictions

NBC News

a day ago

Four states petitioned the Food and Drug Administration on Thursday to lift its lingering restrictions on abortion pills.
The attorneys general of California, Massachusetts, New Jersey and New York argue in the petition that the FDA's current regulations make it difficult to prescribe mifepristone — one of two pills involved in a medication abortion — in primary care settings, despite evidence that it's safe to do so.
'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. 'The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.'
The drug is a central flash point in the abortion debate. Many anti-abortion groups see restricting who can get mifepristone or rescinding its approval as one of the most effective ways to limit abortion access nationwide.
The petition comes just days after FDA Commissioner Marty Makary said he was committed to conducting a safety review of mifepristone.
Health and Human Services Secretary Robert F. Kennedy Jr. and Sen. Josh Hawley, R-Mo., each requested the review following the release of a paper, which was neither peer-reviewed nor published in a medical journal, that claimed to find a high rate of serious adverse events in women who recently took the medication. Researchers who study reproductive health said the report amounts to junk science and exaggerates the risks of mifepristone. They note that it does not meet basic research standards, relying on overly broad definitions and failing to disclose which database it used.
The report was released by the Ethics and Public Policy Center, a conservative think tank that served on the advisory board of Project 2025, a right-wing policy initiative that called for the FDA to walk back its approval of mifepristone.
The attorneys general said Thursday that the FDA should use the safety review as an opportunity to remove barriers to accessing mifepristone nationwide — or, at minimum, in the four states involved in the petition.
The FDA regulates certain medications with serious safety concerns via a drug safety program called Risk Evaluation and Mitigation Strategies (REMS). Mifepristone is currently part of that program, though a wealth of research has shown that less than 0.5% of women who take it have serious adverse reactions. Studies have also demonstrated that prescribing mifepristone through telehealth is as safe and effective as administering it in person.
As part of the REMS program, mifepristone is subject to a few restrictions: People who prescribe the pills must be certified health care providers, and pharmacies must obtain certifications to dispense the medication. Patients who receive mifepristone must also sign a form attesting that they intend to end their pregnancy.
The attorneys general said in their petition that those restrictions are burdensome and unnecessary. They claim that many primary care and family medicine physicians aren't able or willing to take on the administrative burden of getting certified to prescribe the pills, or are worried about being added to a list of national or local abortion providers.
The FDA has already lifted several restrictions on mifepristone over the last decade. In 2016, it extended the window in which mifepristone could be used to terminate pregnancies from seven weeks' gestation to 10 weeks. In 2019, it approved a generic form of the medication, which increased supply. And in 2021, it eliminated a requirement to dispense mifepristone in person, allowing the drug to be prescribed via telehealth and sent by mail.
Anti-abortion groups have called on the FDA to reinstate those restrictions, often pointing to misleading studies that suggest the medication has harmful effects. The April report that launched the FDA safety review, for instance, claims to find a 22-times higher rate of serious complications from mifepristone than reported by the agency.
In their petition Thursday, the four attorneys general denounced recent attempts to challenge mifepristone's safety, which they said rely on methodologically flawed research.
A coalition of anti-abortion groups sued the FDA in 2022 over its approval of mifepristone, citing two studies from the Charlotte Lozier Institute, a group that opposes abortion, that claimed to show severe complications from the drug. The lawsuit was ultimately thrown out by the Supreme Court and the studies were later retracted by a medical publisher.
The Charlotte Lozier Institute released another paper last month claiming that a growing number of emergency room visits after abortions are incorrectly attributed to miscarriages, thereby masking abortion complications.
Rachel Jones, a principal research scientist at the Guttmacher Institute, a research organization that supports abortion access, said the data only captures a small portion of abortions and is skewed in favor of those that are potentially higher risk. Some of the same data was used in the retracted studies, she said.
Jones added that the timing of the new reports from anti-abortion groups is not coincidental.
'The anti-choice people are really going after medication abortion and doing whatever they can to get the FDA under the Trump administration to revisit the availability of the drug,' she said.