State leaders call on the FDA to follow medical evidence—not politics—on abortion pill access.
Attorneys general of four states—Massachusetts, California, New Jersey and New York—asked the U.S. Food and Drug Administration (FDA) on Thursday, June 5, to lift long-standing restrictions on the medication mifepristone. The drug is used in approximately two-thirds of abortions in the United States.
In a 54-page citizen petition, attorneys general Andrea Joy Campbell of Massachusetts, Rob Bonta of California, Matthew J. Platkin of New Jersey and Leticia James of New York argued the FDA’s mifepristone restrictions are medically unjustified, burdensome on patient access and place undue strain on the nation’s healthcare system.
The petition came just three days after the FDA commissioner Marty Makary announced his decision to “review” the agency’s regulation of mifepristone after previously stating he had no plans to restrict the medication. The decision was in response to a letter from Sen. Josh Hawley citing a flawed antiabortion report falsely claiming mifepristone is riskier than previously believed.
The FDA approved mifepristone in combination with a second mediation—misoprostol—for ending early pregnancies in 2000. Since then, the medication has been used safely by 7.5 million women. Over 100 peer-reviewed studies have shown mifepristone is safe—in fact safer than many medications without such restrictions, such as penicillin, Viagra and Tylenol.
“Given mifepristone’s 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,” said Attorney General James. “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.”
The petition targets three aspects of the FDA’s “risk evaluation and mitigation strategy” (REMS) for mifepristone:
- A prescriber certification requiring clinicians’ names to be added to national and local abortion provider lists, raising “serious safety and legal concerns,”
- Patient agreement forms, which require all patients using mifepristone to attest that they intend to end their pregnancies—even those being treated for miscarriage, and
- Pharmacy certification, which imposes complex tracking, shipping and reporting burdens.
The petition expressed concerns that these requirements are deterring clinicians from prescribing mifepristone and dissuading pharmacies from carrying the medication. The petition also cited evidence that emergency rooms are often cannot prescribe mifepristone for miscarriage due to certification hurdles.
The petitioners argued these requirements are “unnecessary, duplicative and burdensome” while not meaningfully improving patient safety, especially in their states that have robust regulations governing the practice of medicine.
The attorneys general urge the FDA to fully eliminate the mifepristone REMS program or, at a minimum, to stop applying the REMS requirements in New Jersey, California, Massachusetts and New York, where health care is highly regulated and abortion is safe and legal.
Federal law requires the FDA to respond to the petition within 180 days and provide documentation of the scientific support for its decision. The FDA may not change its regulation of mifepristone while the petition is pending.
FDA regulation of mifepristone is currently the subject of several lawsuits. A lawsuit in Texas, Missouri et al v. FDA, is attempting to further restrict mifepristone or remove it from the market. Meanwhile, a lawsuit filed in Virginia by the Center for Reproductive Rights, Whole Women’s Health Alliance v. FDA, is asking a federal district court to order the FDA to lift the REMS restrictions on mifepristone.
“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,” said Attorney General Bonta. “Its 25-year safety record is backed by science and cannot be erased at the whim of the Trump administration. We’re calling on the FDA to reverse course and maintain broad access to mifepristone.”
