Citing 25 Years of Proven Safety, Four AGs Petition FDA to End Unnecessary Restrictions on Mifepristone
New York Attorney General Letitia James and the attorneys general of California, Massachusetts, and New Jersey today filed a petition asking the U.S. Food and Drug Administration (FDA) to eliminate unnecessary and outdated restrictions on the abortion medication mifepristone. Attorney General James and the coalition argue that mifepristone has proven overwhelmingly safe and effective in the 25 years since it was first approved by the FDA, and that the agency’s current Risk Evaluation and Mitigation Strategy (REMS) program imposes burdensome restrictions on access to medication abortion while not meaningfully improving patient safety. The petition comes as the FDA undertakes a full review of mifepristone labeling requirements at the direction of Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr. The U.S. Code of Federal Regulations grants individuals and organizations the ability to petition the FDA to issue, change, or cancel a regulation, or to take other action. Attorney General James and the coalition are urging the FDA to use this full review of mifepristone to lift unjustified restrictions and maximize access to this essential medication.
“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.”
Mifepristone, used in combination with misoprostol, is the most common method for ending early pregnancy in the United States and is also the standard of care for managing early miscarriage. Since it was first approved by the FDA in 2000, more than 7.5 million people in the U.S. have used mifepristone. According to leading medical organizations, as well as the FDA itself, serious complications are “extremely rare,” and no deaths have ever been definitively attributed to the drug. Mifepristone is even on the World Health Organization’s core list of essential, life-saving medicines.
Despite this safety record, mifepristone remains subject to a REMS program designed for drugs with known, serious risks, which involves three burdensome requirements:
- Prescriber certification, which deters clinicians from prescribing the medication by requiring their names to be added to national and local abortion provider lists, raising serious safety and legal concerns;
- Patient agreement forms, which all patients must sign – even those being treated for miscarriage – attesting they intend to “end [their] pregnancy”; and
- Pharmacy certification, which imposes complex tracking, shipping, and reporting burdens that dissuade pharmacies from carrying mifepristone.
Attorney General James and the coalition argue these REMS requirements are medically unnecessary and significantly impede access to care, especially in rural and underserved communities. The attorneys general assert that the vast administrative burden associated with REMS requirements has kept mifepristone out of most family medicine practices and primary care settings, despite its low risk and ease of use. Many primary care and family medicine physicians report viewing the complex process as not worth the effort. As a result, medication abortion is largely limited to specialized settings, with only one percent of such abortions occurring at primary care facilities. Meanwhile, nearly 90 percent of U.S. counties lack a single abortion provider.
The attorneys general emphasize that these restrictions stand in stark contrast to the FDA’s treatment of far riskier medications. Drugs like opioids, blood thinners, and even other formulations of mifepristone used to treat illnesses like Cushing’s syndrome are not subject to such restrictive REMS programs. FDA-approved drugs for cosmetic procedures and erectile dysfunction, despite well-known risks for serious complications, also face fewer barriers than mifepristone.
Attorney General James and the coalition also cite mounting evidence that the REMS program burdens the entire health care system. Emergency rooms often cannot prescribe mifepristone due to certification hurdles, despite it being critical for patients experiencing miscarriages. Pharmacies also struggle to meet the administrative burdens of certification requirements, and some have even faced coordinated pressure campaigns and threats simply for attempting to stock the medication. When Walgreens announced plans to seek certification, it was met with intimidation and threats and ultimately declined to dispense the drug in 20 states, including several where abortion remains legal. Following this announcement, Attorney General James sent a letter to Walgreens and other pharmacies, urging them to confirm mifepristone would remain available in New York.
In the petition, the attorneys general refute recent attempts to challenge mifepristone’s safety using methodologically flawed scientific research papers, noting that several of these papers have been retracted by medical journals. The FDA itself has acknowledged that mifepristone’s safety has remained stable, even after prior REMS restrictions, such as in-person dispensing requirements, were lifted.
Under federal law, REMS requirements must mitigate a specific serious risk and cannot be “unduly burdensome” on patients or health care delivery systems. Attorney General James and the coalition argue that the current mifepristone REMS fails to meet that standard. They point to robust state laws already in place in New York and other states that ensure safe prescribing, rigorous informed consent, and professional accountability. The FDA is also specifically directed to account for access in rural areas and to minimize unnecessary burdens on the health care system, criteria that the mifepristone REMS does not meet.
Given mifepristone’s strong safety record and essential role in abortion and miscarriage care, Attorney General James and the coalition assert that the current REMS program is both scientifically and legally indefensible. The attorneys general are asking FDA to fully eliminate the mifepristone REMS program, including prescriber, pharmacy, and patient certification requirements; or, at minimum, exercise enforcement discretion and cease applying REMS elements in New York, California, Massachusetts, and New Jersey, states where abortion is legal and safe, and health care is highly regulated.
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