Press Release: 6/6/2025

AG Campbell Files a Citizen Petition with the FDA to Remove Unnecessary Restrictions on Mifepristone

 

FOR IMMEDIATE RELEASE:

6/05/2025

MEDIA CONTACT

Kennedy Sims, Deputy Press Secretary

 Phone

Call Kennedy Sims, Deputy Press Secretary at (617) 727-2543

 Online

Email Kennedy Sims, Deputy Press Secretary at Kennedy.Sims@mass.gov

BOSTON — Massachusetts Attorney General Andrea Joy Campbell, alongside state attorneys general from California, New York, and New Jersey, filed a Citizen Petitionurging the U.S. Food and Drug Administration (FDA) to eliminate unnecessary restrictions on mifepristone, the widely used medication in the two-drug regimen for early-term abortions. In their petition, AG Campbell and the coalition argue that the current Risk Evaluation and Mitigation Strategy (REMS) program imposes burdensome restrictions on access to medication abortion while not meaningfully improving patient safety, and that these restrictions severely impede patient access by reducing the number of prescribers and pharmacies authorized to dispense this FDA-approved medication. The petition argues that these restrictions are particularly unnecessary in states like Massachusetts which have robust regulations governing the practice of medicine. The petition is also timed to respond to a recent directive from Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. to FDA Administrator Martin Makary to conduct a “complete review” of mifepristone and its labeling requirements. 

In most petitioning states where abortion is still legal and protected by state laws, medication abortion via a regimen of mifepristone and misoprostol is the primary method of abortion care. In fact, for the past 25 years, the mifepristone-misoprostol regimen has been the most common method for early-term abortion care in the United States and is the standard of care for managing early miscarriage. To date, nearly 7.5 million Americans have taken mifepristone. The attorneys general highlight the clear evidence of mifepristone’s safety, noting a “nearly nonexistent” fatality rate of 0.00048%, far outweighing the minimal risk of complications associated with early term abortions, which are related to abortion more generally, as opposed to mifepristone itself. Mifepristone is even on the World Health Organization’s core list of essential, life-saving medications. Despite this safety record, mifepristone remains subject to a REMS program designed for drugs with known, serious risks.

The petitioning 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.  

Under federal law, REMS requirements must mitigate a specific serious risk and cannot be “unduly burdensome” on patients or health care delivery systems.  AG Campbell and the coalition note that the restrictive REMS requirements, in addition to being unnecessary, also significantly reduce the distribution of mifepristone by qualified providers. 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. AG Campbell and the coalition also argue that the current mifepristone REMS are unnecessary because of robust state laws already in place in Massachusetts and other states that ensure safe prescribing, rigorous informed consent, and professional accountability. 

Given mifepristone’s strong safety record and essential role in abortion and miscarriage care, AG Campbell and the coalition assert that the current REMS program is both scientifically and legally indefensible. The attorneys general are asking the FDA to fully eliminate the mifepristone REMS program, including prescriber, pharmacy, and patient certification requirements; or, at minimum, cease applying REMS elements in New York, California, Massachusetts, and New Jersey—states where comprehensive healthcare, including abortion care, is highly regulated.