Massachusetts AG Campbell Pushes FDA to Drop Restrictions on Safe, Widely Used Abortion Medication
In a bold move to expand access to reproductive healthcare, Massachusetts Attorney General Andrea Joy Campbell—joined by her counterparts from California, New York, and New Jersey—has officially filed a Citizen Petition with the U.S. Food and Drug Administration (FDA), calling for the removal of unnecessary federal restrictions on mifepristone, one of the two medications used in early-term medication abortions.
So, what’s the issue here? Mifepristone, used alongside misoprostol, has been the standard protocol for medication abortions in the U.S. for over 25 years. It’s not only the preferred method for ending early pregnancies but also the gold standard for treating early miscarriages. Despite being used by nearly 7.5 million Americans with an extremely low fatality rate—just 0.00048%—this drug is still shackled by the FDA’s Risk Evaluation and Mitigation Strategy (REMS). The REMS program was originally designed for medications with known serious risks, which, as AG Campbell and her coalition point out, does not apply to mifepristone based on decades of safe and effective use.
The heart of their argument? These REMS restrictions are outdated, medically unnecessary, and legally questionable. And more than that—they’re actively hurting access. Because of REMS, only certain certified providers and pharmacies can prescribe and dispense mifepristone. That limits distribution, especially in rural areas, and acts as a deterrent for otherwise qualified medical professionals. In states like Massachusetts, where there are already robust laws governing medical practice, informed consent, and patient safety, this federal overlay is redundant at best—and obstructive at worst.
The timing of the petition also isn’t random. It’s a direct response to a recent directive from Health and Human Services Secretary Robert F. Kennedy Jr., who called for a “complete review” of mifepristone and its labeling. With that in the works, AG Campbell and her coalition are making it clear: the science supports mifepristone’s safety, and the current federal restrictions no longer make sense—scientifically, legally, or ethically.
They also make a sharp comparison: drugs like opioids, blood thinners, and even erectile dysfunction medications face fewer FDA hurdles than mifepristone, despite having greater risks of complications. Even other uses of mifepristone—such as for Cushing’s syndrome—are not bound by the same REMS requirements. That inconsistency, according to the petitioners, is indefensible.
The legal framework matters here too. Under federal law, REMS programs must address a specific, serious risk, and they can’t impose burdens that are disproportionate to the actual danger the drug poses. According to AG Campbell, the REMS program for mifepristone fails on both counts. It doesn’t align with the low-risk profile of the drug, and it places unjustified burdens on healthcare delivery—especially in regions already equipped with strong safeguards.
The petition doesn’t stop at an all-or-nothing ask. While the ideal outcome would be to completely eliminate the mifepristone REMS program, the coalition suggests an alternative: at the very least, remove REMS enforcement in highly regulated states like Massachusetts, California, New York, and New Jersey—places with strong healthcare infrastructures and legal protections for abortion care.
Bottom line: this isn’t just a legal technicality. It’s a public health issue. AG Campbell and her fellow attorneys general are pushing for a policy shift that recognizes the real-world safety of mifepristone and puts access and patient care ahead of outdated bureaucracy. Whether the FDA will respond—and how—remains to be seen, but one thing’s clear: the fight for science-based, equitable reproductive healthcare is far from over.
IF YOU NEED A LAWYER CONTACT US