ATTORNEY GENERAL Andrea Campbell implored federal regulators Thursday to eliminate medication abortion restrictions on prescribers and pharmacies, arguing Massachusetts already has “robust” guardrails in place to protect patient safety.
Campbell, along with AGs from California, New York and New Jersey, want the US Food and Drug Administration to eliminate its Risk Evaluation and Mitigation Strategy (REMS) program for mifepristone — or at least stop applying certain parts of it to the four petitioning states. The program outlines certification requirements for health care providers and pharmacies to dispense mifepristone, plus paperwork that patients must sign.
About 65% of abortions in Massachusetts in 2023 were medication abortions, according to the 64-page citizen petition Campbell co-filed Thursday.
The FDA says REMS programs are used for drugs with “serious safety concerns to help ensure the benefits of the medication outweigh its risks.” Campbell’s office contends the mifepristone requirements impose “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 Mifepristone REMS Program also imposes an undue burden on pregnant patients experiencing miscarriage and early pregnancy loss who seek treatment at emergency departments,” the petition says. “For instance, the administrative requirements imposed by the REMS can effectively discourage emergency departments from carrying mifepristone in their pharmacies.”
Reduced access to mifepristone can particularly impact patients in rural and medically underserved areas, the petition added.
The Democratic AGs teamed up in response to US Health and Human Services Secretary Robert Kennedy recently instructing FDA Commissioner Martin Makary to pursue a “complete review” of mifepristone and labeling requirements.
In response to the Trump administration, Beacon Hill lawmakers are escalating their focus on shoring up protections for reproductive and transgender care. A Sen. Cindy Friedman bill (S 2522) that’s gaining traction would tighten the 2022 abortion shield law, including by requiring hospitals to provide emergency abortion care and allowing provider practices, rather than specific prescriber names, to appear on medication abortion labels.