State attorneys general sue FDA over abortion pill access restrictions
A dozen Democrat attorneys general are suing the FDA in federal court in the Eastern District of Washington to remove all restrictions on mifepristone, a pill used in combination with another medicine to end early pregnancies.
The suit comes as a Trump-appointed Texas federal judge is expected to soon decide on whether the pill should be pulled from the market. Mifepristone is currently used in more than half of all US abortions, according to the Guttmacher Institute. Democrat Senators have urged US Attorney General Merrick Garland to quickly prepare an appeal to the decision.
State attorneys general from Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont indicated in their suit that the FDA has singled out mifepristone with an unnecessary warning, or REMS, on its label.
“This case is about whether it is improper and discriminatory for FDA to relegate mifepristone—a medication that has been used over 5 million times with very low rates of complications, very high rates of efficacy, and which is critical to the reproductive rights of the Plaintiff States’ residents, as well as visitors who travel to the Plaintiff States to seek abortion care—to the very limited class of dangerous drugs that are subject to a REMS,” the complaint reads.
The FDA has already loosened some restrictions around mifepristone since its approval in 2000. In a major recent change, the FDA said it would allow certain certified pharmacies to dispense mifepristone. Patients still need a prescription to receive the drug, though they aren’t required to see a healthcare provider in person to get one, the FDA specified.
But the AGs maintained that the FDA has continued to hamper access by singling out mifepristone “for a unique set of restrictions” with its REMS.
“FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” the suit says. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.”
Two weeks ago, more than a dozen food and drug law experts also argued that if the Texas ruling happens and mifepristone is pulled from the market, the entire drug approval process could be hamstrung by politics.
Their arguments are in response to a November 2022 Texas lawsuit filed by the Alliance for Hippocratic Medicine challenging the 2000 approval of mifepristone. The FDA has already urged the Trump-appointed Judge Matthew Kacsmaryk, who is presiding over the case, to reject a preliminary injunction filed by abortion opponents to withdraw the approval for the drug.
The FDA declined to comment.