FDA Food Overhaul

FILE - A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. (AP Photo/Manuel Balce Ceneta, File)

(The Center Square) - Oregon Attorney General Ellen Rosenblum is leading a lawsuit with Washington Attorney General Bob Ferguson against the Food & Drug Administration (FDA) for what they think is overregulation of abortion pills.

Rosenblum and Ferguson are leading a 12-state coalition in the suit. The Attorneys General are seeking a preliminary injunction asking the FDA to stop subjecting mifepristone to its Risk Evaluation & Mitigation Strategies, or REMS rules.

“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 attorneys general wrote in their complaint. “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.

“Not only that, but the REMS require burdensome documentation of the patient’s use of mifepristone for the purpose of abortion, making telehealth less accessible and creating a paper trail that puts both patients and providers in danger of violence, harassment, and threats of liability amid the growing criminalization and outlawing of abortion in other states,” they added.

Rosenblum’s office noted that the 4,246 chemical abortions in Oregon in 2021 were about 60 percent of the state’s total abortions. The FDA first approved mifepristone to be used in conjunction with misoprostol for abortions in 2000. Before they were the most common abortion method, surgical abortions were more prevalent.

“In this time when reproductive healthcare is under attack, our coalition of 12 states seeks to ensure that access to Mifepristone – the predominant method of safe and effective abortion in the US – is not unduly restricted,” Attorney General Rosenblum said in a press release issued by her office. “Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right.”

Abortion pill providers must receive certification from the drug distributor, and patients and providers must sign an agreement certifying that the patient has agreed to take these drugs. Additionally, pharmacies must receive certification before they can dispense mifepristone prescriptions.

The coalition filed the lawsuit in U.S. District Court for the Eastern District of Washington. Other than Washington and Oregon, states that joined the lawsuit include: Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, New Mexico, Nevada, Oregon, Rhode Island, and Vermont.