Democratic attorneys general sue FDA over ‘burdensome’ restrictions on abortion pills

A group of Democratic state attorneys general have filed a lawsuit against the Food and Drug Administration (FDA), accusing the agency of not doing enough to ensure the accessibility of the abortion medication mifepristone as a separate Texas lawsuit proceeds with the potential to ban the drug altogether.

The lawsuit brought against the FDA seeks to get rid of the Risk Evaluation and Mitigation Strategy (REMS) that is applied to mifepristone. The REMS is a drug safety program required for a select medications and meant to ensure that the benefits of the drugs outweigh the risks.

The plaintiffs, coming from states where abortion services are still largely accessible, argue that the REMS for mifepristone has “no basis in science” and is burdensome due to the restrictions it places on who can prescribe and dispense the abortifacient.

“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,” the suit stated.

The documentation for mifepristone use necessitated by its REMS also puts patients at risk of violence and harassment, the plaintiffs further argued.

The lawsuit asks that the FDA declare mifepristone to be safe and effective and that the court find the REMS for mifepristone to be unlawful. The lawsuit is also seeking to block the FDA from removing mifepristone from the market or reducing its availability.

A group of Democratic senators led by Elizabeth Warren (D-Mass.) and and Bernie Sanders (I-Vt.) similarly called on the Biden administration to make access to medication abortions easier last year.

Mifepristone was approved by the FDA more than 20 years ago. The agency considers mifepristone to be safe when use of the drug is consistent with the REMS.

Like all medications, mifepristone can cause adverse reactions, which can include heavy bleeding and blood clots as well as the potential for the drug to not end a pregnancy. The rate of adverse reactions is rare, however, with complications only occurring in about 5 percent of medical abortions that happened following appropriate in-person evaluations.

Many abortion access advocates and medical groups have argued that acetaminophen, a common over-the-counter pain reliever, has a higher rate of complications than mifepristone and causes about 500 deaths per year in the U.S.

Mifepristone is currently at the center of a federal lawsuit in Texas that could determine whether the drug will be available anywhere in the U.S. This suit was filed by the conservative legal group Alliance Defending Freedom on behalf of multiple anti-abortion medical organizations.

If U.S. District Judge Matthew Kacsmaryk, a Trump-appointee presiding over the case, decides in favor of Alliance Defending Freedom, then the FDA would be forced to rescind approval for mifepristone more than two decades after it was approved.