US states sue FDA over access to abortion pills

A complaint filed by attorneys general from 12 Democrat-led states in the US is trying to force the FDA and Commissioner Robert Califf to relax restrictions on access to abortion drug mifepristone.

The lawsuit accuses the US drugs regulator of hampering access to mifepristone – used alongside misoprostol as a pharmacological way to end pregnancies – through an “onerous” risk evaluation and mitigation strategy (REMS).

While REMS are often deployed by the FDA to make sure patients are protected from potential harmful effects of new drugs and ensure they are used in accordance with the approved label, the AGs contend that with more than 22 years of use, the continued enforcement of a REMS for mifepristone is “excessive”.

They argue that the REMS used for mifepristone is a particularly burdensome form known as Elements to Assure Safe Use (ETASU), which strictly limit who can prescribe and dispense the drug.

“FDA’s decision to continue these burdensome restrictions […] 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,” says the complaint, filed in a US district court in Seattle.

“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 12 AGs note that their states have preserved the right to access abortion care as others across the country have moved to criminalise and civilly penalise abortion.

The FDA first approved the use of mifepristone with misoprostol as a two-drug regimen to terminate pregnancies in 2000.

The agency has taken steps to ameliorate the crackdown on abortion access in the wake of the overturning of Roe vs Wade, which stripped women in the US of their constitutional protection for the right to abortion - for example, by allowing mifepristone/misoprostol to be dispensed in retail pharmacies and via mail-order.

Those measures do not go far enough, according to Oregon AG Ellen Rosenblum, who is co-leading a lawsuit with Washington AG Bob Ferguson, who said the restrictions “expose patients to needless anguish and confusion.”

The restrictions also subject providers to bureaucratic oversight that makes providing care much more complicated than necessary, according to the AG.

“Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right,” added Rosenbaum.

The complaint is seeking an order directing FDA to follow the “science and the law” and remove the REMS restrictions.

Last month, a group of 25 House Republicans also challenged Califf and the FDA, saying its decision to relax the REMS to allow wider access was raising the chances of harm to pregnant people and turning “many post offices and pharmacies into abortion clinics.”