FDA sued by US states over abortion pill access
Attorneys general (AGs) from 12 Democrat-led US states have made complaints to the FDA in an attempt to force the body and commissioner Robert Califf to relax restrictions on access to abortion drug mifepristone.
Mifepristone is often used alongside misoprostol as a pharmacological way to terminate pregnancies, however this has been controversial recently with a previous complaint from 25 House Republicans claiming that the FDA’s decision to allow wider access to the drug was harmful to pregnant people and turned “many post offices and pharmacies into abortion clinics.”
The drug is regulated through its risk evaluation and mitigation strategy (REMS), which is usually used to protect patients from harmful effects of new drugs and to ensure new drugs are used in accordance with the approved label. The AGs claimed that mifepristone has been approved for 22 years, so the continued enforcement of REMS is “excessive.”
The complaint states: “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. […] 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 healthcare providers to dispense.”
Since the overturning of Roe vs Wade, which removed the constitutional protection for the right to abortion, the FDA has attempted to improve access to abortions, for example by allowing mifepristone/ misoprostol medication abortions to be dispensed by retail pharmacies and via mail order.
Ellen Rosenblum, Oregon AG, said the restrictions “expose patients to needless anguish and confusion. […] Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right.”