A dozen Democratic state attorneys general are suing the FDA in order to make it easier to access the drug. They allege FDA is overregulating mifepristone, and the agency’s required safety program puts up too many obstacles.
“Access to the medication is unnecessarily limited and restricted, leading to medical care delays and other hurdles for both patients and providers,” the Democratic AGs said.
It’s the latest salvo in the fight over access to medication abortion and comes as a federal judge in Texas is poised to decide whether to completely remove mifepristone from the market.
Mifepristone is regulated under a Risk Evaluation and Mitigation Strategy (REMS), a safety program the agency required for certain drugs to ensure their benefits outweigh their risks. According to the lawsuit, spearheaded by Oregon Attorney General Ellen Rosenblum (D) and Washington Attorney General Bob Ferguson (D), only about 60 FDA-approved drugs are subject to REMS.
Under the program, providers must be specially certified by the drug distributor. Additionally, providers and patients are required to certify the patient plans to take mifepristone to end their pregnancy, regardless of whether they want an abortion or are treating for a miscarriage. Pharmacies also cannot fill prescriptions for mifepristone unless they are specially certified.
“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 lawsuit states.
Removing the program from mifepristone is something reproductive rights activists have been loudly calling for, especially in light of the Supreme Court’s decision last summer to overturn Roe v. Wade.
Senate Democrats have also urged the FDA to lift restrictions on mifepristone. With Republicans in control of the House and with a majority of only 51 seats in the Senate, Democrats are unlikely to be able to take action on the issue unless through executive authority.
