Twelve states led by Democrats are taking on the Food and Drug Administration over its unnecessarily harsh restricts on mifepristone, one of two drugs used for medication abortion. The suit is intended both to make the drug more accessible and to counter the expected injunction on the use of the drug that a district judge in Texas will hand down soon.
The suit is spearheaded by Oregon Attorney General Ellen Rosenblum and Washington Attorney General Bob Ferguson. In January, the FDA updated the risk evaluation and mitigation strategy (REMS) for mifepristone to life the requirement that patients pick the medicine up in person from a pharmacy, making it simpler for pharmacies to fill the prescriptions online and through the mail. But the FDA kept a requirement under REMS that forces prescribers to obtain specific certifications, and requires extensive documentation that the AGs say could endanger both providers and patients.
The paper trail “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,” the complaint states. That paperwork puts an unnecessary burden on healthcare providers and on patients, the AGs say in the suit.
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Under the REMS, both doctor and patient are required to sign an agreement saying that the drug is being prescribed and the patient intends to take it to end a pregnancy. It doesn’t distinguish between an abortion or treatment for a miscarriage, and that agreement stays in a patient’s medical record.
The lawsuit also points out that there are just 60 drugs among more than 20,000 regulated by the FDA that it has imposed REMS on, that “cover dangerous drugs such as fentanyl and other opioids, certain risky cancer drugs, and highdose sedatives used for patients with psychosis.” It is “improper and discriminatory for FDA to relegate mifepristone … to the very limited class of dangerous drugs that are subject to a REMS.”
“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 AGs lawsuit says. “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.”
“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 U.S.—is not unduly restricted,” Rosenblum said in a statement. “Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right.” The other states joining the suit, filed in the Eastern District of Washington state, are Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont.
“The federal government has known for years that mifepristone is safe and effective,” Ferguson said in a statement. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists, and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.”
A second drug, misoprostol, can also be used on its own to end a pregnancy, and it doesn’t have the same restrictions from the FDA as mifepristone. But the drugs are most effective when used in combination.
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