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Several Democratic states sue FDA over abortion pill restrictions

Twelve attorneys general say the federal agency's "unscientific" stance "endangers" doctors, pharmacists and women.

Doce fiscales generales demócratas denuncian a la FDA por las restricciones a las píldoras abortivas.

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Published by
Israel Duro

The attorneys general of 12 Democratic states filed a complaint against the U.S. Food and Drug Administration (FDA) over the agency's restrictions on mifepristone, the drug most commonly used to perform chemical abortions. According to the plaintiffs, "there is no scientific basis" for placing this drug on the same level as fentanyl.

The main driver of the lawsuit is Washington state Attorney General Bob Ferguson, backed by his colleagues in Oregon, Nevada, Delaware, Arizona, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan, and Rhode Island. The complaint was filed in the U.S. District Court for the Eastern District of Washington. In it, the plaintiffs claim that a drug that has been proven "safe and effective" for two decades continues to be included in the Risk Evaluation and Mitigation Strategy (REMS). This qualification makes its prescription and use strictly limited.

Danger of harassment and threats for doctors and women

Ferguson argues that the FDA "has only imposed REMS for 60 of the more than 20,000 FDA-approved prescription drugs marketed in the U.S. These cover dangerous drugs such as fentanyl and other opioids, certain risky cancer drugs, and highdose sedatives used for patients with psychosis." According to Ferguson, mifepristone, which is used in 53% of chemical abortions nationwide because of its safety and efficiency, should not fall under this umbrella of restrictions.

The plaintiffs feel that this endangers doctors, pharmacists and women who choose to have an abortion:

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. Not only that, but the REMS require burdensome documentation of the patient’s use of mifepristone for the purpose of abortion, making telehealth less accessible and creating a paper trail that 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.

"Threat to abortion access"

Ferguson emphasized in his argument that the removal of these restrictions is vital to defend the alleged right to abortion, based on the Supreme Court ruling that overturned Roe vs. Wade. In January, the FDA authorized mifepristone in some retail pharmacies, but this does not appear to be not enough for the plaintiffs.

The availability of medication abortion has never been more important. As states across the country have moved to criminalize and civilly penalize abortion, the Plaintiff States have preserved the right to access abortion care, and have welcomed people from other states who need abortion care. The extremely limited availability of abortion in other states, and the growing threat to abortion access  nationwide, makes patients’ access to medication abortion paramount. Medication abortion through a combination of mifepristone and misoprostol is the “gold standard” for early termination of  pregnancy, used by the majority of people in the U.S. who choose to have an abortion.

FDA also sued in Texas for opposite reason

Although not cited, one of the reasons for the Democrats’ urgency to move forward with the lawsuit is a separate lawsuit that the Alliance Defending Freedom (ADF) filed in federal court in Texas. This second lawsuit was also filed against the FDA, though for the opposite reason. ADF acted on behalf of four national medical associations and several physicians, arguing that the federal agency "chose politics over science and approved abortifacient chemical drugs for use in the United States." The lawsuit points to six discrete agency actions since the legalization of mifepristone and misoprostol in 2000 and asks the court to declare those actions illegal.

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