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Oregon, Washington lead coalition of 12 states in suing FDA over abortion pill restrictions


Oregon, Washington lead coalition of 12 states in suing FDA over abortion pill restrictions

Feb 24, 2023 | 2:16 pm ET
By Ben Botkin
Oregon, Washington lead coalition of 12 states in suing FDA over abortion pill restrictions
Ellen Rosenblum is Oregon's attorney general. (Courtesy of Ellen Rosenblum)

A group of a dozen state attorneys general, including Oregon Attorney General Ellen Rosenblum, is suing the Food and Drug Administration, alleging the federal agency is excessively regulating an abortion pill. 

Rosenblum and Washington Attorney General Bob Ferguson are spearheading the lawsuit, announced Friday. The complaint alleges that the federal agency has singled out mifepristone, an abortion pill, for restrictions that create more documentation and bureaucracy and make it harder for patients to access and pharmacies to fill. 

The other 10 states to join the lawsuit, filed in the U.S. District Court for the Eastern District of Washington, are: Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, New Mexico, Nevada, Rhode Island and Vermont.

“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.”

Those restrictions, called Risk Evaluation & Mitigation Strategies, are intended to only apply to dangerous drugs, like fentanyl and high-dose sedatives, Rosenblum’s office said. They require more paperwork for providers, pharmacies and patients. Only 60 drugs of more than 20,000 FDA-approved prescription drugs have such restrictions in place, according to the lawsuit.

For example, the requirements make it harder for patients to access the drug by having a telehealth, which enables prescribers to reach patients far from a clinic, the lawsuit alleges. The requirements leave 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,” the lawsuit alleges.

Paperwork requirements take up more provider time and put patients through more anguish, the lawsuit alleges. Specifically, patients and providers must also sign an agreement that certifies the patient has decided to take the drugs to end their pregnancy, regardless of whether they are taking the drug for an abortion or treatment of a miscarriage. That agreement stays in their medical records.

In 2000, the FDA approved mifepristone, to be used with drug misoprostol, in a two-drug regimen to end an early pregnancy. The pills can be taken at home with a prescription and are available through Planned Parenthood and other providers. It can also be used for some, but not all, pregnancy complications and miscarriages.

The lawsuit alleges the FDA’s decision to continue the restrictions in January 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 health care providers to dispense,” the lawsuit alleges.

In 2021, 4,246 medication abortions were administered by Oregon medical providers, according to the lawsuit. That was about 60% of all abortions in the state.

The lawsuit says Oregon is not aware of any patient in the state who has experienced serious adverse effects or died after taking the medication.

The lawsuit seeks a preliminary injunction to stop FDA enforcement of the additional restrictions while the lawsuit is pending. It coincides with a case in Texas seeking a ban of mifepristone. That case is closely watched, as it could lead to an injunction that would impact access for the entire nation.

Earlier this month, Rosenblum, as one of 23 attorneys general, supported the decision of Walgreens and CVS pharmacies to provide abortion pills by mail after the FDA enacted a rule change that will allow retail pharmacies to dispense mifepristone to patients with a prescription.