Dem AGs clash with Biden admin over abortion pill restrictions

The Biden administration is fighting a Democratic-led effort to make abortion pills more accessible even as it simultaneously opposes a GOP-led effort to ban the drugs nationwide.

Lawyers representing the FDA are expected in court on Tuesday to defend the agency’s authority to place certain restrictions on mifepristone, which is typically used to end a pregnancy during the first 10 weeks. The case before the U.S. District Court for the Eastern District of Washington was brought by more than a dozen Democratic state attorneys general who say the requirements around the drug, including a certification process for anyone prescribing it, place an undue burden on patients and providers.

“I'm just not going to put up with an FDA that places unreasonable and illegal limitations on this important medication,” Washington State Attorney General Bob Ferguson, who is leading the coalition, said in an interview. “I understand I'm filing a lawsuit against an administration that I respect and a president who I admire, but that's beside the point. They have restrictions in place that are real, that have an impact and that need to be eliminated.”

Should the judge rule in their favor, the case could eliminate restrictions in those states — broadening access to the drug for tens of millions of people. But the oral arguments also come as a federal judge in Texas is set to rule on whether to ban the pills entirely, and the potential for clashing federal court decisions could push the issue to the U.S. Supreme Court, which overturned Roe v. Wade in June.

The Biden administration has repeatedly criticized GOP officials and corporate entities in recent months for moving to curb access to abortion pills — noting that they have been deemed safe and effective by the FDA for nearly 25 years and have become the most popular way of terminating a pregnancy in the U.S.

Yet it is also in court fighting to maintain restrictions on the pills known as REMS — or Risk Evaluation & Mitigation Strategies — that the FDA places on a narrow class of drugs. Namely, Biden administration is defending requirements that patients sign a “Patient Agreement Form” acknowledging the risks of the medication and that health care providers who prescribe the drug first obtain certification and prove they can accurately date pregnancies, diagnose ectopic pregnancies, and provide or arrange for a follow-up care if needed.

The FDA declined to comment on the case, citing the ongoing litigation.

Oregon Attorney General Ellen Rosenblum is co-leading the lawsuit with Ferguson, and they are joined by the Democratic attorneys general representing Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.

The pill restrictions, the group claims, are burdensome for both patients and doctors and the documentation requirements put them at risk for harassment or violence.

The Justice Department, meanwhile, is arguing that the attorneys general challenging the FDA rules waited too long to do so, didn’t follow the proper procedure and have failed to prove the remaining pill restrictions are harming patients in their states.

“They cannot credibly claim to be irreparably harmed by FDA’s decision to retain two 22-year-old requirements,” Biden administration attorneys wrote in a brief filed earlier in March. “Their delay shows that any harm is not so significant as to justify a preliminary injunction that would upset the status quo.”

Even as the Democratic officials and the FDA face off in Washington State on Tuesday, they’re on the same side in the Texas case, arguing that the anti-abortion groups suing the agency have no standing, haven’t proved the pills are causing harm and are infringing on the FDA’s authority to regulate the drugs. The same group of Attorneys General, plus several others, submitted amicus briefs in the Texas case backing the FDA rules around abortion medication.

When the FDA originally approved mifepristone for market in 2000, after many years of debate, the agency said the pills could only be dispensed in person by a certified physician. The Biden administration has acted multiple times to loosen those restrictions. In 2021, soon after Biden took office, the FDA allowed the drugs to be prescribed via telemedicine and delivered by mail — at first only for the duration of the Covid-19 pandemic and then permanently. Then, this January, the FDA announced that retail pharmacies could dispense the pills to patients with a prescription and the Justice Department reaffirmed that mailing the pills is not considered a federal crime under the Comstock Act.

Still, Ferguson and his fellow attorneys general argue the remaining restrictions on the pills are not justified given their well-documented safety record and lower rate of complications compared to many other over-the-counter medications. They also say the restrictions prevent providers in their states from serving both their own residents and the high volume of patients coming in from states with abortion restrictions.

“The FDA has approved over 20,000 drugs without limitations. So why is mifepristone listed along with fentanyl as one of only 60 drugs that have limitations?” he said. “It doesn't make sense from a science perspective. And that's why we think we're going to prevail.”