A coalition of Democratic attorneys general are pushing the Food and Drug Administration to expand access to mifepristone, one of the drugs commonly prescribed to induce abortions — a bid to counter a high-profile attempt to restrict it in Texas.
This case has gotten significantly less coverage than anti-abortion groups’ efforts to revoke the FDA’s 20-year approval of the drug in Judge Matthew Kacsmaryk’s court in Amarillo, Texas. TPM first reported a transcript in the Texas case detailing the judge’s attempt to keep a major hearing off the public docket until the last minute to prevent protests.
In the AGs’ case, spearheaded by Washington state, the Democrats are pitted against the Democratic administration, which does not want to have to lift its restrictions on mifepristone. It relaxed some of those restrictions in January — including allowing certified pharmacies to dispense the drug rather than just individual providers — but kept many others. Major medical associations have long said that the restrictions, known as a Risk Evaluation and Mitigation Strategy, or REMS, are unnecessary; they’re usually reserved for drugs known to have addictive or dangerous qualities, like fentanyl.
TPM is first to report the transcript of the hearing held last week, which received scant media attention. The U.S. District Court in the Eastern District of Washington, where this case is being tried, does not livestream its hearings or provide a call-in number, making them difficult for smaller, non-local outlets to cover.
Kristin Beneski, an assistant Attorney General for Washington, said that the plaintiffs want two things: the FDA to have to keep the drug on the market in the states involved no matter what happens in the Texas case, and for the agency to be enjoined from enforcing the mifepristone REMS.
“This is pure preservation of the longstanding status quo, and it’s crucial in part because the FDA is a party to a case in Texas that seeks to undo its longstanding approval of this extremely safe and effective drug,” she argued.
Beneski said that access to the drug is more critical than ever before, given the anti-abortion regimes dominating many parts of the country.
Judge Thomas O. Rice jumped in at times, trying to lock down which REMS restrictions stem from the January 2023 modification, and which have long been on the books — perhaps a sign that he’s not buying the AGs’ attempt to use the January order to challenge all the restrictions, even the years-old ones.
Beneski attempted to underscore the arbitrariness that has always accompanied the mifepristone REMS.
“For abortion and miscarriage care, you take one 200-milligram pill one time. That is subject to onerous REMS restrictions,” she said. “If you take Mifepristone for Cushing’s disease, it’s a 300-milligram pill up to four times a day every single day over the long-term, and there are no REMS restrictions on that usage,” she added, calling it “the definition of arbitrary and capricious.”
Noah Katzen, representing the U.S. Attorney General’s office, argued that the plaintiffs have failed to show irreparable harm — saying that the January REMS modification made the drug more accessible, not less — and that they failed to exhaust all the potential administrative challenges they could have tried.
“Their relief would have to run against the final agency action,” he argued. “They’ve challenged the final agency action that they say is unlawful; so the question for redressability on standing is would an order that runs solely against the agency action that they are challenging here redress their injuries? They have offered no theory as to how it would. They have not alleged that it would.”
Rice jumped into Katzen’s arguments too, asking which other drugs require special pharmacy certification. Katzen couldn’t name one.
On rebuttal, Beneski argued that the harms involved are new since the Dobbs decision.
“Before the Dobbs decision, no one could be prosecuted for providing or facilitating an abortion or miscarriage care that might be characterized as an abortion,” she said. “That is an irreparable harm by itself to our state providers who have to sign these forms and who have to get certified and identify themselves as abortion providers and put themselves in danger by getting certified.”
Rice promised a decision as “promptly” as he can.
Meanwhile, court watchers still have their eyes on Amarillo, waiting for Kacsmaryk’s expected decision to revoke the FDA’s approval of mifepristone. Some, including Sen. Ron Wyden (D-OR), have called on the administration to ignore Kacsmaryk’s decision and keep the drug on the market anyway, as many are that lack FDA approval. He confirmed to TPM that he’s shared his idea with the White House; the White House has not responded to TPM’s questions.
Read the transcript from the Democratic AGs’ case here:
