DOJ and mifepristone drugmaker go to SCOTUS with medication abortion access fight

September began — and the week ended — with a flurry of legal news.

Sep 10, 2023

On Friday evening, the Justice Department and Danco Laboratories both asked the U.S. Supreme Court to hear cases over access to mifepristone, one of the two drugs used in medication abortions. The moves — particularly from the Biden administration — make it increasingly likely both that the justices will hear the case and that a ruling in the case would come by June 2024.

The filings followed the decision last month from the U.S. Court of Appeals for the Fifth Circuit holding that the challenge to the original 2000 approval by the U.S. Food and Drug Administration was too late, but that the 2016 and subsequent loosening of restrictions, including the decision to end the in-person dispensing requirement, were timely and would likely succeed. As such, the Fifth Circuit would put the restrictions on the drug’s use back to where they were before the 2016 changes — restrictions that would make the drug inaccessible to many.

Current access standards have continued, however, under the U.S. Supreme Court’s April 21 order in the case, which came in the quick aftermath of the initial April 7 ruling from U.S. District Judge Matthew Kacsmaryk purporting to halt the initial approval of the drug, its generic version, and the later loosening of restrictions. The Supreme Court ordered that none of Kacsmaryk’s order would go in effect while the case was on appeal and that the current standards would remain in effect until the Supreme Court had its say in the case — either by taking the case when it came to the justices and ruling on it or by declining to hear the case when asked.

All of that is to say that, on Friday, DOJ and Danco Laboratories, the maker of Mifeprex, asked.

Those requests — petitions for a writ of certiorari — were more limited than they otherwise might have been due to the fact that even two judges of the conservative Fifth Circuit panel (Judges Jennifer Elrod and Cory Wilson) held that Kacsmaryk went too far in purporting to halt the original approval of mifepristone. As such, DOJ and Danco are only asking the justices to rule on issues relating to the 2016 and 2021 decisions loosening restrictions on mifepristone’s use.

Here’s how the Biden administration is framing the case on behalf of the FDA in DOJ’s petition:

(I) QUESTIONS PRESENTED This case concerns mifepristone, a drug that the U.S. Food and Drug Administration (FDA) approved in 2000 as safe and effective for terminating early pregnancies. The Fifth Circuit held that respondents—doctors and associations of doctors who oppose abortion—have Ar- ticle III standing to challenge FDA’s 2016 and 2021 ac- tions with respect to mifepristone’s approved conditions of use and that those actions were likely arbitrary and capricious. The court therefore affirmed the district court’s stay of the relevant agency actions. The ques- tions presented are: 1. Whether respondents have Article III standing to challenge FDA’s 2016 and 2021 actions. 2. Whether FDA’s 2016 and 2021 actions were arbi- trary and capricious. 3. Whether the district court properly granted pre- liminary relief.

Here’s how Danco Laboratories framed the case in its petition:

QUESTIONS PRESENTED In 2000, the Food and Drug Administration (FDA) approved Danco’s drug Mifeprex for termination of early pregnancy based on the agency’s expert judg- ment that clinical data showed the drug to be safe and effective. The agency later modified certain condi- tions of use for mifepristone in 2016 and 2021, again relying on clinical data and the agency’s expert judg- ment that the drug would remain safe and effective under the modified conditions of use. In 2022, associ- ations of doctors who have never prescribed Mifeprex sued FDA, arguing that FDA’s actions modifying the drug’s conditions of use in 2016 and 2021 violated the Administrative Procedure Act. The questions pre- sented are: 1. Whether an association can demonstrate Article III standing to enjoin a government action by arguing that some unspecified member may be injured at some future time by the challenged action; and 2. Whether the Fifth Circuit erred in upholding the preliminary injunction of FDA’s 2016 and 2021 ac- tions based on the court’s review of an incomplete ad- ministrative record.

Altogether, then, there really are four questions being brought to the justices:

Do the challengers have standing to bring the case?
Did the 2016 and 2021 decisions violate the Administrative Procedure Act?
Was Kacsmaryk’s remedy, purporting to halt the rules’ effective date, proper?
Was the Fifth Circuit’s decision proper, given that it was made without the benefit of the complete administrative record?

The justices will now get briefing from others, parties and others, on the question of whether the court should grant certiorari and hear the case. It’s also possible that there will be a cross-petition for certiorari from the challengers to mifepristone — a request that would almost certainly ask the court to reconsider the Fifth Circuit’s ruling on the original 2000 approval as well. In addition to Danco, meanwhile, GenBioPro, the maker of the generic mifepristone, has been involved in this case through amicus briefing despite not being a party to the case.

The justices could be deciding whether to hear the case — and what parts of the case to hear — as soon as their private conference on Oct. 27, but it is likely the decision won’t come until November or later if there is a cross-petition and/or if any parties seek an extension. Regardless, it’s almost certain that a decision would come in time for the justices to hear the case this coming term that begins next month, which would mean another round of briefing, arguments by April 2024, and a decision expected by June 2024.

The other news

It has been a busy few legal days.

The big news early in the day was the release of the Fulton County special purpose grand jury’s final report. The special purpose grand jury had recommended that Fulton County District Attorney Fani Willis seek indictments of several people not indicted in her recently begun prosecution.

Among the biggest names in the report against whom indictments had been recommended were Sen. Lindsey Graham and former Sens. Kelly Loeffler and David Perdue. Attorney Cleta Mitchell was also named, as were Michael Flynn and Lin Wood. [Read more, including specifically about the Loeffler and Perdue mentions, from the Atlanta Journal-Constitution.]

Later in the day, Mark Meadows lost his attempt to have Willis’s prosecution removed to federal court. He has already filed a notice that he is appealing that decision to the U.S. Court of Appeals for the Eleventh Circuit. [Read more from NBC News.]

The U.S. Court of Appeals for the Fifth Circuit — in an unsigned order from a three-judge panel consisting of Judges Edith Clement, Jennifer Elrod, and Don Willett — partially affirmed the July 4 social media-influence ruling against the Biden administration. The appeals court held that the district court was not wrong in finding that the White House, the Surgeon General, the CDC, and the FBI “likely coerced or significantly encouraged social-media platforms to moderate content.” As such, the appeals court agreed that “render[ed] those decisions state actions,“ likely violating the First Amendment.

The appeals court, however, went on to hold that the initial injunction issued by U.S. District Judge Terry Doughty went way too far, instead cutting it down to one much more limited injunction that applies to fewer people. The remaining injunction limits White House and other officials as follows:

[Read more from The Washington Post and Eugene Volokh.]

New Mexico Gov. Michelle Lujan Grisham, a Democrat, issued a public health emergency-based executive order addressing gun violence and drug use. A subsequent order issued Friday from the secretary of the New Mexico Department of Health, acting on Lujan Grisham’s order, temporarily bans the right to carry firearms in Albuquerque, among other steps. In announcing the move, the governor stated that “the time for standard measures has passed.” The National Association for Gun Rights filed a lawsuit against Lujan Grisham and the health secretary, Patrick Allen, in federal court over the weekend. The plaintiffs are seeking a temporary restraining order. [Read more about the order from The New York Times.]

Finally: Don’t worry. I didn’t miss (and haven’t forgotten about) Justice Sam Alito’s latest. (Or Sunday’s news, for that matter.) More on all of that to come here soon enough.