Health Law

'I don't understand this theme that FDA can do no wrong,' says 5th Circuit judge on mifepristone approval

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Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama, on March 16, 2022. The drug was approved by the Food and Drug Administration in 2000. Photo by Allen G. Breed/The Associated Press.

The 5th U.S. Circuit Court of Appeals at New Orleans on Wednesday appears ready to restrict approval of the abortion medication mifepristone.

During oral arguments Wednesday, Judge James Ho disagreed with a Department of Justice lawyer’s assertion that “it’s not a court’s role to come in and second-guess” the expertise of the U.S. Food and Drug Administration.

“I don’t understand this theme that FDA can do no wrong,” Ho said. “We are allowed to look at the FDA just like we’re allowed to look at any agency. That’s the role of the courts.”

The Washington Post, the New York Times, the Associated Press, Reuters and Rolling Stone covered the arguments.

The FDA approved mifepristone in 2000 and expanded access to the drug in later decisions. Those later decisions allow mifepristone to be sold at retail pharmacies, to be dispensed by mail and to be prescribed by nonphysicians.

The Washington Post reports that the 5th Circuit panel’s questioning was less aggressive when a lawyer representing groups of anti-abortion doctors was arguing. And a lawyer for the drugmaker was chastised for language in brief criticizing a ruling that blocked access to the drug by U.S. District Judge Matthew J. Kacsmaryk of the Northern District of Texas.

Kacsmaryk had concluded that the FDA “acquiesced on its legitimate safety concerns” when it approved the drug.

U.S. Circuit Judge Jennifer Walker Elrod read aloud from briefs filed for drugmaker Danco Laboratories, which called Kacsmaryk’s ruling an “unprecedent judicial assault” and referred to his “relentless one-sided narrative.”

Elrod said those kinds of comments “we normally don’t see from learned counsel.”

“You think it’s appropriate to attack the district court, personally, in that kind of way?” Elrod asked.

Other issues in the case are whether the plaintiffs have standing to challenge the FDA’s decision and whether their lawsuit was filed too late to challenge initial approval of the drug.

The plaintiffs are anti-abortion doctors and medical associations who argue that they will have to perform emergency care, including surgical abortions, when the drug does not end the pregnancy or causes complications.

The U.S. Supreme Court has kept access to the drug in place during the litigation.

The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

See also: “Alito keeps abortion drug access in place to give SCOTUS more time to act on emergency request” “Justice Alito keeps full access to mifepristone in place pending briefing next week”

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