Health Law

5th Circuit faults FDA for expanding access to abortion drug; next move is up to SCOTUS

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AP mifepristone boxes_800px

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 U.S. Food and Drug Administration failed to address safety concerns when it expanded access to the abortion drug mifepristone in 2016 and 2021, according to the 5th U.S. Circuit Court of Appeals at New Orleans.

The 5th Circuit said expanded access to the drug should be rolled back, which would reinstate restrictions in place before 2016. Because of a prior order by the U.S. Supreme Court, however, the drug will remain available under current regulations, pending disposition of any cert petition by the high court, according to the Washington Post, the New York Times and Reuters.

At issue are FDA decisions that allow nonphysicians to prescribe mifepristone, allow the drug to be prescribed remotely, and allow the drug to be mailed to users.

The Alliance for Hippocratic Medicine had challenged the drug’s approval and subsequent decisions expanding access. Other plaintiffs included similar organizations and several doctors.

The doctors claimed that they have to perform abortions or facilitate that process when women have complications from mifepristone. Abortions violate the doctors’ “sincerely held moral beliefs.”

The 2016 changes:

  • Said women whose pregnancies have a gestational age of 70 days were eligible for the drug, up from 49 days previously approved./li>
  • Allowed nonphysicians to prescribe mifepristone
  • Removed the requirement for in-person administration of the drug and in-person follow-up
  • Ended prescribers’ obligation to report adverse events short of fatalities
  • Changed the dosage

The FDA made another change in 2021 that:

  • Allowed mifepristone to be prescribed remotely and sent via mail

Judge Jennifer Walker Elrod, an appointee of former President George W. Bush, wrote the Aug. 16 opinion, which partly upheld a decision by U.S. District Judge Matthew J. Kacsmaryk of the Northern District of Texas.

Elrod said it was too late to challenge FDA approval of mifepristone, and doctors had not shown that they were harmed by approval of a generic version of the drug in 2019. But she ruled for the challengers in their challenge to 2016 and 2021 changes.

Elrod said the FDA considered the impact of the 2016 changes separately but not their cumulative effect. And when the FDA decided that it didn’t have to collect data on nonfatal adverse events because of the drug’s low-risk profile, it failed to take into account that it was loosening restrictions on the drug’s use, Elrod said.

Elrod also faulted the FDA’s 2021 decision for depending on limited data.

“To be clear, the evidence does not show that mifepristone is unsafe in all applications,” Elrod wrote.

But at this preliminary stage, she said, the plaintiffs have made a substantial showing that the 2016 and 2021 changes “were taken without sufficient consideration of the effects those changes would have on patients.”

In a partial concurrence, Judge James C. Ho agreed that the 2016 and 2021 changes must be set aside as arbitrary and capricious. He also said the 2021 change was illegal under the Comstock Act, which makes it a crime to mail abortion drugs.

Ho would also have invalidated the initial approval of mifepristone.

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” “‘Dobbs is an indictment of women,’ past ABA president tells House in emotional testimony” “Justice Alito keeps full access to mifepristone in place pending briefing next week” “Why the 5th Circuit is allowing abortion pill sales but pausing expanded access to the drug”

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