Why the 5th Circuit is allowing abortion pill sales but pausing expanded access to the drug Goodness99

Health Law

Why the 5th Circuit is allowing abortion pill sales but pausing expanded access to the drug

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.

Updated: Anti-abortion doctors and medical associations likely sued too late to revoke the U.S. Food and Drug Administration’s 2000 approval of the abortion pill mifepristone, a federal appeals court has ruled in temporarily staying part of an April 7 decision by U.S. District Judge Matthew J. Kacsmaryk of Texas.

But the six-year statute of limitations won’t bar the plaintiffs’ challenge to later decisions by the FDA expanding access to the drug, the 5th U.S. Circuit Court of Appeals at New Orleans concluded in a decision issued late Wednesday.

As a result, the 5th Circuit unanimously allowed access to mifepristone pending appeal. But the panel voted 2-1 to keep in place Kacsmaryk’s decision blocking the FDA’s later decisions that expanded access to the drug.

Though some of those later decisions were made in 2016, the FDA didn’t respond to a petition challenging the changes until December 2021. That is when the clock started ticking on the limitations period, the 5th Circuit said.

The doctors had argued that the later changes were arbitrary and capricious. It is unlikely that the argument will fail, the appeals court said in the April 12 decision.

The New York Times, the Washington Post, CNN, Politico and Bloomberg Law have coverage.

The U.S. Department of Justice will ask the U.S. Supreme Court for emergency relief, the Washington Post reports.

Politico described the later-approved policies that will remain temporarily blocked under the 5th Circuit’s decision. They include allowing mifepristone to be used for up to 10 weeks of pregnancy, rather than seven weeks, allowing retail pharmacies to sell the drug, allowing the drug to be dispensed by mail, lifting the requirement for in-person doctor visits, allowing prescriptions by telemedicine, and allowing nonphysicians to prescribe the drug.

Some critics and the DOJ had argued that the physicians did not have standing to challenge the FDA’s actions because they did not show that they personally face an imminent risk of concrete and particularized injury. But the 5th Circuit disagreed.

Some of the plaintiffs are emergency room doctors who will have to perform emergency care, including surgical abortions, when the drug does not end the pregnancy or causes complications, the 5th Circuit said.

“And this harm is not speculative. Several doctors confirmed that they have had to surgically complete an abortion or remove an unborn child,” the appeals court said.

The 5th Circuit said its holding on standing was narrow, however.

“We do not hold that doctors necessarily have standing to raise their patients’ claims,” the appeals court said. “We do not hold that doctors have constitutional standing whenever they’re called upon to do their jobs. And we do not hold that doctors have standing to challenge FDA’s actions whenever the doctor sees a patient experiencing complications from an FDA-approved drug. Rather, we hold that on the record before us applicants know that hundreds of thousands of women will—with [the FDA’s] own statistical certainty—need emergency care on account of [the FDA’s] actions. And because [the FDA] chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences.”

The 5th Circuit also indicated that the plain text of the Comstock Act of 1873 bans knowing use of the mail for an abortion drug. But the appeals court added that “the speed of our review does not permit conclusive exploration of this topic.”

The judges in the majority were Judge Kurt Engelhardt and Judge Andrew Oldham, nominees of former President Donald Trump. Judge Catharina Haynes, a nominee of former President George W. Bush, would have temporarily stayed Kacsmaryk’s entire decision.

Politico and other publications noted that the 5th Circuit used phrases such as “chemical abortion” and “unborn child” in its opinion—terminology often associated with the anti-abortion movement.

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

See also:

ABAJournal.com: “Can court ban abortion pill? Federal judge considers authority, plaintiffs’ standing”

Updated April 13 at 11:10 a.m. to report that the government will seek review from the U.S. Supreme Court.

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