By Jonathan Stempel
(Reuters) -Abortion opponents on Tuesday urged a federal appeals court to allow the suspension of the Food and Drug Administration’s approval of the abortion pill mifepristone, in a case with potentially far-reaching impact on how the U.S. government regulates medicine.
In a filing with the 5th U.S. Circuit Court of Appeals in New Orleans, lawyers for groups and doctors who oppose abortion and challenged the FDA’s more than two-decade-old approval of the drug said a government request to stay the suspension was “extraordinary and unprecedented” and should be denied.
The plaintiffs reiterated their arguments that the FDA failed to adequately consider the drug’s risks, including complications requiring hospital visits and psychological harm.
They said doctors “will continue to spend their limited time, energy, and resources dealing with the tragic effects of these dangerous drugs, and suffer spiritual and emotional distress from these tragic events.”
The abortion opponents’ requests came one day after the U.S. Department of Justice urged the appeals court to put U.S. District Judge Matthew Kacsmaryk’s April 7 order voiding the FDA’s approval on hold through the appeals process.
Kacsmaryk, a judge in Texas appointed by Republican then-President Donald Trump, had issued only a seven-day stay.
The groups and doctors are led by the Alliance for Hippocratic Medicine, which was formed last August. It was not clear when the 5th Circuit would rule on extending the stay.
Mifepristone is the first pill in a two-drug regimen for medication abortions used in more than half of all U.S. abortions. Several states have announced plans to stockpile mifepristone or the other drug, misoprostol.
The Justice Department said on Monday that mifepristone was safe, and that Kacsmaryk’s decision would “thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”
Several hundred drug and biotechnology company executives not involved in making mifepristone on Monday called for a reversal of the judge’s decision, saying they count on the FDA’s autonomy and authority to approve new drugs for patients.
“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” they said.
Some of the same executives joined in a formal friend-of-the-court brief filed Thursday.
The case has drawn numerous other briefs.
Twenty-three mostly Democratic-led states plus 28 municipalities including Washington, Baltimore, Boston and Los Angeles and most Democratic members of Congress weighed in with briefs urging the appeals court to stay Kacsmaryk’s ruling.
So did major public health and medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, along with more than dozens of abortion providers and advocacy groups supporting abortion rights, including Planned Parenthood.
Many others backed the judge’s decision, including anti-abortion groups, 19 Republican-led states and 69 Republican members of Congress who said the FDA’s actions posed serious risks to women and girls seeking “chemical abortions,” a term the judge also used.
Kacsmaryk, based in Amarillo, Texas, ruled that the FDA exceeded its authority by ignoring mifepristone’s risks and relying on “plainly unsound reasoning” when approving it.
Eighteen minutes later, a federal judge in Washington state issued a contradictory ruling directing the FDA to keep the drug available in 17 states and Washington, D.C.
If the split persists, the U.S. Supreme Court may be asked to resolve the matter.
Federal appeals courts normally assign cases to three-judge panels. Twelve of the 16 5th Circuit judges who hear cases are Republican appointees.
The court could rule any time after briefs are due Wednesday afternoon.
Separately, the Biden administration on Wednesday proposed new privacy protections to prevent women’s health information from being used to investigate or sue people who obtain or facilitate abortions.
The abortion pill case is Alliance for Hippocratic Medicine et al v FDA et al, 5th U.S. Circuit Court of Appeals, No. 23-10362.
(Reporting by Jonathan Stempel and Brendan Pierson in New York, Editing by Alexia Garamfalvi, Bill Berkrot and Jonathan Oatis)
