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Abortion opponents have urged a US appeals court to allow the suspension of Food and Drug Administration’s approval of the abortion pill mifepristone, in a case with potentially far-reaching impact on how the government regulates medicine.
In a filing with the 5th US Circuit Court of Appeals in New Orleans on Tuesday, 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 abortion opponents’ requests came one day after the US Department of Justice urged the appeals court to put District Judge Matthew Kacsmaryk’s April 7th order voiding the FDA’s approval on hold through the appeals process.
Judge Kacsmaryk, a Texas judge appointed by former Republican president Donald Trump, had issued only a seven-day stay.
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The groups and doctors are led by the Alliance for Hippocratic Medicine, which was formed last August. It is not clear when the 5th Circuit will 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 US 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 Judge 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 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.
Twenty-three mostly Democratic-led states plus Washington, DC, 28 municipalities including Baltimore, Boston and Los Angeles, and most Democratic members of Congress filed briefs supporting a longer stay of the decision.
Many others backed the decision, including 69 Republican members of Congress who said the FDA's actions posed "grave risks" to women and girls seeking "chemical abortions," a term the judge also used.
Judge Kacsmaryk, based in Amarillo, 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 that directed the FDA to keep the drug available in 17 states and Washington, DC.
If the split persists, the US Supreme Court may be asked to resolve the matter.
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