Two judges—one in Texas, and one in Washington—issued competing rulings on the fate of the abortion medication mifepristone on Friday, throwing the future of access to the pill into question.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on the federal approval of mifepristone, in what multiple publications have said overruled decades of scientific approval. His 67-page order gave the government seven days to appeal. This ruling came at almost the same time as another ruling issued by a judge in Washington state.
U.S. District Judge Thomas O. Rice, an Obama appointee, issued a ruling basically doing the exact opposite of Kacsmaryk shortly after. His ruling ordered U.S. authorities to not make any changes that would restrict access to mifepristone in 17 Democratic-led states that sued in an effort to protect availability.
Mifepristone is the most commonly-used method of abortion in the United States, and as of right now, there is essentially no precedent for a judge overruling medical decisions made by the FDA, according to the Associated Press. The drug, along with misoprostol, are usually prescribed in conjunction to end a pregnancy.
Both health clinics and doctors have said that if mifepristone is pulled from the market, they’ll be forced to prescribe just misoprostol, which has a lower rate of effectiveness. Legal experts have said that this ruling could “upend decades of precedent” and could “set the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.”
“This has never happened before in history — it’s a huge deal,” Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School told the Associated Press. “You have a federal judge who has zero scientific background second guessing every scientific decision that the FDA made.”
The Biden administration has said that it will fight the Texas ruling.
“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden said in a statement issued Friday. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
As the Associated Press notes, these conflicting decisions put the issue on “an accelerated path” to the Supreme Court, and of course, they come nearly a year after the court overturned Roe v. Wade, the landmark case that ruled that the Constitution protected access to abortion. In fact, the Texas lawsuit was filed by the Alliance Defending Freedom, a conservative, Christian legal advocacy group, that was involved in the Mississippi case that led to Roe v. Wade being overturned.
Whole Women’s Health, which operates six abortion clinics in five states, slammed the decision, saying that it would continue to dispense mifepristone in person and by mail over the next week as the rulings are reviewed.
Over 300 biotech and pharmaceutical industry executives, including Pfizer Inc. CEO Albert Bourla, signed an open letter on Monday calling for the reversal of Kacsmaryk’s decision.
“We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place,” they wrote.
They went on to say that the decision “puts the entire industry at risk” and “sets a precedent for undermining the agency’s authority to approve drugs.” They added that the decision lends itself to “regulatory uncertainty” that they warned would “disincentivize investment in new treatments.”
Ovid Therapeutics CEO Jeremy Levin told Reuters that the ruling could “open the possibility to the banning of vaccines and contraception for women.”
“This is a nightmare scenario for the industry,” he said. “It’s the single worst threat to the industry in over 50 years.”
The Justice Department has also asked a federal appeals court to put a hold on the Texas ruling as of Monday.
by Isabel Soisson
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