In an order signed by Justice Samuel Alito, the court asked both sides to weigh in by Tuesday over whether lower court rulings restricting the Food and Drug Administration’s approval of the drug, mifepristone, should be allowed to take effect while the case works its way through federal courts. The order suggests the court will decide that issue by late Wednesday.
The Justice Department and Danco Laboratories both warned of “regulatory chaos” and harm to women if the high court doesn’t block an appeals court ruling in a case from Texas that had the effect of tightening Food and Drug Administration rules under which the drug, mifepristone, can be prescribed and dispensed.
The Biden administration and Danco, which is based in New York, also want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.
“To the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years,” Prelogar wrote. Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market.
But the judges suggested FDA changes making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be “difficult” to argue the changes were “so critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for sixteen years” the judges wrote.
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