08-04-2023, 06:14 PM
By PAUL J. WEBER, MATTHEW PERRONE and LINDSAY WHITEHURST
today
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U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision came at nearly the same time that U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordered the opposite and directed U.S. authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability.
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The whiplash of the conflicting decisions is likely to put the issue on an accelerated path to the Supreme Court.
“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.
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The abortion drug has been widely used in the U.S. since securing FDA approval and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration.
......
Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.
......
Legal experts warned that the ruling could upend decades of precedent, setting 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,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School. “You have a federal judge who has zero scientific background second guessing every scientific decision that the FDA made.”
https://apnews.com/article/abortion-pill...6151bc86ef
today
......
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision came at nearly the same time that U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordered the opposite and directed U.S. authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability.
......
The whiplash of the conflicting decisions is likely to put the issue on an accelerated path to the Supreme Court.
“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.
......
The abortion drug has been widely used in the U.S. since securing FDA approval and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration.
......
Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.
......
Legal experts warned that the ruling could upend decades of precedent, setting 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,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School. “You have a federal judge who has zero scientific background second guessing every scientific decision that the FDA made.”
https://apnews.com/article/abortion-pill...6151bc86ef