, the Fifth Circuit Court said it put the plaintiffs challenge to the 2000 approval on hold because too much time had passed, but ruled that Kacsmaryk’s decision to undo the FDA’s more recent changes that began in 2016—which extended the drug’s use into 10 weeks of pregnancy, and allowed it to be delivered to patients by mail—could remain in place. The court has put those measures on hold.
The implications of this ruling could be far-reaching; Democrats and the drug makers have warned it could undercut how the country regulates medications all together. “First and foremost, when you turn upside down the entire FDA approval process, you’re not talking about just mifepristone,” Health and Human Services secretaryon CNN. “You’re talking about every kind of drug.
The mifepristone fight is not over. The appeals court still has to decide on the case, and the issue is expected to be escalated to the Supreme Court.
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