Analysis: Texas abortion pill ruling could undermine US drug regulator

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A federal judge's decision last week to suspend the U.S. Food and Drug Administration's (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said.

, which followed a March 15 hearing, was a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues in the Northern District of Texas.

Some said it could also lead drugmakers to stick to treatments perceived as safe investments and shy away from those that might get caught up in politically charged legal cases. Any impact on the FDA will depend on details of the judge's final ruling on the merits of the challenge in the case known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

"That would have much bigger implications for other drugs and probably would shake up pharma's ability to rely on the FDA and feel secure when they submit something, if a court can overrule the FDA's findings on safety," said Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation.

U.S Health Secretary Xavier Becerra told CNN on Sunday the court's decision on Friday was reckless and warned it would have far reaching ramifications.Even if Kacsmaryk does not address safety and bans mifepristone after finding that the FDA did not follow proper procedures, that would still undermine confidence in the agency.

"There's going to be so much uncertainty about what would happen even if you were to achieve approval in the first place," said Lee. "There could be a downstream impact on pricing."

 

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It's getting to the point where conservative judges are legislating and making scientific decisions.

Oh No!! How will Big Pharma and the Federal Government survive?

You mean the same drug regulator that approved the deadly covid jab, Vioxx, and Thalidomide?

'a ruling against the FDA's approval of a drug over 20 years earlier is unprecedented and - if it stands after going through the appeals process - could ripple through drug research and development for years, with implications for public health and access to new treatments.'

Texans have already screwed up their state, now they’re trying to drag the rest of us down to their level. Secede already.

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Supreme Court likely to have final say over abortion pill mifepristone, expert saysFor now, the drug that the Food and Drug Administration approved in 2000 remains at least immediately available in wake of the separate rulings by judges in Texas and Washington state.
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Reaction to Texas Abortion Pill Ruling: Outrage, and Muted PraiseAs Americans digested a Texas judge’s ruling on Friday night invalidating the Food and Drug Administration’s approval of the abortion drug mifepristone — and a contradictory ruling from a judge in Washington state ordering the FDA to maintain its approval as is in some states — the divide in political reactions was as much between words and silence as it was between pro- and anti-abortion rights. National Democratic officials reacted with a torrent of statements condemning the Texas judge, Matth
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