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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