Suit To Scrap Abortion Drug Cites Accelerated Approval Policy, PREA

By Beth Wang / November 23, 2022 at 12:06 PM
Four anti-abortion medical groups filed suit against FDA, alleging the agency more than 20 years ago illegally approved medication abortion, which comprises mifepristone and misoprostol, in violation of pediatric research law and the agency’s accelerated approval pathway, and the groups are urging a U.S. district court in Texas to force FDA to withdraw approval of the brand and generic versions, marking a first-of-its-kind lawsuit challenging FDA’s approval of the abortion pill. The lawsuit was filed by conservative Christian legal advocacy...

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