Mifepristone

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Last year Bexis was lead author on a law review article in the Food and Drug Law Journal titled Federal Preemption and the Post-Dobbs Reproductive Freedom Frontier.  The article expands on themes previously raised in this blog, including here, here and here.  It discusses the application of federal preemption under the Food Drug and Cosmetic Act (FDCA) to state-law medication abortion restrictions after Dobbs. The article recognized that, following Dobbs, it was inevitable that FDCA preemption would become embroiled in the abortion controversy. That prediction was accurate.  Today’s decision addresses the impact of preemption on a North Carolina law that imposed significant restrictions on an FDA approved medication taken to terminate a pregnancy.Continue Reading North Carolina and Post-Dobbs Regulation of Mifepristone

Photo of Lisa Baird

We have posted a few times (here, here, and here) about the Alliance for Hippocratic Medicine v. FDA/Alliance for Hippocratic Medicine v. Danco Labs., LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone, a pharmaceutical FDA-approved for use…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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