Assessing the Legal Claims in Alliance for Hippocratic Medicine v. FDA
Last fall, the Alliance for Hippocratic Medicine (AHM) filed a lawsuit against the U.S. Food and Drug Administration seeking to force a revocation of the FDA’s approval of mifepristone, a drug that is widely prescribed to terminate pregnancies (i.e. to perform a “medication abortion”).
This lawsuit has generated substantial commentary, but very little legal analysis. Articles warn that a single federal judge in Texas could ban a common abortion drug, and cast all sorts of aspersions on that judge before he has issued a single ruling in the case, but few identify, let alone discuss, the legal questions that will determine the outcome of the case. Like most legal controversies touching abortion, everyone knows what side they are supposed to be one given their views of the underlying subject matter, and few have stopped to consider what the law has to say about how this case should be resolved.
As most of the underlying legal issues in AHM v. FDA concern administrative law—and have nothing directly to do with whether the FDA properly approved mifepristone, let alone whether abortifacient drugs should be available, I figured it was worth taking a deep dive into the case. Fortunately, Adam Unikowsky, a former Scalia clerk who is now a partner at Jenner & Block, has already done such a dive.
Unikowsky has a post on substack, “Mifepristone and the Rule of Law,” analyzing AHM’s claims. Here is how it begins:
In 2000, the FDA approved a drug known as mifepristone for purposes of terminating pregnancies through 49 days’ gestation. The FDA concluded that mifepristone, when used in conjunction with a different drug called misoprostol, was safe and effective, and that the benefits of mifepristone exceeded the risks.
In November 2022, a group of plaintiffs, led by the Alliance for Hippocratic Medicine, filed a federal lawsuit in the Northern District of Texas seeking to overturn the FDA’s approval of mifepristone and force mifepristone off the market. The plaintiffs have filed a motion for a preliminary injunction, which is currently pending in the district court.
This lawsuit has gotten considerable attention from the press. Many
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