Health Care & Hospital Law,
Government
May 12, 2023
Mifepristone debate could jeopardize access to many other FDA-approved drugs
It is important to recognize the broad reach of the courts’ decisions in this case, the potential impacts of which are not limited to just the one drug at issue in the case. In fact, the district court’s reimagining of the Congressionally enacted and FDA-administered drug approval system has the potential to ripple across the drug development landscape.
On Nov. 18 the Alliance for Hippocratic Medicine and other organizations sued the U.S. Food and Drug Administration (FDA) seeking to overturn FDA's scientific determinations regarding the approvability of the mifepristone New Drug Application (NDA). Alliance for Hippocratic Medicine, et al. v. U.S. FDA, et al., No. 2:22-cv-00223. In an unprecedented decision, the Northern District of Texas granted plaintiffs' motion for a preliminary injunc...
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