by Andrew L. Bab, Maura Kathleen Monaghan, Paul D. Rubin, Shannon Rose Selden, Kim T. Le, Jacob W. Stahl, Adam Aukland-Peck, Prakriti Luthra, Melissa Runsten, and Charlotte Blatt
From top left to right: Andrew L. Bab, Maura Kathleen Monaghan, Paul D. Rubin, Shannon Rose Selden, and Kim T. Le.
From bottom left to right: Jacob W. Stahl, Adam Aukland-Peck, Prakriti Luthra, Melissa Runsten, and Charlotte Blatt. (Photos courtesy of Debevoise & Plimpton LLP)
On November 18, 2022, the Alliance for Hippocratic Medicine and several other plaintiffs (“Plaintiffs”) filed suit in federal court against the Food and Drug Administration (the “FDA”), seeking to overturn the FDA’s approval of mifepristone, a drug commonly used for medication abortions, as well as in the management of miscarriage and in the treatment of certain diseases (the “AHM Litigation”). After expedited briefing and a hearing, Northern District of Texas Judge Matthew Kacsmaryk issued a preliminary order that would effectively remove mifepristone from the market nationwide for use in the termination of pregnancy. The court signaled its belief that both the FDA’s initial approval and its subsequent decision to eliminate certain restrictions on its use were arbitrary and capricious because the FDA had allegedly failed to consider relevant safety data.
While the merits of this case have yet to be fully litigated—and the Supreme Court has temporarily preserved the status quo—this case may have significant implications for the broader healthcare industry, including FDA-regulated entities as well as providers, insurers, and even companies that subsidize healthcare for their employees.