Alliance for Hippocratic Medicine v. FDA — Dobbs’s Collateral Consequences for Pharmaceutical Regulation

This Perspective analyzes the legal and public health implications of Alliance for Hippocratic Medicine v. FDA, a lawsuit challenging the FDA’s approval of mifepristone (used in medication abortion) under the Dobbs decision’s aftermath. The authors argue that the plaintiffs’ claim that pregnancy is not a "serious or life threatening illness" justifying mifepristone’s approval misreads the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA regulations, which interchangeably use "illness," "disease," and "condition." They highlight risks to FDA authority and pharmaceutical innovation if courts disregard statutory frameworks. The article warns against "abortion exceptionalism" in judicial rulings and underscores broader consequences for drug regulation beyond reproductive health.

This Perspective analyzes the legal and public health implications of Alliance for Hippocratic Medicine v. FDA, a lawsuit challenging the FDA’s approval of mifepristone (used in medication abortion) under the Dobbs decision’s aftermath. The authors argue that the plaintiffs’ claim that pregnancy is not a "serious or life threatening illness" justifying mifepristone’s approval misreads the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA regulations, which interchangeably use "illness," "disease," and "condition." They highlight risks to FDA authority and pharmaceutical innovation if courts disregard statutory frameworks. The article warns against "abortion exceptionalism" in judicial rulings and underscores broader consequences for drug regulation beyond reproductive health.