AAMC Files Supreme Court Amicus Brief on FDA Regulatory Authority

The AAMC filed an amicus brief in the Supreme Court in the case of U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, a case in which the court will consider a lower court’s opinion second-guessing the scientific judgement of the FDA and invalidating approval of the drug mifepristone.

The brief, which was submitted in support of the FDA, argues that the precedent set by allowing the ruling to stand would be not only unprecedented, but dangerous for patients and providers. “Permitting an individual court or judge to substitute his or her opinions for the FDA’s expert judgment threatens to upset this established, and highly successful, science-driven process and undermines the very authority Congress granted to the FDA,” the brief stated.

The AAMC’s brief also acknowledges the arguments of the FDA and several other amici asserting that the FDA properly exercised its authority in approving and setting the conditions for use of mifepristone, a drug that has been used safely and successfully for more than 20 years. 

The association previously issued an April 12, 2023, statement in response to the original actions from the U.S. District Court for the Northern District of Texas, noting that the opinion “specifically limits access to medication that is part of the full range of reproductive health care services. If allowed to remain in place, the court’s decision will increase the burden on historically and economically marginalized and disadvantaged populations, increase health inequities across the country, and ultimately put lives at risk.” The drug remains available pending the conclusion of the litigation and the case is scheduled for oral argument in the Supreme Court on March 26.