Former FDA Officials Amicus Brief in Alliance for Hippocratic Medicine v. FDA

Amici are four former FDA officials who served in Republican and Democratic administrations.

The district court’s stay of FDA’s approval of mifepristone would return this country to its former piecemeal drug regulatory scheme—a scheme that Congress has already rejected. In response to previous public health crises resulting from looser regulation, Congress determined that a federal agency to approve drugs before they are marketed, composed of scientific and medical experts, is the best way to ensure access to safe and effective medication, and to protect public health. Substituting the determinations by FDA’s expert scientists, statisticians, and physicians’ of the safety and efficacy of a drug with determinations made by untrained federal judges would lead to catastrophic consequences, including depriving patients of life-saving medication.

This brief was one of many filed in support of the FDA in Alliance for Hippocratic Medicine v. FDA. For more information on the case, click here.