Brief of Professors of Law, Medicine, and Public Health in Vanda v. United States

Vanda mischaracterizes Ruckelshaus v. Monsanto by treating it as establishing a per se taking whenever FDA uses or discloses trade secret information, when in fact Monsanto requires a statutory promise of secrecy, absent from the Food, Drug, & Cosmetic Act, for any such takings claim to succeed. The amici warn that accepting Vanda’s broad interpretation would obstruct generic drug competition under Hatch-Waxman and chill FDA’s ability to communicate essential public health information such as adverse event data, manufacturing inspection reports, clinical trial protocols, and drug shortage information.