"Fraud on FDA"

Executive Summary

Supreme Court finds state law claims based on "fraud on FDA" in device premarket submissions could have adverse consequences on the regulatory balance. The Feb. 21 decision in favor of Buckman Company reverses a lower court ruling in Buckman v. Plaintiffs Legal Committee. The Pharmaceutical Research & Manufacturers of America filed an amicus brief in support of Buckman arguing that the lower court's decision, unless reversed, would improperly permit states to second-guess FDA approval decisions (1"The Pink Sheet" Dec. 11, 2000, p. 15)