This brief was filed on behalf of dozens of pharmaceutical companies, pharmaceutical company executives, and industry investors from across the United States.
The brief emphasizes that Congress intended the FDA, not courts, to serve as the expert arbiter of drug safety and effectiveness and the FDA’s drug approval process is the gold standard of review. Further, the brief states that the district court improperly substituted its own views for FDA’s expert scientific judgement, the district court’s decision would create impossibly rigid new standards for drug development and approval, and the district court’s transformation of these requirements would chill drug development and investment.
This brief was one of many filed in Alliance for Hippocratic Medicine v. FDA. For more information on the case, click here.