Discussion: The Role, Position, and Function of the FDA—The Past, Present, and Future

Abstract

The health of the nation and the world has been profoundly positively influenced by the pursuit and implementation of evidence-based approaches for the prevention and treatment of diseases. The US Food and Drug Administration (FDA), along with other regulatory authorities throughout the world, have made critically important contributions to this pursuit. The FDA recognizes their mission is to be “responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation... FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.” The FDA has effectively addressed their mission by providing consistently strong leadership and oversight that has been of integral importance to protecting public health. The FDA has been highly influential in the attainment of substantial evidence of efficacy and safety of approved drugs, biologics and devices by ensuring achievement of proper standards for design, conduct and analysis of registrational trials. Among these significant favorable influences have been: ∼ Encouraging stepwise clinical development; ∼ Having pro…