Evolution of FDA Regulations and Impact on Drug Approvals

This chapter explores the transformation of the Food and Drug Administration, particularly through the heroic actions of FDA reviewer Dr. Frances Kelsey during the thalidomide crisis in the late 1950s. It also delves into how the introduction of prescription drug user fees in the 1990s expedited pharmaceutical approvals but raised concerns about conflicts of interest. The chapter also discusses the influence of funding sources on drug approval outcomes and proposes radical solutions to address the impact of pharmaceutical corporations on medical testing and trust in doctors.