FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

The Kefauver-Harris Amendment, enacted in 1962, introduced significant changes to the way drugs were regulated in the United States. This amendment specifically requires drug manufacturers to provide evidence of safety and efficacy for their products before they can be marketed. This requirement arose in response to concerns about the safety of drugs, particularly after the thalidomide tragedy, which highlighted the potential risks associated with medications that had not been thoroughly tested. The emphasis on proving both safety and efficacy means that manufacturers must conduct rigorous clinical trials and provide comprehensive data supporting their claims. This regulatory framework helps ensure that only drugs with a demonstrated positive benefit-risk balance can enter the market, thereby protecting public health. Factors such as manufacturing processes, price competitiveness, and market demand, while important in the context of drug development and commercialization, are not mandated by the Kefauver-Harris Amendment. Thus, the correct answer reflects the fundamental essence of this legislation, which is centered around the necessity for demonstrated safety and efficacy of pharmaceuticals.