South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What legislation, established in 1962, provides additional drug effectiveness requirements?

1. Kefauver-Harris Amendment

2. Prescription Drug Marketing Act

3. FDA Modernization Act

4. Orphan Drug Act

The correct answer is: Kefauver-Harris Amendment

The Kefauver-Harris Amendment, established in 1962, significantly altered the landscape of drug approval in the United States by introducing additional requirements focused on the effectiveness of medications. Prior to this amendment, the regulatory framework primarily emphasized safety without necessitating demonstration of a drug's efficacy. With the passing of the Kefauver-Harris Amendment, it became mandatory for drug manufacturers to provide substantial evidence that their products not only are safe for consumption but also effective for their intended uses. This shift was largely influenced by the thalidomide tragedy, where a drug that was safe when taken by pregnant women led to serious birth defects, highlighting the crucial need for both safety and effectiveness in pharmaceuticals. This legislation also strengthened the FDA's authority to regulate prescription drug advertising and required that clinical trial information be reported to the FDA. The legislation introduced a more robust framework for drug testing, leading to improved public health outcomes since only those drugs that meet both safety and efficacy standards could be marketed. Overall, this amendment marked a pivotal moment in drug regulation, emphasizing the necessity for rigorous scientific evidence before a drug could gain market approval, and is a cornerstone of modern pharmaceutical regulations.