West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Which law required for the first time that manufacturers prove to the FDA that a drug is both safe and effective for the claims made in the product's labeling, and created the NDA and sNDA?

1. Controlled Substances Act

2. Durham-Humphrey Amendment of 1951

3. Kefauver-Harris Amendment of 1962

4. Pure Food and Drug Act of 1906

The correct answer is: Kefauver-Harris Amendment of 1962

The Kefauver-Harris Amendment of 1962 was a pivotal law in the history of pharmaceutical regulation in the United States because it established the requirement for drug manufacturers to provide evidence to the FDA demonstrating not only the safety of a drug but also its effectiveness for the specific claims made on its labeling. This amendment arose in response to concerns about the thalidomide tragedy, which highlighted the need for stricter regulation of pharmaceuticals. By introducing the New Drug Application (NDA) and the shortened New Drug Application (sNDA) processes, the Kefauver-Harris Amendment ensured that all new drugs would undergo a rigorous review process before being marketed. The NDA requires comprehensive data on a drug's safety, efficacy, and manufacturing quality, while the sNDA allows for modifications to approved applications, such as new indications or changes in labeling. Understanding the significance of this amendment is crucial for pharmacy professionals, as it laid the foundation for current regulatory requirements regarding drug approval in the United States, emphasizing both safety and efficacy as key components in the evaluation process.