Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

Which of the following was a result of the Kefauver-Harris Amendment of 1962?

1. Allowed ANDA for generics

2. Established the FDA

3. Required adverse reaction reporting

4. Separated prescription and OTC drugs

The correct answer is: Allowed ANDA for generics

The correct answer is A. The Kefauver-Harris Amendment of 1962 was a significant piece of legislation that strengthened the requirements for drug approval in the United States. Specifically, it required drug manufacturers to provide scientific evidence of a drug's effectiveness and safety before it could be approved for marketing in the country. Additionally, it mandated that generic drug manufacturers submit an Abbreviated New Drug Application (ANDA) demonstrating bioequivalence to the brand-name drug. This requirement helped pave the way for the approval process of generic medications and increased access to more affordable alternatives for patients. Options B, C, and D are incorrect: B. Established the FDA - The FDA (Food and Drug Administration) was actually established in 1906 with the passage of the Pure Food and Drug Act. The Kefauver-Harris Amendment of 1962 did not establish the FDA. C. Required adverse reaction reporting - While the Kefauver-Harris Amendment did enhance drug safety regulations, including requirements for drug effectiveness and safety, the specific mandate for adverse reaction reporting was not a direct result of this amendment. D. Separated prescription and OTC drugs - The separation of prescription and over-the-counter (OTC) drugs is not a direct result of the Kefauver-Harris Amendment of 1962. This amendment mainly focused on drug approval processes and requirements for manufacturers.