Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

What did the Kefauver-Harris Drug Amendment of 1962 require for all marketed drugs?

1. Approval from the importer

2. Evidence of safety and efficacy

3. Only efficacy data

4. Special import licenses

The correct answer is: Approval from the importer

The Kefauver-Harris Drug Amendment of 1962 fundamentally changed the regulatory landscape for pharmaceuticals in the United States by requiring manufacturers to provide substantial evidence of both safety and efficacy for their products before they could be marketed. This was a significant shift from prior regulations, which primarily focused on the safety of drugs. The requirement for evidence of safety and efficacy means that pharmaceutical companies must conduct clinical trials and submit data to prove that their drugs are not only safe for use but also effective in treating their intended conditions. This Amendment was largely a response to the thalidomide tragedy, where a drug caused severe birth defects when it was used by pregnant women, highlighting the need for more stringent regulatory standards in the drug approval process. In this context, the correct choice clearly emphasizes the necessity of comprehensive evidence for drugs in the marketplace. The other options do not reflect the core requirement established by the Amendment, which was that both safety and efficacy must be demonstrated before a drug could be approved for use.