What did the Kefauver-Harris Amendment of 1962 require for medications in the U.S.?

The Kefauver-Harris Amendment of 1962 was a significant piece of legislation that emerged as a response to the thalidomide tragedy, which raised public concern about the safety and efficacy of medications. This amendment established that all medications marketed in the United States must be proven to be pure, safe, and effective before they can be approved by the FDA.

This requirement marked a pivotal shift in drug regulation, emphasizing not only the safety of medications but also their efficacy, which means that manufacturers must provide substantial evidence that their drugs have the intended benefits before regulatory approval. This was a massive enhancement over previous standards, which only required that a drug be safe for use, driving home the critical importance of evidence-based medicine in ensuring public health.

The other options, while they contain elements of drug regulations, do not directly relate to the core requirements established by the Kefauver-Harris Amendment. For instance, childproof packaging, prescriptions provided by licensed pharmacists, and accurate labeling are important aspects of drug safety and practice but were not the primary focus of this specific amendment. Thus, the requirement for all medications to be proven pure, safe, and effective accurately reflects the key impact of the Kefauver-Harris Amendment on drug regulation in the United