What is a key focus of the Kefauver-Harris amendment?

The Kefauver-Harris Amendment, which was enacted in 1962, primarily emphasizes the importance of establishing both the safety and efficacy of pharmaceuticals before they can be approved for the market. This legislation was a response to concerns about the thalidomide tragedy, where an unsafe drug led to serious birth defects. Therefore, the amendment strengthened the regulatory framework administered by the Food and Drug Administration (FDA) by requiring that manufacturers provide substantial evidence showing that their drugs are not only safe for consumption but also effective in treating the conditions they are advertised for.

While other options address important topics in the realm of pharmaceuticals and public health, such as labeling for over-the-counter drugs, regulating dietary supplements, and controlling drug prices, they do not directly relate to the core objective of the Kefauver-Harris Amendment. This amendment was significant in shifting the focus of drug approval processes to include both safety and therapeutic effectiveness, paving the way for more stringent oversight of pharmaceutical products. Hence, the correct answer reflects the amendment's foundational role in ensuring that any drug marketed in the United States meets essential safety and effectiveness standards.