What is one of the key purposes of the Kefauver Harris Amendment?

The Kefauver Harris Amendment, enacted in 1962, was primarily aimed at ensuring that medications not only be safe but also effective prior to their approval for public use. One of its key provisions was the requirement that manufacturers demonstrate the efficacy of their drugs through rigorous clinical trials before receiving approval from the Food and Drug Administration (FDA). This represented a significant shift from the earlier regulations that only required safety testing, thereby placing a stronger emphasis on both safety and effectiveness in the drug approval process.

This amendment came in response to public health crises, such as the thalidomide tragedy, where a drug was found to cause severe birth defects despite being marketed as safe. As a result, the requirement for efficacy trials was established to protect consumers and ensure that only drugs with proven therapeutic benefits are made available.

The other options do not align with the primary goals of the Kefauver Harris Amendment. For instance, while proper labeling is important for dietary supplements, that aspect pertains more to other regulations like the Dietary Supplement Health and Education Act. Moreover, off-label usage of medications, which refers to prescribing drugs for unapproved conditions, is not directly addressed by this amendment. Finally, establishing pricing guidelines for pharmaceuticals is outside the scope of this legislative act, which focused