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

The Kefauver Harris Amendment, enacted in 1962, was a significant piece of legislation that aimed to strengthen the regulations governing the approval of new drugs. One of its primary objectives was to ensure that drugs not only be safe but also effective before they could be marketed to the public. This meant that pharmaceutical companies were required to conduct efficacy trials demonstrating that their products could deliver the claimed benefits.

The amendment was a response to past public health crises, particularly following the thalidomide tragedy, where a drug caused severe birth defects due to lack of efficacy requirements. By mandating efficacy trials, the amendment aimed to protect patients from ineffective medications and ensure that they had access only to products that were not only safe but also effective in treating their intended conditions. This move shifted the landscape of drug regulation, placing significant focus on clinical trials and the evaluation of therapeutic benefits.

The other options do not align with the primary intent of the Kefauver Harris Amendment. While proper labeling is important and the amendment does enforce labeling requirements, its main thrust was efficacy. Off-label drug usage is not prohibited under this amendment; instead, it is generally allowed but comes with specific regulations. Lastly, pricing guidelines for pharmaceuticals were not part of the scope of this amendment, which