What does the Kefauver Harris Amendment require from manufacturers?

The Kefauver Harris Amendment, enacted in 1962, fundamentally changed the regulatory requirements for drug approval in the United States. Prior to this amendment, manufacturers were only required to demonstrate that their drugs were safe. However, the Kefauver Harris Amendment introduced the expectation that manufacturers must provide proof of both the safety and efficacy of their drugs before they can be approved for marketing.

This comprehensive requirement ensures that the drugs not only do not cause harm but also effectively treat the conditions they are intended to address. The rationale behind this amendment was to enhance consumer protection, particularly in the wake of public health crises caused by unsafe or ineffective pharmaceuticals, such as the thalidomide tragedy.

Given this context, the correct answer reflects the dual obligation placed on manufacturers to demonstrate that their products are both safe for consumption and effective for their intended use, aligning with the regulatory advances meant to enhance patient safety and therapeutic outcomes.