What did the Kefauver-Harris Amendment of 1962 ensure regarding drug safety?

The Kefauver-Harris Amendment of 1962 was a significant piece of legislation in the United States that mandated that all drugs marketed had to be proven safe and effective for their intended use before they could be sold to the public. This amendment was a response to the thalidomide tragedy, where a sedative caused severe birth defects when taken by pregnant women. The legislation reinforced the requirement that pharmaceutical companies had to provide substantial evidence of efficacy as well as safety through rigorous testing and clinical trials.

This focus on ensuring both safety and effectiveness represented a major shift in the regulatory landscape for pharmaceuticals and helped to safeguard public health by making sure that only drugs that met these standards could be approved for use. The requirement helped to build greater consumer trust in the medications available on the market and ensured that patients received treatments that were not only safe but also effective in addressing their medical conditions.