What does the Kefauver-Harris Amendment (1962) mandate for new drugs before they can be marketed?

The Kefauver-Harris Amendment, enacted in 1962 as part of the Federal Food, Drug, and Cosmetic Act, introduced significant changes to the regulation of pharmaceuticals in the United States. This amendment specifically required that new drugs not only be safe but also proven effective for their intended use before they could be marketed. This was a pivotal moment in drug regulation, as it shifted the focus from merely ensuring the safety of drugs to also establishing their efficacy.

The mandate for proving efficacy meant that drug manufacturers had to conduct rigorous clinical trials and submit comprehensive data demonstrating that their products provided the claimed therapeutic benefits. This requirement aimed to protect consumers from ineffective or potentially harmful medications and implemented a higher standard for drug approval.

While other aspects, such as FDA approval for advertising, compliance with state laws, and obtaining a patent, are important considerations in the pharmaceutical landscape, they are not directly addressed by the Kefauver-Harris Amendment. The primary focus of the amendment was to ensure that new drugs met stringent criteria for effectiveness and safety.