What law regulates the marketing of prescription drugs to ensure safety and efficacy?

The Kefauver Harris Amendment is indeed the law that specifically regulates the marketing of prescription drugs to ensure their safety and efficacy. Enacted in 1962, this amendment to the Federal Food, Drug, and Cosmetic Act requires that drug manufacturers provide substantial evidence of a drug's effectiveness before it can be approved for sale to the public. This legislation emerged as a response to the thalidomide tragedy, where inadequate regulations allowed a drug to be marketed without sufficient efficacy testing, leading to severe birth defects.

The Kefauver Harris Amendment also enhanced reporting requirements for adverse drug reactions and required that drug advertising be truthful and not misleading. By mandating these provisions, it marked a significant shift in the regulatory landscape for pharmaceuticals, emphasizing the need for both safety and therapeutic effectiveness in the marketing of prescription medications.

In contrast, the Federal Food, Drug, and Cosmetic Act laid the groundwork for drug regulation but did not specifically address the requirement for efficacy. The Controlled Substances Act is primarily concerned with the regulation of narcotics and drugs that have a potential for abuse. The Durham Humphrey Amendment focuses on the distinction between prescription and over-the-counter medications, allowing refills for prescription medications but does not tackle the efficacy concerns directly. Thus, the Kefauver Harris