Which amendment requires drug manufacturers to prove a drug is both safe and effective?

The Kefauver-Harris Amendment, enacted in 1962, is the legislation that requires drug manufacturers to demonstrate that a drug is both safe and effective before it can be marketed to the public. This amendment was a response to the thalidomide tragedy, where a medication caused severe birth defects. Prior to this amendment, the focus was primarily on safety, but the evidence of thalidomide’s devastating effects highlighted the need for a more rigorous standard that included efficacy as well.

The Kefauver-Harris Amendment introduced new requirements for drug approval that mandated clinical trials to prove a drug’s effectiveness. This shift significantly strengthened the FDA's authority and oversight over the pharmaceutical industry, ensuring that patients receive medications that undergo comprehensive evaluations for both safety and effectiveness.

Other legislative options, like the Pure Food and Drug Act and the Food, Drug, and Cosmetic Act, primarily focused on ensuring the safety and labeling of food and drugs, but did not specifically require the proof of efficacy from manufacturers. The Humphrey-Hawkins Amendment also pertains to regulations around prescription medications but does not introduce the requirement for proving effectiveness.