Which law established standards for drug effectiveness?

The Kefauver-Harris Amendment is the correct answer because it was enacted in response to concerns about the safety and effectiveness of drugs after the thalidomide tragedy in the 1960s. This amendment required that pharmaceutical manufacturers provide evidence of the effectiveness and safety of their drugs before they could be approved for market by the FDA. It heightened the standards for drug efficacy and mandated stricter regulations, ensuring that new drugs had to demonstrate tangible benefits over existing treatments, thereby protecting consumers from ineffective medications.

In contrast, the Pure Food and Drug Act primarily focused on preventing the sale of adulterated or misbranded products and did not impose standards for drug effectiveness. The Drug Enforcement Administration Act relates to the regulation and enforcement of controlled substances rather than drug effectiveness. The Food Quality Protection Act addresses pesticide residues in food but does not pertain to drug standards. Thus, the Kefauver-Harris Amendment is pivotal in establishing rigorous standards for drug effectiveness in the pharmaceutical industry.