The Harris-Kefauver Amendments required which standard for drug approval?

• A. Scientific proof of efficacy
• B. Scientific proof of safety
• C. Created two classes of products
• D. Prohibits false claims for drug products

Answer: (A)

The key idea is that these amendments require proof of a drug’s effectiveness before it can be approved. After the Thalidomide tragedy, the FDA shifted from approving drugs based on safety alone to demanding substantial evidence that a drug actually works for its claimed use. This means data from adequate and well-controlled studies showing that the drug has the intended effect, not just that it is safe. The other options don’t capture this testing standard: safety alone was not enough, the amendments didn’t create two product classes for this purpose, and prohibiting false claims concerns advertising and labeling rather than the approval standard itself.