What does the Kefauver-Harris Amendment primarily address?

The Kefauver-Harris Amendment, enacted in 1962, primarily addresses drug effectiveness. This legislation was a response to public outcry following the thalidomide tragedy, where a drug that was marketed as safe for pregnant women led to severe birth defects. As a result, this amendment required that drug manufacturers not only prove the safety of their drugs but also demonstrate their effectiveness before receiving approval from the Food and Drug Administration (FDA).

This dual requirement emphasized the need for rigorous testing and substantial evidence to confirm that a drug can provide the intended therapeutic effect, thus ensuring that patients would receive medications that are both safe and effective. The amendment significantly strengthened FDA's authority over pharmaceutical products and laid the groundwork for the modern drug approval process. This focus on drug effectiveness ensures that patients are not only protected from unsafe drugs but also from those that do not provide the health benefits they claim.