On Jun. 20, 1963, the FDA announced three sets of regulations governing“ the manufacture, effectiveness and promotion of drugs. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them.

The Kefauver-Harris Amendments, sponsored by Senator Estes Kefauver, of Tennessee, and Representative Oren Harris, of Arkansas, strengthened the FDA’s authority over prescription drugs in several important ways, and the agency continues to enforce these provisions today.