The Kefauver-Harris Amendments 1962

Kefauver-Harris Amendments Revolutionized Drug Development

0135-President John F. Kennedy hands Sen. Estes Kefauver the pen

President John F. Kennedy hands Sen. Estes Kefauver the pen.

The 1962 Amendments to the Federal Food, Drug and Cosmetic (FD&C) Act. Commonly called the Kefauver-Harris Amendments, they were sponsored in Congress by Sen. Estes Kefauver (D-Tenn.) and Rep. Oren Harris (D-Ark.). Once signed into law by President Kennedy on Oct. 10, 1962, the amendments established a framework that required drug manufacturers to prove scientifically that a medication was not only safe, but effective.

“With the passage of the amendments, FDA was no longer a helpless bystander while unproven medicines were streaming into pharmacies and onto patients’ bedside tables,” says Hamburg.

After the thalidomide tragedy in Europe, US Congress passed the Kefauver-Harris drug amendments to ensure prescription drug effectiveness and safety. But the legislation may not have been proposed if not for the persistence and grit of a recently-hired FDA medical officer, and two U.S. congressmen.

Kefauver Harris Celebration

In response, on July 27, 1962, the FDA’s Bureau of Field Administration directed District Offices to find and remove from circulation all thalidomide stocks that were unaccounted for—by contacting each of the 1,200 plus physicians personally.

In fact, the situation was so dire and complex that when asked a question about thalidomide in his press conference on August 1, 1962, President Kennedy himself urged all women around the country to check the family medicine chest to make sure the drug was turned over to the FDA.