Celebrating a Public Health Milestone: The Kefauver-Harris Drug Amendments

By: Margaret Hamburg, M.D.

Margaret Hamburg, M.D.My predecessor, FDA Commissioner George Larrick, once said that, with the exception of 1906 and 1938, no date had more significance in the agency’s history than October 10, 1962, when President Kennedy signed into law the Kefauver-Harris Drug Amendments.  Commissioner Larrick stood behind the President at that momentous event.

The amendments were the response by Congress to the birth of thousands of malformed children, in Europe and elsewhere, whose mothers had used thalidomide during pregnancy.  The U.S. was spared that tragedy, thanks to the vigilance of FDA’s Dr. Frances Kelsey.

Fountain pen enscribed "The President - The White House"

With this pen, which he presented to Dr. Frances Kelsey, President John Kennedy signed into law the 1962 Kefauver-Harris Drug Amendments.

The time was therefore ripe for reform to protect and to promote public health, and it came in the form of legislation proposed by Sen. Estes Kefauver.  The Drug Amendments of 1962 strengthened the Federal Food, Drug and Cosmetic Act by requiring solid and rigorous science-based evidence that drugs are both effective and safe and in doing so the law laid the foundation for today’s modern pharmaceutical industry. 

To comply with the new amendments, manufacturers were now required to test their drugs in a truly scientific manner — typically, by conducting two well-designed and controlled clinical trials.  Companies also had to adhere to good manufacturing practices and monitor safety reports after the drugs reached the market.

With the benefit of hindsight, we can now see that the Drug Amendments of 1962 did much more than strengthen FDA’s authorities to ensure that our medications are safe and effective. The requirements of this law have since then been adopted world-wide, and became the “gold standard” for science-based decisions involving drugs.

In short, the Drug Amendments of 1962 merit our great praise on their fiftieth anniversary: they have saved countless lives around the world.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration