Regulatory Focus™ > News Articles > FDA Marks Half-Century of Regulation Based on Safety, Efficacy

FDA Marks Half-Century of Regulation Based on Safety, Efficacy

Posted 10 October 2012 | By Alexander Gaffney, RAC 

A half-century ago today, the US Food and Drug Administration (FDA) experienced perhaps its greatest expansion of regulatory authority since its inception, allowing it to regulate pharmaceutical products based not only on the safety of a product but their efficacy as well.

That authority, granted by the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act of 1938, came in the wake of an international regulatory crisis involving Thalidomide, a drug intended to prevent morning sickness in pregnant women which instead caused horrific and debilitating birth defects in their unborn children.

Though many in the US were spared from being exposed to the drug thanks to the efforts of FDA scientist Frances Kelsey, who refused to sign off on the drug's safety, legislators-and in particular Sen. Estes Kefauver -saw an opening to strengthen the country's regulatory system.

Led by Kefauver and Rep. Oren Harris, Congress eventually cobbled together their eponymously named amendments, which were signed into law by President John F. Kennedy on 10 October 1962.

"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 10 October 1962, when President Kennedy signed into law the Kefauver-Harris Drug Amendments," wrote FDA Commissioner Margaret Hamburg in a statement marking the anniversary of the occasion.

The amendments marked a huge shift in the way FDA regulated drugs. Before the amendments, pharmaceutical companies' products were only assessed based on measures of safety-not efficacy. The Kefauver-Harris Amendments changed this by requiring the latter, and further requiring evidence presented to FDA be based on well-designed clinical trials.

In another substantial change, companies were also required to adhere to basic good manufacturing practices (GMPs) and conduct postmarket safety monitoring and surveillance for their products.

"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," explained Hamburg. "The requirements of this law have since then been adopted world-wide, and became the "gold standard" for science-based decisions involving drugs."

"The Drug Amendments of 1962 merit our great praise on their 50th anniversary. They have saved countless lives around the world," she added.


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