Pharmacy Law: Kefauver-Harris Amendment of 1962

Posted on 12.19.2013

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As pharmacy technicians it is important to be familiar with the laws and regulations that pertain to your industry. Otherwise, you run the risk of violating laws you don’t even know about. The system is complex, but it is very necessary to ensure patient safety. Interrelated laws, regulations, and standards help make sure that the marketing and dispensing of medications is carried out safely and in the public’s best interest.

Over the next couple of weeks and months we will be looking at these different laws. Today we are going to look at the Kefauver-Harris Amendment of 1962.

Kefauver-Harris Amendment of 1962
The Kefauver-Harris Amendment of 1962, named after its sponsors in congress, Sen. Estes Kefauver (D-Tenn.) and Rep. Oren Harris (D-Ark.), was passed in response to the birth of thousands of infants—mostly in Europe—with severe congenital abnormalities whose mothers had taken a new medication (which had proven to be a successful antiemetic for morning sickness) called thalidomide. By 1962, the devastation caused by this drug in other countries had become news in the United States. Thousands of children had been born with shortened, missing, or flipper-like arms and legs.  It extended the FDC Act of 1938 to require that drugs not only be safe for humans but also be effective.

The Kefauver-Harris Amendment changed the following:

  • Required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects.
  • Required that evidence of effectiveness be based on adequate and well-controlled clinical studies conducted by qualified experts. Study subjects would be required to give their informed consent.
  • Gave the FDA 180 days to approve a new drug application, and required FDA approval before the drug could be marketed in the United States.
  • Mandated that the FDA conduct a retrospective evaluation of the effectiveness of drugs approved for safety—but not for effectiveness—between 1938 and 1962.
  • Allowed the FDA to set good manufacturing practices for the industry and mandated regular inspections of production facilities.
  • Transferred control of prescription drug advertising to the FDA, which included accurate information about side effects.
  • Controlled the marketing of generic drugs to keep them from being sold as expensive medications under new trade names.

“The history of drug development in the United States is one of continued progress punctuated by transformative events, and passage of the Kefauver-Harris Amendments is one of those transformative events,” says Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “As a result, FDA’s drug development process is considered the gold standard to which other countries aspire.”