FDA Examines Kefauver-Harris Amendments’ Impact on Drug Safety

Posted on October 17, 2012

In honor of the 50th anniversary of what’s known as the Kefauver-Harris Amendments, the passage of which became a landmark in drug safety, the Food and Drug Administration is looking into the history of this moment and its impact on the country.

In the late 1950s, Senator Estes Kefauver led a Subcommittee that sought to figure out how the Food, Drug & Cosmetic Act could be strengthened.  This senator had a desire to pass legislation that would force drug manufacturers to be truthful in their packaging and the claims they made in their various marketing materials.  He felt that consumers were often being misled and forced to pay exorbitant amounts of money for drugs.

But it wasn’t until the William S. Merrill Company attempted to bring a product known as Kevadon to the market that the seriousness of the issue was brought into stark relief.    This drug was a type of thalidomide, which was supposed to treat morning sickness in pregnant women.  However, in Europe, Canada, and a handful of other countries where the sedation was already available, a number of birth defects had been reported in conjunction with the usage of the drug.  Kids numbering in the thousands had such defects as missing or shortened appendages.

An FDA medical officer put a halt to the impending approval of the drug, stating that clinical data was not sufficient so as to demonstrate safety.  Unfortunately, it was determined that 1,200 doctors throughout the country had already been given Kevadon by the company.  The FDA attempted to get the drug back from affected facilities and consumers, but even still, 17 instances of a birth defect occurred in the United States.

On October 2, 1962, Congress gathered to unanimously pass the Kefauver-Harris Amendments, which now included language from the FDA that specifically sought to avert the type of widespread health threat that resulted from the Kevadon incident.  It was these amendments that made it so that drug manufacturers are required by law to demonstrate through clinical trials and other means that a given item is effective before it’s brought to the market.  Plus, if a dangerous side effect was later discovered, those same companies would have to make the occurrence known to federal authorities.

The Food and Drug Administration was also given sole authority to approve a drug for the United States, and if a drug didn’t meet their requirements, it could not be marketed.  Applications would need to be considered by the FDA within six months.  The FDA would also be handed oversight over advertising claims and the marketing of generic drugs so as to keep costs down on the latter.  Plus, drugs that had already been released before 1962 were now subjected to scrutiny by the organization.

50 years later, we’re still feeling the repercussions of this important legislation.

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