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Compliance In Focus
Posted by Shawn Kennedy on Fri, Feb 20, 2015

FDA Kefauver-Harris Amendment (1962)

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recentlyFDA Kefauver-Harris Amendment   released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

Like most Americans, you likely take comfort in knowing that drugs marketed in the United States are available to the public because clinical research studies have demonstrated they are not only safe, but also actually effective at treating the indicated condition.  You may not have known this, but you have the Kefauver-Harris Amendment to thank for this luxury. 

Also known as the Drug Efficacy Amendment, this amendment was signed into law by President John F. Kennedy on October 10th, 1962.  The amendment to the FDA Food, Drug, and Cosmetic Act of 1938 gets its name from the members of Congress who were instrumental in pioneering the bill, Senator Estes Kefauver and House of Representatives Member Oren Harris.

Prior to its passage, manufacturers of drugs could market their products in the United States solely by demonstrating they were safe for humans.  From 1938 until 1962 when the amendment was passed, there was no requirement for drug manufacturers to demonstrate they actually worked.

After its passage, In addition to demonstrating safety, manufacturers were now required to provide proof of effectiveness of their drugs prior to approval.  The amendment also required them to disclose accurate information about their products side effects, and prohibited cheaper generic drugs from being marketed as expensive new “breakthrough” medications.

The primary reason the amendment was passed in the United States was due to the Thalidomide Tragedy that occurred in Europe.  The drug thalidomide became available over-the-counter in Germany starting in 1957.  By 1960, it was marketed in 46 countries (but not the US) to treat nausea associated with morning sickness during pregnancy.  Unfortunately, the potential side effects for using it this way were not fully understood.  As a result, thousands of children were born with birth defects, most notably phocomelia (limb malformations).  Eventually, it ceased to be used to treat pregnant woman, but not until after an estimated 2,000 child deaths and over 10,000 cases of birth defects were noted.  Despite this occurring in Europe, the United States took notice and sought to tighten our regulatory approval process of new drugs.  The Kefauver-Harris Drug Amendment is the primary means by which this occurred. 

To this day, new drugs, and now also new medical devices, must be proven safe and effective before FDA will approve them for use with humans.

Photo Credit: Nicolette Capuano

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Topics: History of Clinical Research, Kefauver-Harris Amendment, IMARC Research, FDA

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