29-Oct-12 7:00 AM  CST

The Kefauver-Harris Amendment: Milestones in Drug Approvals

The Food and Drug Administration (FDA) is celebrating the 50th anniversary of the Kefauver-Harris Amendments that have helped ensure effectiveness of prescription drugs for 50 years.  The amendments could have not been possible without a big push from an FDA medical officer and two United States congressmen.  The FDA medical officer was Frances O. Kelsey and the two congressmen were Senator Estes Kefauver of Tennessee and Representative Oren Harris.  The Kefauver-Harris Amendment (amendment to the 1938 Food, Drug, and Cosmetic Act) would change FDA regulatory authority. 
Below are some of the highlights of the amendment which fully heightened consumer protection.  After the legislation was passed the following history making achievements occurred:     
· The FDA was given 180 days to fully check out a new drug application.  With this new law the new application would not automatically become effective. 
· All new drugs must have a positive decision by the FDA before the drug can be marketed. 
· After a drug is marketed, the manufacturers have had to keep records of adverse and negative events associated with the drug. 
· Drug makers have to give significant evidence that their drug is both safe and effective.  The significant evidence comes in the form of controlled clinical investigations and clinical trials. 
With the passage of the Kefauver-Harris Amendment new and innovative strides have been made in the advancement of modern drug approvals.  Pharmacy Technicians can learn a great deal from the passage of the Kefauver-Harris Amendment and see how the drug approval process has changed for the better of all patients.  Interested   Pharmacists and Pharmacy Technicians that wish to help celebrate the milestone amendment may go to http://www.fda.gov/Drugs/NewsEvents/ucm320924.htm to view posters and interactive materials concerning the amendment.   
1. Clarke, Pat.  “50 Years:  The Kefauver-Harris Amendments.”  FDA.  Web.  18 Oct 2012.     
2. FDA Division of Public Affairs.  “Kefauver-Harris Amendment Storyboards.”  FDA.  Web.  27 Oct 2012.

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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