9-Feb-15 10:00 AM  CST

FDA Commissioner Elects to Step Down from Post

The Food and Drug Administration (FDA) is the federal agency responsible for the safety of medications, medical devices and cosmetics. Formed under the 1938 Federal Food, Drug and Cosmetic Act, the FDA has long been the watchman for the American public. However, the FDA has not been without its challenges, and this year has been no exceptions. On February 5th 2015 the current commissioner of the FDA, Dr. Margaret Hamburg announced that she would be stepping down from her post in March. Dr. Hamburg was appointed to the FDA from the Obama administration and after six years feels it is time for her to move on with her career.

When Dr. Hamburg took over her post at the FDA the agency was suffering from image problems due to regulatory issues related to Vioxx. Vioxx was a non-steroidal anti-inflammatory drug (NSAID) much like Celebrex, used to treat the effects associated with joint pain. The drug, which worked well for many, was linked to significant cardiac problems and thousands cardiac death are believed to have been linked to the drug. In 2004 the FDA pulled Vioxx the U.S. market.

In her tenure as FDA commissioner Dr. Hamburg has battled some of the most alarming issues related to healthcare. Opioid abuse and obesity are just two examples of the healthcare related issues the FDA has struggled with during Dr. Hamburg’s commission. In the 6 years that Dr. Hamburg was at the helm of the FDA more than 14 new drugs were approved for use in the U.S, an astonishing feat and the most approved drugs in 20 years.

Dr. Hamburg has managed to pilot the FDA through horrific incidences of death related to contaminated injectable steroids in Massachusetts and continued controversy with the “morning after pill”. The job of FDA commissioner is tireless and one that is not for the weary. Dr. Hamburg has stated, “She had never expected to stay as long as she did”

 

 

Resources:

“FDA Commission Margaret Hamburg to Step Down” (2015) FierceBiotech, http://www.fiercebiotech.com/story/fda-commissioner-margaret-hamburg-step-down/2015-02-06, retrieved, 7. February 2015

Tavernise, S, (2014) “FDA Commissioner leaving after 6 years of breakneck changes”, New York Times, http://www.nytimes.com/2015/02/06/health/margaret-hamburg-fda-commissioner-stepping-down.html?ref=health&_r=0, retrieved, 7. February 2015

 


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Source: Sandy Andrews  

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