FDA

FDA Deputy Commissioner tough on medical devices resigns

Friday, January 14, 2011 by: Jonathan Benson, staff writer
Tags: FDA, medical devices, health news

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(NaturalNews) After serving less than two years as the Deputy Commissioner of the U.S. Food and Drug Administration (FDA), Joshua Sharfstein recently announced that he is resigning from his position at the agency to become head of Maryland's Department of Health and Mental Hygiene. During his time at the FDA, Sharfstein took some aggressive steps to crack down on unsafe medical devices that were on the market, which some say may have played a role in his ultimately stepping down.

Sharfstein was not always a friend to the industry that he regulated, which is uncharacteristic of most higher-ups at the FDA. He played an important role in sparking the Avandia safety review that led to the unsafe drug earning tighter use restrictions, for example. And he also went after medical device manufacturers that have long taken advantage of the poor regulatory standards employed by the FDA.

One of the most aggressive courses of action Sharfstein took during his time at the FDA was the prosecution of drug company executives, rather than just the companies themselves, for crimes committed. GlaxoSmithKline, for instance, saw one of its top lawyers indicted as part of a joint investigation by both the FDA and the U.S. Justice Department.

Under Sharfstein's leadership, the FDA seemed to be headed somewhat in the direction it should have been headed all along -- it was actually beginning to hold the industries it regulates responsible for the unsafe drugs and medical devices they produce, while also prosecuting the individuals in those industries found responsible for illegal activity.

On the other hand, Sharfstein also set up the 2009 FDA press conference to announce that electronic cigarettes contain certain questionable chemicals like diethylene glycol that the agency says may be unsafe. This is at the same time that FDA-approved nicotine patches with the same chemicals are being sold to consumers without question.

Sources for this story include:

http://online.wsj.com/article/SB100014240527...

http://www.nytimes.com/2009/07/23/health/pol...

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