Report: FDA deputy Sharfstein to step down

January 4, 2011 By MassDevice staff

Dr. Joshua Sharfstein, deputy commissioner of the Food & Drug Administration, is stepping down for the top job in Maryland’s public health department, according, un-named officials told the Wall Street Journal.

Sharfstein, formerly Baltimore’s top public health official, is slated to be named secretary of health and mental hygiene for Maryland by Gov. Martin O’Malley, according to “government officials familiar with the issue” cited by the newspaper.

Sharfstein declined to comment, the newspaper reported; a spokesman for O’Malley wouldn’t confirm Sharfstein’s appointment, but noted that O’Malley intends to make an announcement about the post tomorrow.

Starting with his brief tenure as acting commissioner in 2009, Sharfstein shook up the agency in a series of moved aimed at addressing safety issues. Most prominently, he helmed a probe into the watchdog’s controversial 2008 clearance of ReGen Biologics Inc.’s (OTC:RGBO) Menaflex knee implant. That probe led to the agency’s decision to put the device through its paces again, which in turn prompted the rescission of the clearance and a feisty response from ReGen.

The Menaflex 510(k) clearance in December 2008 came despite the fact that the device often failed and required second operations — and over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.

In March, the agency’s Orthopaedic and Rehabilitation Devices Panel at the Center for Devices and Radiological Health decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying Regen failed to produce adequate evidence that device was safe before it was cleared to hit the market.

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