FDA's No. 2 To Return To Md. As Health Secretary
BERLIN, Md. (AP) -- Joshua Sharfstein, the Food and Drug Administration's number two official, is leaving the Obama administration and returning to Maryland to become the state's top health official there as Republicans take control of the U.S. House of Representatives, vowing to scrutinize agencies like the one Sharfstein helped oversee for more than a year.
Sharfstein, who served as Baltimore's health commissioner before joining the FDA, will be Maryland's next secretary of the Maryland Department of Health and Mental Hygiene, Gov. Martin O'Malley, a Democrat, said Tuesday.
Sharfstein is principal deputy commissioner at the FDA under Commissioner Margaret Hamburg. The pair are credited with stepping up enforcement of marketing and manufacturing rules for pharmaceutical and medical device companies.
"I recruited Josh and hired Josh to be our health commissioner in Baltimore city, and I'm very delighted that he's willing to leave what is already a very important national position to come back to Maryland and to help us, especially at this time of transition into health care for all," O'Malley said.
President Barack Obama tapped Sharfstein in 2009 to try and bolster the agency's image as watchdog after criticism that the FDA had become too close to the companies it regulates.
Under Sharfstein's leadership, the agency expanded its oversight of new products, including a crack down on highly caffeinated alcoholic beverages like Four Loko and an attempt to regulate electronic cigarettes.
Sharfstein also oversaw a review of the agency's system for reviewing medical devices. In an unprecedented step, the agency acknowledged it inappropriately approved a knee repair device due to outside lobbying efforts.
With Republicans now controlling the House of Representatives, Sharfstein was expected to face scrutiny from lawmakers overseeing the agency. Earlier this year he was asked to testify twice on FDA's oversight of Johnson & Johnson.
Johnson & Johnson executives and the Food and Drug Administration both shouldered the blame for a secret recall in which hired contractors quietly bought up defective painkillers to clear them from store shelves. Sharfstein, said his agency should have acted sooner to halt J&J's plan. At the same time, though, he stressed that regulators were not aware of the deceptive nature of the recall.
The hearings were part of a broader investigation into quality control problems at J&J that have triggered more than a dozen recalls in the past year. The largest recall involved more than 135 million bottles of infants' and children's Tylenol and other medicines.
Rep. Darrell Issa of California, who is set to lead the House Oversight and Government Reform committee, said Sunday that the FDA would be an area of investigation in the coming year.
Sharfstein will replace John Colmers, who resigned as Maryland's state health leader.
(Copyright 2011 by The Associated Press. All Rights Reserved.)
