As GOP takes aim at FDA, Sharfstein bows out

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The FDA's point-man on prescription drugs, principal deputy commissioner Joshua Sharfstein, left the agency to head up public health in his home state of Maryland.
Sharfstein, who presided over a crackdown on drug and device marketing at FDA, will serve as Maryland's secretary of health and mental hygiene. He headed health in Baltimore before joining the FDA in 2009.
Sharfstein's resignation came amid saber-rattling from the incoming head of the Congressional Committee on Oversight and Government Reform, who vowed to investigate the FDA. Rep. Darrell Issa (R-CA) called FDA “a broken bureaucracy” and said he would hold hearings on FDA failures.
High-pressure hearings are a game Sharfstein knows well, having previously served as an investigator for another Committee on Oversight chairman from California—Democrat Henry Waxman, an inveterate critic of industry promotion.
“He knows what it's like to be under the gun, over and over and over again, by a chairman of a committee trying to help his party regain the White House,” said Coalition for Healthcare Communication head John Kamp, himself a former FCC legislative liaison who remembers his old boss comparing a root canal favorably to oversight hearings.
“It's also just a good career move for a public health official,” said Kamp. “Great job, good jumping-off point to later head FDA, CMS or HHS.”
Former FDA associate commissioner Peter Pitts said the resignation of Sharfstein, whom Republicans view as an overzealous regulator hostile to industry, will make life easier for FDA ahead of contentious PDUFA reauthorization hearings.
“When Sharfstein testified before the 111th Congress, he basically sat down and the members put leis around his neck,” said Pitts. “They were very congratulatory. Had he stuck around, he would have faced some very harsh questions. Putting him up before the 112th Congress would have been very difficult for the agency.”
Pitts called PDUFA reauthorization “an opportunity for the new Congress to make its wishes known to FDA and influence the way PDUFA is written and reauthorized.”
“It's an opportunity to get back to the first principles of PDUFA, which are clarity and predictability versus ambiguity.”
Commissioner Hamburg said that John Taylor, counselor to the commissioner, would serve as interim principal deputy commissioner for the next two months while she reviews the agency's leadership structure.
“In light of these many transitions, I would like to take this opportunity to consult with senior FDA leaders and review certain functions and positions,” Hamburg said in a memo that also noted the retirement of Russ Abbott, a longtime agency hand who was deputy commissioner for administration.
Taylor will bring industry experience to the job, having left the agency after 14 years in 2005 to serve as VP for federal government affairs at Abbott. In 2007, he moved over to biotech trade group BIO, where he was EVP for health, before returning to FDA in 2009. Pitts called him “a talented, devoted public servant and a real standup guy.”
With the White House making very public efforts to repair relations with the business community, you could read it as a peace offering to industry. Just don't bet on FDA easing up on regulation of industry marketing anytime soon.
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