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Pfizer CEO: Independence needed at FDA

Thu Nov 20, 2008 6:19pm EST

Reporter's Notebook

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By Lisa Richwine

NEW YORK (Reuters) - The U.S. Food and Drug Administration was hurt by turnover at the top during the George W. Bush administration and needs a strong, independent leader, Pfizer Inc (PFE.N: Quote, Profile, Research, Stock Buzz) Chief Executive Jeff Kindler said on Thursday.

Four different officials led the FDA during Bush's tenure, which started in 2001. More than half of that time, the top spot was filled by a temporary leader.

"What we've had in the last eight years is we've have had a lot of turnover in the leadership of that agency for a variety of reasons. Any organization, especially one with that kind of scientific mission, benefits from stability in leadership," Kindler told the Reuters Health Summit in New York.

"I don't think it was good for the FDA to have as many changes of leadership that it has had," Kindler added.

During Bush's presidency, the FDA struggled through drug safety controversies and came under attack by lawmakers and consumer groups. Drug makers complained the agency became unpredictable and too focused on drug side effects.

Kindler, head of the world's largest drug maker, said it was a "worthy idea" to consider a fixed term for FDA commissioner. Now, the president can select a new leader at any point during his four years in office. A 2006 Institute of Medicine report recommended a fixed, six-year term.

A fixed term could "would to some extent remove them from the political pressures." Kindler said.

"We need a strong, independent, well-resourced FDA. The starting point for that is to have a commissioner who has strong scientific credentials and credibility and stature who can bring independence to bear on the agency, to ensure that it is proceeding as far from politics as is possible," he said.

The agency has "many, many really terrific, hard-working scientists who are really dedicated to the public health" but are overwhelmed with too much work and not enough funding, Kindler added.

"Their workload exceeds the resources that we have provided to them to do their job, and we have to address that," he said.

Schering-Plough Corp SGP.N Chief Executive Fred Hassan, also speaking to the Reuters summit, endorsed a fixed term for the FDA's top job.

"If you go back to the last several years, it is really a pity that there have been large lots of time when there has been no permanent commissioner in place. We need fixed terms," Hassan said, speaking by telephone.

(For summit blog: summitnotebook.reuters.com/))

(Additional reporting by Ransdell Pierson and Susan Heavey; Editing by Leslie Gevirtz)

 
 
 
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