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FDA Medical Device Chief Resigns After Complaints

Wed, 08/12/2009 - 1:23pm
Matthew Perrone, AP Business Writer

WASHINGTON (AP) — The head of the Food and Drug Administration's medical device division announced he will step down, months after scientists under his leadership alleged they were pressured to approve certain products.

In a letter to agency staffers obtained by The Associated Press, Daniel Schultz said he and FDA Commissioner Margaret Hamburg agreed his resignation "would be in the best interest of the center and the agency."

FDA's device division, which Schultz led for five years, has been under scrutiny since earlier this year when nine scientists wrote to the Obama administration transition team complaining they were pressured to approve medical devices against their professional judgment.

Since then, lawmakers including Rep. Henry Waxman, D-Calif., and Sen. Chuck Grassley, R-Iowa, have sent letters to FDA investigating the matter.

Specifically, between 2006 and 2008, FDA scientists repeatedly rejected a knee repair device from Regen Biologics, a company based in Hackensack, N.J. In a 2007 rejection letter to the company, an FDA reviewer said the company's device had "an increased risk" compared with products already on the market. FDA scientists recommended rejecting another application from the company in fall 2008, saying Regen had not shown "that patients who received the device experienced any benefit."

Despite these concerns, Schultz approved the device in late 2008.

Consumer health advocates hailed the news of Schultz's departure as evidence of a new direction at the FDA.

"This change in leadership will bring hope to many patients who have been very concerned about the safety of medical devices," said Dr. Diana Zuckerman, of the National Research Center for Women and Families in Washington.

The FDA has been plagued for years by criticisms of dysfunction, following the recalls of drugs like Vioxx — which was linked to heart attack and stroke years after its approval — and a string of outbreaks of food-borne illnesses like salmonella.

President Obama tapped Hamburg, a former New York City health commissioner, earlier this year to try and restore the agency's credibility. Hamburg said Tuesday that Associate Commissioner Jeff Shuren would serve as interim director for devices until a permanent replacement is found.

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