By Lisa Richwine and Kim Dixon
NEW YORK (Reuters) - Growing attention from the U.S. Congress and others is weighing on Food and Drug Administration staff who review medical products, a top FDA official said on Tuesday.
Since Democrats took over Congress in January, lawmakers have increased their FDA oversight. Many agency reviewers have been called to brief congressional staff who are probing agency decisions, FDA Deputy Commissioner Janet Woodcock said.
"Our staff is sort of wearing a path down there now," Woodcock said at the Reuters Health Summit in New York.
Many FDA staffers "have been called down personally to Congress. They have been named in the media. They have been attacked at advisory committees by various victims, relatives who have experienced adverse events. They have been talked about obliquely and sometimes directly" in medical journals.
While attention traditionally has focused on the FDA commissioner or other top officials, "this era of pointing down in the organization and saying, 'you did this or you did that' is new," Woodcock said.
Reviewers have "a concern in their mind ... about their own personal accountability for their scientific judgment," said Woodcock, also the FDA's chief medical officer and the acting head of its drug division.
Various congressional committees have been investigating the FDA's handling of safety concerns with GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research, Stock Buzz) diabetes drug Avandia and the Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) antibiotic Ketek, plus many other issues.
"I'm proud of our oversight," Rep. Bart Stupak, who chairs the House of Representatives Energy and Commerce subcommittee on oversight and investigations, said in a phone interview. Continued...
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