FDA official: reviewers under pressure

-Reuters

11/14/07 - 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 diabetes drug Avandia and the Sanofi-Aventis 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.

Woodcock said Congress has made "a tremendous number of document requests" that take time to answer, she added.

"Everybody has to search their files. The atmosphere is somewhat intimidating," she said. Asked if the time needed to respond was detracting from the agency's scientific mission, Woodcock said "definitely."

"I think it does take a hit on morale. People feel worried," Woodcock said, speaking to Reuters Television.

She added, however, that "I think we're turning a corner on that."

"We need to show the public and Congress how we are dealing with these issues. And I think we can move ahead," she said.

FDA critics cite several cases to justify added scrutiny, including the handling of arthritis pill Vioxx, which Merck & Co withdrew in 2004 because of a link to heart attacks. One agency safety officer said he felt pressured by superiors to water down findings about the drug's risks while it was being sold.

Stupak said multiple investigations were necessary because "there are just so many incidents where they just are not doing their job," pointing to food safety concerns and the handling of Avandia and Ketek, among other issues.

"We look forward to the day when FDA oversight won't be needed," said Jill Kozeny, a spokeswoman for Iowa Republican Sen. Charles Grassley, a frequent FDA critic.

Woodcock did say it was "better for FDA to have interactions, contact with Congress" and that lawmakers had just passed major FDA legislation that she thought would be "very beneficial for the agency, for the public."

The law increased drug-industry funding for product reviews and strengthened FDA power over drugmakers after a medicine reaches the market.

"We don't object to oversight, but you have to recognize the review staff does feel concerned," she said.

Some chief executives at the Reuters Health Summit also lamented increased pressure by Congress on the FDA.

GlaxoSmithKline CEO Jean-Pierre Garnier said lawmakers had been "issuing critical press releases, creating unnecessary turmoil."

"The FDA should be left alone to do that job. They are not immune to the pressure they are under," Garnier said.

That appears unlikely, according to Stupak.

"This is only my first year. I have not yet begun to turn up the heat," Stupak said.

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