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No Need to Loosen Conflict Rules, U.S. FDA Head Says

No Need to Loosen Conflict Rules, U.S. FDA Head Says

By Anna Yukhananov

WASHINGTON (Reuters) Feb 01 – Congress should not loosen conflict of interest rules to expand the pool of potential U.S. government health advisers, the head of the Food and Drug Administration said on Wednesday.

Lawmakers had proposed bills that would change the rules to make it easier to find more qualified people and speed the review of drugs or devices. The bills would loosen 2007 legislation that barred experts with financial ties to a company or its competitor from serving on an advisory panel.

The head of the FDA’s drugs division testified in August that the agency was struggling to recruit highly qualified people for its advisory panels.

The FDA can use waivers on some potential conflicts to place experts on panels, but the number of allowable waivers has been decreasing.

But today, FDA Commissioner Margaret Hamburg said the conflict of interest rules should remain as they are.

"At the present time, we are not bumping up against our cap in terms of waivers," Hamburg told a hearing of the House Energy and Commerce Committee. "We don’t at the moment see major areas where a legislative fix is required."

Patient and consumer groups contend the FDA is simply not looking hard enough to find experts, and worry that loosening the rules could jeopardize the independence of the panels.

The issue came up earlier this month when a watchdog group urged the FDA to hold a new vote on the risk of blood clots from popular birth control pills because of conflicts.

The group said the FDA’s outside experts had previous research or financial ties to Bayer AG, one of the companies whose pills were under discussion. But the FDA said at the time its rules did not apply to past ties.

Hamburg appeared before the house panel on Wednesday to discuss the reauthorization of a U.S. law that raises funding for the FDA by requiring drug companies to pay fees for product applications.

The focus on conflict of interest rules comes as the FDA faces pressure from some lawmakers and companies to approve more drugs and devices to help promote innovation and jobs.

"Our view is there a need to improve the process of the advisory committees, particularly in areas where there is a paucity of experts," said Geno Germano, the president of Pfizer Inc’s specialty care and oncology unit, who also testified at the hearing.

In her testimony before Congress, Hamburg defended the FDA’s record on innovation and added that job promotion should not be an explicit part of the FDA’s mission.

"I think it will be very hard for us to factor (job creation) into this science-based decision making and how approving or not approving a product will impact jobs, or impact jobs of a competitor," Hamburg said.

"It will get very, very complicated and, frankly, I think would be quite inappropriate. It would not serve the American people well and would not serve industry well."