FDA policy change would limit funds given to advisers

April 3, 2007

Washington - The Food and Drug Administration (FDA) is moving to ban scientists from serving on agency advisory panels if those scientists receive more than $50,000 from drug and medical-device companies.

Washington - The Food and Drug Administration (FDA) is moving to ban scientists from serving on agency advisory panels if those scientists receive more than $50,000 from drug and medical-device companies.

The policy changes would take effect later this year, after the FDA considers public comments, according to the Boston Globe.

Consumer advocates and others have long sought to eliminate or diminish the role of scientists who receive funding from drug and medical-device companies and serve on advisory panels that make decisions affecting those companies’ products.

“I think the FDA’s decision is appropriate and long overdue,” Boston-based dermatologist Ranella Hirsch, M.D., tells Dermatology Times. “I think we have an agency that sometimes can be subject to corporate influences.”

The new regulations would cover doctors and researchers who received more than $50,000 in consulting fees or research grants in the previous 12 months from drug and medical-device companies with a financial stake in FDA decisions. The caps would also include the value of stock purchases over which the potential advisers have direct control. Researchers receiving less than $50,000 could attend meetings and participate in debates as advisers, but would not be allowed to vote.

The Globe article cites a study published in 2006 by the Journal of the American Medical Association showing that of 221 FDA meetings held by 16 advisory committees from Jan. 1, 2001, to Dec. 31, 2004, 73 percent included at least one adviser with financial ties to drug companies. The 376 federal advisers who served on those panels reported 11 direct financial conflicts of interest exceeding $50,000 in value, the study said. Nineteen percent of the advisers who were drug company consultants were paid more than $10,000 during the previous year.

According to the Globe, Randall Lutter, the FDA’s acting deputy commissioner for policy, said the proposal “strikes an appropriate balance” between the agency’s need to tap scientific researchers’ expertise and its need to ensure public confidence in its decision-making.

The Globe reports that some congressional advocates for FDA policy change consider the agency’s move inadequate. In a statement issued by her office, U.S. Rep. Rosa L. DeLauro (D-Conn.) said, “I am concerned that a closer inspection of the plan’s details will reveal the loopholes that would render it toothless. It would be very troubling if these doctors were also serving on an advisory committee and have the potential of reviewing data in a way that favors the industry over the patient.”

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