Lawmakers May Relax FDA Drug Conflict Rules

Congress may soon require the FDA to relax the rules preventing advisers from reviewing a drug if they have even indirect financial ties to related manufacturers. Lawmakers are considering relaxing the regulation, as part of an FDA funding bill, because of complaints that the rules intended to prevent conflicts of interest make it harder to find real experts. More than a third of the FDA's funding comes from fees from drug and medical device manufacturers, meaning that he FDA user fee bill is a popular place to make FDA-related changes. The FDA must often delay panel meetings to search for experts without conflicts, as top doctors are normally the ones hired by drugmakers as speakers or consultants. "We have had difficulty in recruiting highly qualified people. And we've had delays in having panels because of this," says Dr. Janet Woodcock, the head of the FDA's drugs center. As a result, 23 percent of FDA advisory panels have vacancies, more than double the agency's goal, according to an FDA quarterly report released in May.

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