FDA Proposes Rules to Prevent Conflicts of Interest Among Agency Advisory Committee Members

March 24, 2007 – The Food and Drug Administration (FDA) has announced proposed rules under which medical experts with more than $50,000 financial interest in pharmaceutical companies could not serve on agency advisory committees that review their products or the products of their competitors. Under the proposed rules, medical experts with less than a $50,000 financial interest could participate in discussions by advisory committees but could not vote on whether to recommend products. The $50,000 limit includes stock and consulting arrangements. In addition, FDA would individually review cases in which academic researchers have potential conflicts of interest that result from funds or research grants paid to their institutions by pharmaceutical companies. In rare cases FDA could make an exception to the rules in the event that the agency commissioner considers the participation of a medical expert necessary to a discussion of an advisory committee. Under the current rules, medical experts with more than $100,000 or 15 percent or more of their net worth invested in pharmaceutical companies cannot serve on advisory committees. Medical experts must disclose smaller investments in pharmaceutical companies, but such investments do not prevent their participation on advisory committees.

Initial congressional reaction has been favorable with several Members of Congress indicating that the proposed guidelines implicitly acknowledge critics’ claims of an industry bias at the Agency.

View ASH’s policy statement concerning support for conflict of interest regulation at federal research agencies.