The US Food and Drug Administration has laid out new guidelines that it will help it adopt “a more stringent approach for considering potential conflicts of interest for its advisory committee members.”
The agency’s acting deputy commissioner for policy, Randall Lutter, said the guidance it is issuing will make the process more rigorous and transparent “so that the public has confidence in the integrity of the recommendations made by its advisory committees." He added that it should provide more consistency in deciding who is eligible to participate in the meetings “and would simplify the process."
The FDA currently screens all prospective participants before each meeting to determine whether the potential for a financial conflict of interest exists and it has the power to grant a waiver when certain criteria are met, such as when the need for an individual's expertise outweighs a possible conflict of interest. However, the present system, based on a guidance issued in 2000, is too complex, the agency claims, adding that “FDA officials found it difficult to achieve consistent results that the public could readily understand.”
Now, under the terms of the new guidance, panellists who hold financial interests in drugmakers of over $50,000, be it through stocks, grants or consulting fees, will be barred from advising the agency, regardless of their expertise, while people receiving less than that from the industry may be eligible to sit on a panel but only as non-voting members and only if the need for their services outweighed potential conflict.
Dr Lutter noted that these new procedures will affect a significant number of people already serving on advisory committees and claimed that the $50,000 limit strikes a balance between the need for scientific input, transparency of the process and public confidence.
The move was welcomed by some of the agency’s biggest critics. Peter Lurie, deputy director of the health research group at Public Citizen, the influential US consumer entity, said that “this is a movement away from FDA's prior claim that you can't find sufficient expertise among people without conflict. It is also a movement away from a growing trend in medicine, that you can manage conflict of interest."