The US Food and Drug Administration has announced a plan to revamp its system of advisory committees, in the face of criticism about its policy on conflict of interest waivers and the threat of legislation that could bar some advisors from taking part.
The agency said it aims to make the process of granting waivers more transparent, particularly the conditions under which they are disclosed to the public, and divulge more information than it has to date.
But in an impassioned speech in front of the Center for Science in the Public Interest, Scott Gottlieb, deputy commissioner for medical and scientific affairs at the FDA, said it was imperative that the agency can continue to draw on the best expertise, even from those who may have a conflict of interest.
Pointing out that the success of top medical specialists and clinical triallists almost invariably means they will be engaged in other enterprise, he told the CSPI that “it would be a significant step backwards if our primary criterion for selecting members to our committees becomes their lack of private sector work, if we exclude people for deep experience rather than embrace them for it.”
Gottlieb’s comments come shortly after US Representative Maurice Hinchey tabled an amendment to the spending bill that funds the FDA, which would bar the agency from granting any waivers to allow experts a conflict of interest to sit on panel meetings charged with recommending whether to approve new prescription drugs and medical devices.
“Saying that there are not enough potential advisory panel members available without conflicts, as the FDA argues, is an empty claim,” said Hinchey in a statement earlier this week.
"A study earlier this year found that 28% of FDA advisory panel members disclosed a financial conflict of interest, which is certainly a large enough percentage to change the outcome of a panel's vote. Even more disturbing is the fact that the FDA denied waivers to those with conflicts only 1% of the time.”
The Pharmaceutical Research and Manufacturers of America lent its support to Gottlieb’s stance, noting that just because there is a potential conflict of interest, that doesn’t mean their judgment will be swayed.
This view was backed up by a report published in April by consumer group Public Citizen, which found that while members of FDA advisory committees often have financial ties to the companies whose drugs they are evaluating, the relationships rarely affect their decisions.
While it found a weak correlation between these ties and voting behaviour, excluding those advisory committee members from the FDA panel process would not have altered the overall outcome at any meeting studied, it said.