Senate Votes to Require Greater Transparency on Conflicts of Interest at FDA|
Statement of CSPI Integrity in Science Director Merrill Goozner
The amendment passed by the Senate last night is a step in the right direction. We congratulate the Senate and particularly Senator Richard Durbin, who led the effort. Consumers concerned that drug, device and food manufacturers have corrupted the FDA’s advisory committee process may soon have 15 days notice when the FDA wants to put scientists with conflicts of interest on one of its 30 advisory panels. Simultaneous publication of the waivers granted to scientists, along with their conflicts, gives the public additional information for evaluating whether their participation may taint the proceedings. Under the current system, where the waivers are kept under wraps pending a Freedom of Information Act request that can take years, the public is effectively kept in the dark about the ties between some scientists on FDA panels and the companies whose products are up for approval.
However, this bill does not go far enough. CSPI believes the FDA can find qualified scientists without conflicts of interest to serve on all of its advisory panels. That’s why the waivers should be disallowed in all but the most extraordinarily circumstances (there may be some rare-disease exceptions). Moreover, in no cases should scientists with conflicts of interest be allowed to vote at the conclusion of a committee’s deliberations.
We’re glad the Senate included a provision requiring the agency report to the Health and Human Services Inspector General what steps it took to find unconflicted scientists when it staffs an advisory committee. This will encourage the agency to seek out more of the nation’s highly qualified scientists who do not have financial ties to industry.