The draft guidance would require more disclosure regarding possible conflicts of interest, to post the name of the company or institution online, along with details of the specific nature of the conflict of interest.
FDA Commissioner Margaret Hamburg said in a letter to senior agency officials: “In my view, it is clearly better for the agency in fulfilling its public health mission when advisors have no conflicts of interest. FDA staff should search far and wide for experts who have the requisite knowledge without conflicts of interest. At the same time, however, I recognize the fact that many of the top authorities in specific areas may have conflicts of interest.”
Hamburg said that it is necessary to appoint someone with sufficient expertise to an advisory committee and sometimes conflicts of interest were unavoidable. However, she said there should be a requirement that waiver recommendations are properly justified along with a detailed explanation of the search for an equally qualified individual without conflict of interest.
She added that “not all conflicts are created equal,” giving the example of an academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies.
This is “a more tangential relationship to the conflict” than that of a researcher involved in directly conducting studies for a company, she said.
Hamburg also said that the type of advice to be provided by the committee should be considered, with waivers possibly being more appropriate for meetings about policy issues affecting a category of products than for meetings examining whether to approve a specific product.
The draft guidance can be accessed via this link.