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POGO to FDA on Conflicts of Interest: Disclose Them!

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Last month, in a piece titled “FDA Advisers’ Financial Ties Not Disclosed,” The Wall Street Journal reported on an alarming Food and Drug Administration (FDA) practice—many doctors and scientists who serve on panels that review new medical devices and drugs have financial ties to the companies that are producing those products. The FDA requires these professionals to disclose these financial ties to the FDA, but keeps the information confidential, even from the other panelists.

FDA advisory panels consist of doctors and scientists from outside the FDA who provide recommendations to the agency on issues surrounding the approval of new medical devices or drugs. The FDA often follows the recommendations of the advisory panels. As The Wall Street Journal article points out, some doctors and scientists who sit on these panels consult for the very companies that produce the medical devices and drugs they are asked to review. While doctors and scientists must inform the FDA about any potential conflicts of interest before serving on a panel, these disclosures to the FDA are not made public unless the FDA determines they are severe enough to warrant further disclosure; however, this happens less than 1 percent of the time. The FDA has evidently decided that many potential conflicts of interest do not require public disclosure. The Project On Government Oversight does not agree.

This alarming secrecy is not a new issue. POGO warned of potential pitfalls of this practice three years ago in a letter to Dr. Margaret Hamburg, Commissioner of the FDA. We pointed out that these potential conflicts have the possibility of decreasing public confidence in FDA decisions and, more seriously, that they may lead to the approval of unsafe medical products. We pointed out that the FDA’s decisions to approve medical devices or drugs may be compromised when the panelists who make those recommendations have what appear to be financial conflicts of interest.  While financial interests need not be an automatic bar to serving on these panels, POGO believes that transparent public reporting of financial interests would be greatly beneficial in this context.

Today, POGO sent another letter to Dr. Hamburg, reiterating our concerns, which have not been addressed. As the current FDA policy stands, some medical journals require more transparency from their authors than the FDA does from its medical device and drug panelists. POGO’s letter suggests that the FDA should adopt the same disclosure standards used by those medical journals, as they get information out without being unreasonably invasive. The FDA should create a system through which financial ties between advisors and the manufacturers of medical devices and drugs are disclosed to the public.

By: Elizabeth "Liz" Hempowicz
Director of Public Policy, POGO

Photograph of Elizabeth Liz Hempowicz is the Director of Public Policy for the Project On Government Oversight.

Topics: Public Health and Science

Related Content: Food and Drug Administration, Conflicts of Interest, Federal Advisory Committees

Authors: Elizabeth "Liz" Hempowicz

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