13. November 2006 13:41
Congress this month likely will consider a bill to reform FDA, "but the legislation lacks the vision and depth needed for a real return to a science-based FDA," Susan Wood, a research professor for the Project on Scientific Knowledge and Public Policy at the George Washington University School of Public Health and Health Services and former assistant commissioner for women's health at FDA, writes in a Boston Globe opinion piece.
Wood writes that Congress should take several steps to help "a strong, independent and science-based FDA get back on track."
Congress first "should consider making the FDA an independent agency, similar to the National Science Foundation or the Social Security Administration," and should "consider giving the FDA commissioner a fixed term so the commissioner will have some protection from inappropriate political interference," Wood writes.
In addition, "there must be a public way for scientific disagreement within the FDA to be voiced, heard, and responded to in a systematic way," as well as "real authority in labeling and in requiring studies from industry sponsors," Wood writes.
She adds, "Saying that all good scientists have financial conflicts is a red herring," adding, "Truly ensuring that the members of FDA Advisory Committees do not have financial conflicts of interest can be accomplished by actively reaching out to the research community that is publicly funded by" NIH.
Congress also should increase funding for FDA because "right now FDA is stretched too thin," according to Wood.
She writes, "Proposals to expand funding -- such as a consumer fee of several cents per prescription filled -- need to be seriously debated," adding, "Investment in the FDA is worth it" (Wood, Boston Globe, 11/11).
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