Concerns Raised About New Private-Public Research Partnership To Support FDA

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry
Article Date: 05 Oct 2007 - 10:00 PST

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FDA seems to be moving "with unusual speed" to organize a private-public foundation to help support the agency, and some critics are saying the initiative might be "little more than a front for the industries it regulates," CQ Today reports. The group, known as the Reagan-Udall Foundation, was established in the FDA reauthorization legislation, which President Bush signed into law Sept. 27.

The 14-member board of the foundation must include three academics, two consumer advocates, one health care provider, four industry representatives and four "at-large" members with "experience relevant to the purpose of the foundation." While five of the nominees will be chosen by FDA, some critics are concerned the at-large seats will be filled by industry representatives (Adams, CQ Today, 10/2). FDA began taking nominations on Wednesday (Edney, CongressDaily, 10/3).

The foundation largely will be financed through private donations, including those from food, pharmaceutical and medical device companies, according to CQ Today (CQ Today, 10/2). It is meant to help fund research to modernize the agency, according to CongressDaily.

Critics are concerned that if drug makers gain too much influence on the foundation, the resulting criteria established for evaluating products could be excessively industry-friendly. Merrill Goozner, head of the Center for Science in the Public Interest's Integrity in Science Project, said, "The last thing you want is an industry-run board in which they create a science-sounding rationale before they put the FDA rubber stamp of approval on something that hasn't been proven." Diana Zuckerman, president of the National Research Center for Women & Families, said, "You have a situation where most of the money will be from (industry groups) -- they're going to control the board and therefore they're going to control the executive director, staff and the research."

A spokesperson for Senate Health, Education, Labor and Pensions Committee ranking member Mike Enzi (R-Wyo.) said the mission of the foundation is to conduct research that the pharmaceutical industry is unable to do, not to give industry any unfair advantages (CongressDaily, 10/3).

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