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Concerns Raised About Private-Public Research Partnership To Support FDA

Armen Hareyan's picture

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

The 14-member board of thefoundation must include three academics, two consumer advocates, onehealth 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 areconcerned 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).

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Thefoundation 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.

Criticsare concerned that if drug makers gain too much influence on thefoundation, the resulting criteria established for evaluating productscould be excessively industry-friendly. Merrill Goozner, head of theCenter for Science in the Public Interest's Integrity in Science Project,said, "The last thing you want is an industry-run board in which theycreate a science-sounding rationale before they put the FDA rubberstamp of approval on something that hasn't been proven." DianaZuckerman, 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 thereforethey're going to control the executive director, staff and theresearch."

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

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