Drug firm execs to help lead FDA foundation*
Some say public-private partnership lets businesses cozy up to regulators
The Associated Press
updated 1:43 p.m. ET, Tues., Nov. 20, 2007
WASHINGTON - Executives from drug makers Johnson and Johnson and Genzyme
were among those picked to lead a new food and drug research foundation
that brings private companies into an unusually close relationship with
regulators.
The Food and Drug Administration last week announced the board members
of the Reagan-Udall Foundation, a partnership between the public and
private sectors aimed improve oversight of products regulated by the
agency, while accelerating the development of drugs and other medical
products.
Along with J&J and Genzyme, other industry representatives on the board
include executives from General Electric Co., which makes medical
devices, and the Grocery Manufacturers Association, whose members
include Hormel Foods Corp. and Kellogg Co. (Msnbc.com is a joint venture
between Microsoft and NBC Universal, which is owned by GE.)
The remaining seats on the 14-member board include representatives from
academia, the health professions and nonprofit advocacy groups. No
government officials are permitted to serve as voting members of the
board of Reagan-Udall, which was created as part of a major FDA overhaul
signed into law in September.
The law creating the center required that at least four board members
come from industries regulated by FDA.
Former FDA Commissioner Mark McClellan will serve as chairman of the
board. McClellan left the agency in 2004 to run the Centers for Medicare
and Medicaid Services. Since leaving that position last year, he has
conducted research at the Brookings Institution and the American
Enterprise Institute, both Washington think tanks.
Although Reagan-Udall is affiliated with FDA, the center will primarily
be funded by donations from private companies. The center's board is
tasked with awarding those funds to researchers in government, academia
and industry.
Consumer advocates and some lawmakers have criticized the loose
partnership, arguing that allowing companies to fund
government-sanctioned research could increase FDA's vulnerability to
industry clout.
Earlier this month, Rep. Rosa DeLauro, D.-Conn., sent a letter to FDA's
Commissioner Andrew von Eschenbach stating "the potential for pressure
on FDA staff from Reagan-Udall Foundation-endorsed research is
enormous." Specifically, DeLauro asked how FDA would be able to
objectively review products that incorporate its own research.
The congresswoman's staffers said Friday they have not yet received a
response to the letter.
Under the law creating Reagan-Udall, the board's first task will be to
draft guidelines for how the foundation will operate, including the
collection and distribution of funding. A spokeswoman for FDA said the
board's first meeting has not yet been scheduled.
Copyright 2007 The Associated Press. All rights reserved. This material
may not be published, broadcast, rewritten or redistributed.
URL: http://www.msnbc.msn.com/id/21900401/
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