Healthy Skepticism Library item: 12069

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Drug firm execs to help lead FDA foundation
Associated Press 2007 Nov 20
http://www.msnbc.msn.com/id/21900401/

Full text:

Some say public-private partnership lets businesses cozy up to regulators

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.