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The Honolulu Advertiser
Posted on: Monday, October 15, 2007

FDA drug research center shows promise

By Matthew Perrone
Associated Press

Hawaii news photo - The Honolulu Advertiser

Janet Woodcock, M.D., is deputy commissioner and chief medical officer for the Food and Drug Administration, which is opening a new drug research center.

JACQUELYN MARTIN | Associated Press

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WASHINGTON — The Food and Drug Administration is moving with unprecedented speed to launch a drug research center to be paid for by companies it regulates.

The goal of the Reagan-Udall Foundation, approved by Congress and signed into law late last month, is to streamline and improve the development of drugs and medical devices, a goal long sought by regulators and the biggest players in the industry, such as Merck & Co. Inc., Pfizer Inc., Wyeth, GlaxoSmithKline plc and Johnson & Johnson.

At a time when the FDA's reputation has been battered by perceptions that it is lax on some safety issues and too cozy with drug makers, consumer advocates say the loosely defined partnership increases the agency's vulnerability to industry clout despite its promise of groundbreaking success. It's an ambitious undertaking that puts regulators and companies in a relationship unlike that of any other industry.

Congress required fast-track creation for foundation. The FDA filed a public notice Oct. 3 that it was accepting board nominations and will name board members Oct. 27. Drug industry executives likely will hold four seats on the center's 14-member board. The rest will be academics, consumer advocates and physicians, with no voting seats for FDA commissioners or staff.

The board's makeup could allow drugs to be developed more cheaply, improving pharmaceutical industry profits, but not necessarily result in safer and less expensive drugs for consumers, critics worry.

"Given FDA's track record in the past, I'm not confident in their ability to create something that is free of influence from industry," said Francesca Grifo, a director at the Union of Concerned Scientists. Her group and others have argued that the agency has become too accommodating to drug companies the past 25 years, after they began paying FDA user fees for the review of drug applications.

"Time and again we've seen that people within FDA behave as if industry is their primary client," Grifo said.

Sen. Edward M. Kennedy, D-Mass., a co-sponsor of the bill to create the foundation, says the bill requires "effective safeguards to ensure that the foundation is independent of both the FDA and its donors, whether those donors are from industry or are charitable organizations."

Reagan-Udall "will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients," Kennedy added in an e-mailed response.

However, the law creating the center leaves crucial decisions to the appointed board — from where the center will be located to how funds will be collected from companies and distributed for research. And there are many unanswered ethical questions, such as who will own patents obtained from the foundation's research and how any potential profits would be shared or distributed.

One crucial issue though seems to have been decided, according to FDA Deputy Commissioner Janet Woodcock: "The FDA intends to put forward a variety of research projects that we think are important, but as with any foundation, the donors will have the primary say over how the funds are used."