Monday, October 15, 2007

Critics Worry about Makeup of FDA Drug Research Center

Associated Press

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., Pfizer Inc., Wyeth, GlaxoSmithKline PLC, and Johnson & Johnson.

Congress required fast-track creation of the 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 better 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 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.”

Company executives say it’s premature to comment.


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