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New FDA drug research center holds promise, but industry influence poses worrisome risk

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WASHINGTON (AP) -- 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. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), Wyeth (NYSE: WYE), GlaxoSmithKline plc (NYSE: GSK) and Johnson & Johnson (NYSE: JNJ).

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 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 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."

Company executives say it's premature to comment on questions about Reagan-Udall, but they do say, as do FDA officials, that they hope the foundation reverses an alarming imbalance between how much companies spend on drug research and the number of drugs making it to market. Drug R&D spending hit $43 billion in 2006, a 150 percent increase the past decade compared with a 2.5 percent rise in the number of new FDA drug applications during that period.

The problem is time and money. Companies on average spend almost 15 years and $1 billion to get a new drug to market, according to the Pharmaceutical Research and Manufacturers of America. The drug development process can involve tracking up to 15,000 patients taking a drug for as long as five years.

At Reagan-Udall, FDA scientists, with private-sector funding, are hoping to do world-class research not being done elsewhere while giving pharmaceutical companies a role in developing more effective drug approval methods and standards.

It's part of the FDA's Critical Path Initiative, unveiled in 2004, which calls for the agency to work with industry and academia to speed the "critical path" a drug travels from discovery to market. But critics question the potential trade-offs.

"FDA's primary role is regulating drugs and protecting the public health," said David Ross, a former FDA safety reviewer at the Department of Veterans Affairs. "If you start blurring that line between regulation and collaboration, you have real problems."

For example, Ross, who left the FDA last year over a drug safety dispute, is concerned, as are others, that the FDA might be persuaded to quickly adopt a controversial drug-testing process that uses biological indicators, such as blood pressure and cholesterol levels, to determine a drug's safety.

Drug companies have taken the unusual step of sharing research data on these indicators, called biomarkers, to see if the size and duration of patient drug trials can be reduced. Some critics call their use a high-risk gamble.

"Biomarkers are a bit like dynamite in that they can be extremely useful but they can cause a lot of damage," said Ross.

He cites a biomarker that suggested irregular heart rhythms were a key predictor of fatal heart attacks. Using the assumption, doctors prescribed heart-regulating drugs to millions of patients in the 1980s, but abruptly halted the practice in 1989 when a long-term study revealed patients were actually more than twice as likely to die of sudden heart failure.

FDA officials counter that HIV biomarkers have turned out be a reliable predictor of survival for patients susceptible to AIDS, a disease that can fatally damage the body's ability to fight off serious illness.

Rachel Behrman, who heads FDA's Office of Critical Path Programs, says it's too early to know whether biomarker research would be an initial project. She wants to focus on the opportunities the center will offer.

"This has to do with being smarter," Behrman said. "That's what this initiative is about."

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