Thursday, February 7, 2008

Recently, congressional hearings were held about the growing gap between the scientific resources the Food and Drug Administration has at its disposal and the various responsibilities to both police and improve the public health. The hearings followed a searing report by the FDA’s Science Advisory Board that concluded, “FDA’s inability to keep up with scientific advances means that American lives are at risk.” The problem: Congress adds new responsibilities but not the corresponding resources even as it blames the FDA for falling short of the new regulations it must enforce.

Science Board member Garret FitzGerald, a University of Pennsylvania pharmacology professor, cites a “cabal of congressional majorities and presidential administrations that has serially stripped the agency of assets.” When politicians even drive away the agency’s private support and voluntary participation, you know that at the heart of the FDA’s problem are pols willing to attack the agency for political gain.

The Science Board points to the dire need for the FDA to collaborate with academic and private-sector scientists as part of the agency’s Critical Path Initiative to use 21st century science to make drug development safer and more predictable.

Yet Rep. Rosa DeLauro, chairman of the appropriations subcommittee controlling the FDA budget, stripped $1 million for the FDA’s non-profit Reagan-Udall Foundation, which Congress created to support such teamwork. The congresswoman, who took home to Connecticut $25 million in earmarks, blocked funding because she thinks certain individual appointments to the foundation, which has no regulatory authority, have conflicts since they work with industry. Considering the foundation is designed to promote collaboration, it would be a surprise if they didn’t have such ties.

Now a program to establish guidelines on how to use genetic tests called biomarkers to predict who responds best to cancer drugs could be delayed for months as the foundation scrounges for money. Worse, Rosa DeLauro is on record as claiming biomarkers are weak measures of a drug’s effectiveness even as the director of the NIH National Human Genome Research Institute, Dr. Francis Collins, hails them as the next revolution in medicine.

Most Americans agree with Dr. Collins. A recent survey released by the Center for Medicine in the Public Interest found that nearly 90 percent of all Americans support the Critical Path Initiative and the development of biomarkers. But the congresswoman’s attack on the FDA reflects poorly on both her political and scientific judgment. The FDA cannot meet its responsibilities if it has to protect itself from politicians like Rep. Rosa DeLauro.

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