Tuesday, December 4, 2007

American Lives are at risk

Congress has enacted 125 statutes giving the FDA new or expanded responsibilities since 1988, without any new funding to cover the extra work. HuffPo has the story.

An FDA advisory board concluded the situation is dire. "FDA's inability to keep up with scientific advances means that American lives are at risk," the report concluded. A report by the Institute of Medicine in 2006 reached the same conclusion, but the Republican-controlled Congress did nothing to improve the safety of the infant formula, pet food, toothpaste, spinich, prescription drugs and implants relied upon by millions of Americans.

In the wake of the scathing report detailing the dangerously poor state of the Food and Drug Administration, President Bush is threatening to veto much-needed funds for the agency.

Rep. Rosa DeLauro, D-CT, who leads the House panel responsible for FDA funding, called on President Bush to lift his objections to the agriculture appropriations bill, in which there is a drastic increase in money for the FDA. Without the infusion of cash, DeLauro said, U.S. consumers would be at great risk regarding food and drug safety.

The FDA Alliance and the Coalition for a Stronger FDA have issued a press release alerting us that the nation's food supply is at risk, as are the regulatory systems that oversee the nation's drug and device supplies, according to a subcommittee of the FDA's Science Board in a report it presented on December 3. They conclude that this imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public.

The result of a year-long review by a distinguished panel of experts, the 300-page report concludes that the state of FDA's scientific and regulatory programs could not be separated from the lack of resources available to support the agency's scientific base, hire and train a broadly-capable scientific workforce, and build a sophisticated and modern information technology infrastructure. You can find the report here.

FDA's need for recall authority here

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