Healthy Skepticism Library item: 12094

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Publication type: news

Panel says FDA losses jeopardize public
Associated Press 2007 Nov 30
http://www.nj.com/newsflash/washington/index.ssf?/base/politics-14/119648218241120.xml&storylist=washington

Full text:

WASHINGTON (AP) – A loss of scientific expertise at the Food and Drug Administration is threatening American lives, advisers to the embattled consumer protection agency conclude in a report released Friday.

Food safety in particular is in crisis, concludes the nearly yearlong review by scientists from leading universities and industries the FDA regulates.

Scary headlines from recent years – heart-damaging drug side effects, deadly E. coli in spinach, pets dead from chemically spiked food, toxic toothpaste – have triggered growing questions about FDA’s ability to safeguard the public. Indeed, the new report is the latest in a list of outside reviews to conclude the cash-strapped FDA has trouble keeping pace with the $1 trillion worth of consumer goods it regulates.

FDA Commissioner Andrew von Eschenbach requested that the agency’s Science Board, his own outside advisers, probe the problems.

The Science Board subcommittee given the task was blunt: “In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events and our findings indicate that some of those crises are now realities and American lives are at risk.”

The Science Board will debate the new report at a meeting Monday.

Congress has enacted 125 statutes giving the FDA new or expanded responsibilities since 1988, without enough funding to cover the extra work, the report said. The FDA has about the same number of employees today as 15 years ago, and its budget has lost the equivalent of $300 million to inflation.

At the same time, increasingly sophisticated scientific expertise is required to oversee increasingly complex medical therapies and imported foods. The report found FDA is unable to recruit and retain leading-edge scientists in key areas and now has a turnover rate twice that of other government agencies.

The report cites an Institute of Medicine estimate that the $1.8 billion FDA budget needs a boost of at least $350 million to address drug safety, and a food industry appeal for $450 million more to improve food safety.

An FDA spokeswoman called the report preliminary and declined further comment Friday.

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On the Net:

Science Board subcommittee report: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html