Healthy Skepticism Library item: 12093

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Publication type: news

Harris G.
Advisers Say F.D.A.’s Flaws Put Lives at Risk
New York Times 2007 Dec 1
http://www.nytimes.com/2007/12/01/washington/01fda.html?_r=3&th=&adxnnl=1&oref=slogin&emc=th&adxnnlx=1196514155-yrpd2FxUV18JPLsHEtnRIg&oref=slogin&oref=slogin

Full text:

WASHINGTON, Nov. 30 – The nation’s food supply is at risk, its drugs are potentially dangerous and its citizens’ lives are at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to an alarming report by agency advisers.

The report, made public on Friday, is the latest and perhaps most far-reaching in a string of outside assessments that have concluded that the F.D.A. is poorly equipped to protect the public health.

It was written by three members of the F.D.A. Science Board, an advisory panel that reports directly to the agency’s commissioner, Dr. Andrew C. von Eschenbach. The three authors in turn had 30 scientific advisers.

The report concludes that over the last two decades, the agency’s public health responsibilities have soared while its appropriations have barely budged. The result is that the F.D.A. is falling farther and farther behind in carrying out its responsibilities and understanding the science it needs to do its many jobs.

“F.D.A.’s inability to keep up with scientific advances means that American lives are at risk,” the report stated.

Sandy Walsh of the F.D.A. said the agency “values the evaluation done by the subcommittee members and the scientific experts that were consulted” but would not comment further.

Barbara J. McNeil, a professor of health care policy at Harvard Medical School and one of the report’s authors, said she was stunned at the agency’s sorry state.

“This was the first time that a group of people got together and really looked at all the areas that the F.D.A. has to cover,” Dr. McNeil said. “We were shocked at the scope of its responsibilities, we were shocked at how little its resources have increased, and we were surprised at the conditions those in the F.D.A. had to work under.”

The report notes that the agency’s computer systems are aging and prone to breakdowns, “most recently during an E. coli food contamination investigation.”

“Reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems,” the report stated.

The agency often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.

The Institute of Medicine, the nation’s most prestigious scientific advisory organization, concluded last year that the agency’s system for ensuring the safety of drugs needed an overhaul. Recent legislation enacted some of the institute’s recommendations.

More hearings regarding the F.D.A.’s oversight of food are in the offing, including one in the Senate on Tuesday. The report concluded that the “F.D.A.’s ability to provide its basic food system inspection, enforcement and rule-making functions is severely eroded, as is its ability to respond to outbreaks in a timely manner.”

Garret A. FitzGerald, a pharmacologist from the University of Pennsylvania and adviser to the authors, said the report was raising an alarm because “this is a crisis.” Dr. FitzGerald pointed to a series of food and drug scares that have demonstrated how little oversight the F.D.A. provides.

He blamed a “cabal of Congressional majorities and presidential administrations that has serially stripped the agency of assets.”