FDA Criticized

FDA Criticized

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Advisers Say F.D.A.’s Flaws Put Lives at Risk
By GARDINER HARRIS

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 du

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