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`Inadequacies' at U.S. FDA Risk Lives, Report Says (Update5)

By Justin Blum

Nov. 29 (Bloomberg) -- American lives are at risk because the U.S. Food and Drug Administration lacks the funding to keep up with scientific advances, agency advisers said.

The FDA suffers from a ``plethora of inadequacies,'' including an ``appallingly low'' rate of food inspections and a lack of scientists who understand new technologies, a subcommittee of an outside panel said in the report, posted today on the agency's Web site. The full panel, known as the Science Board, will discuss the findings on Dec. 3.

The group said the FDA needs more money and better computer systems, and should be restructured to include a scientific leader. The agency, with a budget of more than $2 billion, regulates the sale of more than $1 trillion of products annually, including food, drugs, cosmetics and medical devices.

``Without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public,'' according to the report, by three members of the board. ``This will damage not only the health of the population of the U.S., but also the health of our economy.''

The report describes rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and says the FDA can't adequately monitor products because it can't keep up with the science. The FDA suffers ``serious scientific deficiencies,'' the report concluded.

Science Leader, Computers

Andrew von Eschenbach, the FDA's commissioner, requested the report a year ago. The Science Board formed a subcommittee that was headed by Gail H. Cassell, vice president of scientific affairs at Eli Lilly & Co. The subcommittee consulted more than 25 specialists in industry, academics and government.

The FDA ``values the thorough evaluation'' and will await a formal recommendation from the Science Board, which advises the commissioner, said agency spokeswoman Sandy Walsh in an e-mail.

In discussions with the subcommittee, FDA employees and officials were almost unanimous in saying there was a shortage of science staff and an ``inability to recruit and retain needed expertise,'' according to the report.

`Broken' Import System

There are insufficient inspections of manufacturers, a food supply that ``grows riskier each year,'' an inability to ``speed the development of new therapies,'' and a ``badly broken'' import system, according to the report.

The FDA has received an increasing number of reports of harmful side effects associated with prescription drugs over the past decade and has had no increase in staff to review them, the report said.

Managing crises has diverted resources from the agency's ability to develop its ``science base'' to support routine food surveillance and investigate outbreaks in an effort to protect the food supply.

Each American pays about 1 1/2 cents a day to fund the FDA, and an increase to 3 cents a day wouldn't ``be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world,'' according to the report. The agency receives federal funding along with fees paid by makers of drugs and medical devices.

The report blames Congress for requiring the FDA to take on more responsibilities without providing enough funding to hire staff.

More money is ``one component of what is necessary to help remedy the myriad problems the agency is facing,'' said Representative Rosa DeLauro, a Connecticut Democrat who leads a House panel responsible for FDA funding, in a statement. The House, in pending legislation, has approved additional funding that the agency never requested, she said.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.

Last Updated: November 29, 2007 17:28 EST

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