Friday, November 30, 2007

FDA Needs More Money and Staff, Report Finds
By Justin Blum
Bloomberg News

American lives are at risk because the 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 a report posted yesterday on the agency's Web site. The full panel, known as the Science Board, will discuss the findings Monday.

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," said 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."

FDA Commissioner Andrew von Eschenbach 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 . The subcommittee consulted more than 25 specialists in industry, academia and government.

The FDA "values the thorough evaluation" and will await a formal recommendation from the Science Board, which advises the commissioner, agency spokeswoman said 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.

The report also cited what it called 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.

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," Rep. Rosa DeLauro (D-Conn.), who leads a House panel responsible for FDA funding, said in a statement. The House, in pending legislation, has approved additional funding that the agency never requested, she said.

Robert Califf, MD, Vice Chancellor for Clinical Research at Duke and the Director of the Duke Translational Medicine Institute, was one of the authors on the study.