FDA Report Calls for More Funding, Staff, Technology
FDA lacks adequate funds and staff to ensure public safety, according to a report from a three-member subcommittee of the Science Board published Thursday on the agency Web site, Bloomberg/Washington Post reports.
For the report, which FDA Commissioner Andrew von Eschenbach requested last year, the subcommittee -- chaired by Gail Cassell, vice president of scientific affairs at Eli Lilly -- consulted more than 25 experts in industry, academia and government (Blum, Bloomberg/Washington Post, 11/30). The subcommittee also included Allen Roses, a neurology expert at Duke University, and Barbara McNeil, a public health policy expert at Harvard Medical School (Schmitt, USA Today, 12/3).
The report cited a "plethora of inadequacies," such as an "appallingly low" rate of food inspections, a lack of scientists who understand new technologies and an "inability to recruit and retain needed expertise." In addition, the report cited inadequate inspections of manufacturers, an inability to "speed the development of new therapies" and a "badly broken" import system. FDA also requires additional funds and improved computer systems, as well as a scientific leader, according to the report.
The report said, "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," adding, "This will damage not only the health of the population of the U.S. but also the health of our economy." According to the report, Congress has required FDA to assume more responsibilities but has not provided adequate funds. The full Science Board plans to discuss the report on Monday.
FDA "values the thorough evaluation" and will wait for a formal recommendation from the Science Board, agency spokesperson Sandy Walsh said in an e-mail.
Rep. Rosa DeLauro (D-Conn.) said that additional funds represent "one component of what is necessary to help remedy the myriad problems the agency is facing" (Bloomberg/Washington Post, 11/30).
McNeil said, "This was the first time that a group of people got together and really looked at all the areas that the FDA has to cover," adding, "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 FDA had to work under" (Harris, New York Times, 12/1).