FDA panel cites shortfalls in technology, staffing

The Food and Drug Administration faces shortfalls in staffing and information technology, which have resulted "in a plethora of inadequacies that threaten our society," according to a report by the agency's Science Board.

The board also concluded that "an information crisis is putting the FDA's mission at risk."

The report has not been publicly released by FDA, but is referenced in a letter to Comptroller General David M. Walker from Sen. Ted Kennedy, D-Mass., chairman of the Senate Health, Education, Labor and Pensions Committee; and Rep. Henry Waxman, D-Calif., chairman of the House Committee on Oversight and Government Reform. The two lawmakers are seeking an investigation into FDA's resource, staffing and budget shortfalls.

Kennedy and Waxman said they are concerned that FDA's budget hasn't kept pace with inflation and that a lack of skilled personnel hampers the agency's mission of regulating foods and critical medical devices such as pacemakers and hearing aids.

They also criticized the agency's IT infrastructure, which the Science Board called a "source of risk" at FDA's five centers: Biologics Evaluation and Research; Drug Evaluation and Research; Devices and Radiological Health; Food Safety and Applied Nutrition; and Veterinary Medicine.

Kennedy and Waxman said FDA "appears to have grossly inadequate resources to ensure the safety of imported foods as they come across the border. The agency is able to inspect less than 1 percent of food imports. Even as imports increase, the number of FDA inspectors has fallen since 2003." Approximately 15 percent of the U.S. food supply is imported, they said, but for some products such as fresh fruits and seafood, imports account for 50 percent to 60 percent of the supply.

FDA has estimated that illnesses from just 13 food-borne pathogens result in more than 13 million medical cases and cost $57 billion annually. This is only a fraction of the total cost, since these pathogens account for less than 20 percent of the nation's 76 million food-borne illnesses annually, Kennedy and Waxman said in their letter.

"Public confidence in the food supply has been so undermined that, for the first time, food industry trade associations are supporting resource increases for FDA and even new regulatory authorities," they added.

Kennedy and Waxman asked the Government Accountability Office to determine whether FDA's budget has kept pace with inflation and its increased responsibilities, and to assess staffing and user fees.

FDA's drug and medical device review programs are insufficiently supported by user fees, they said, asking GAO to analyze the drug and device budget, staffing and management oversight.

According to the Science Board report, Kennedy and Waxman said, FDA suffers from "critical capability gaps" because it has been unable to modernize its IT systems. They cited the following from the report:

  • FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
  • The agency cannot provide the information infrastructure support to regulate products based on new science.
  • IT infrastructure is obsolete, unstable and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.
  • The IT workforce is insufficient and not optimally organized.

In a related development, GAO released a report Tuesday that said two FDA databases on foreign medical device manufacturers contained inaccuracies and could not automatically exchange information.

Kennedy and Waxman asked GAO to conduct a throrough review of FDA's IT infrastructure so they can understand the deficiencies that impair the agency's ability to execute its mission.

"We are concerned that FDA has not been able to effectively modernize and use its IT systems to fulfill its mission needs," they said.

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