The government agency that regulates virtually all of the foods and drugs Americans use is stretched too thin and shackled by too much red tape to do its job correctly, a federal advisory panel reported Wednesday.
It said the Food and Drug Administration needs more power, money and status within the federal bureaucracy to ensure it can protect public health.But the 15-member advisory panel said it would be unrealistic to expect that the FDA would receive a massive infusion of new money and stressed the agency's need to set priorities, streamline operations and improve management.
Sen. Edward Kennedy, D-Mass., said the report shows "we are living too close to the edge."
"Each time confidence in the agency is eroded and FDA staff become more demoralized, the nation moves close to the very real possibility of a major health disaster," he said.
Kennedy's Senate Labor and Human Resources Committee was holding a hearing on the report Wednesday.
The FDA had no immediate comment on the report.
The report said that while there is no evidence the FDA's problems have threatened public health, "there is genuine concern that if these problems are not squarely addressed, the agency will be unable to fulfill its vastly increased and critically important responsibilities in the future."
The report is the result of a yearlong study by the Advisory Committee on the Food and Drug Administration, established by the Department of Health and Human Services because of a growing perception of an FDA in crisis.
FDA was severely shaken in 1989 by a generic-drug scandal that led to payoff scheme convictions for both agency employees and drug company officials.
The advisory committee said it began its work "with shared doubts about the FDA's ability" to do its job. And it said those doubts were reinforced by witnesses who depicted the agency as "overextended, underfunded and shackled by bureaucratic constraints."
The panel included medical, pharmaceutical and legal experts. It was chaired by Dr. Charles C. Edwards, a former FDA commissioner.