US legislators have called for immediate action by the federal government after a panel of Food and Drug Administration advisors warned that financial and resources shortfalls at the agency are now putting American lives at risk and that the agency has been reduced to “management by crisis.”
Demands on the FDA have soared but resources have not increased proportionately, and this is imposing a significant risk to public safety, says the report, which has been produced by a subcommittee of the FDA’s advisory Science Board at the request of FDA Commissioner Andrew von Eschenbach. Continual expansion of FDA responsibilities coupled with a dramatic decline in resources represents a “very dangerous trend,” warn the authors.
“The world looks to the FDA as a leader – to integrate emerging understandings of biology with medicine, technology and computational mathematics in ways that will lead to successful disease therapies,” says the committee. However, it says, the reality is that: “today, not only can the agency not lead, it cannot even keep up with the advances in science.”
“Substantial weaknesses” exist across the agency, with the possible exception of some drug and medical device review functions funded by industry user fees, say the advisers. Resource shortfalls have resulted in “a plethora of inadequacies that threaten our society,” including: inadequate inspections of manufacturers, a dearth of scientists who understand emerging new technologies, an inability to speed the development of new therapies, an import system that is badly broken, a food supply that grows riskier each year and an information infrastructure that was identified as a source of risk in every Center and programme reviewed by the panel.
“We conclude that FDA can no longer fulfill its mission without substantial and sustained additional appropriations,” say the advisers, and they warn that if these gaps are not addressed immediately, FDA is in jeopardy of losing its remaining dedicated staff. “The extraordinary efforts of these committed FDA staff members are the very reason further catastrophic food and drug events have been averted,” they comment.
The subcommittee further warns that the severe loss of scientific capacity at the agency also threatens “the viability of the industries FDA regulates, the speed of medical innovation and the security of our nation.”
While the changes that are necessary will require a phased approach based on a well-thought-out plan, immediate commitment is needed to make the necessary investments in order to recruit the most outstanding talent, the advisers say. In its own examination of the agency earlier this year, the Institute of Medicine said that the minimum immediate appropriation necessary to address urgent drug safety needs is $350 million, while other groups, such as the Coalition for a Stronger FDA, believe an annual 15% increase over the next five years is required. However, the subcommittee believes these measures would be insufficient.
“Currently, each American pays about a penny and a half a day for the FDA; an increase to three cents daily would not, in our view, be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world,” the advisors conclude.
The FDA declined to comment on the report, but Edward Kennedy, chairman of the Senate Health, Education, Labor and Pensions Committee, described it as “a wake-up call that our citizens are being placed at great risk every single day that it fails to provide the FDA with the resources to do its job.” Moreover, he said, failure to fund the FDA will cost America in terms of reduced competitiveness and lost jobs.
Henry Waxman, chairman of the House Committee on Oversight and Government Reform, said he has written to Commissioner von Eschenbach, Health and Human Services Secretary Mike Leavitt and Jim Nussle, director of the Office of Management and Budget, urging them to ensure the agency receives sufficient funding and resources to carry out its tasks. The subcommittee report “paints a dire picture of a chronically underfunded public health agency” and reveals that the FDA’s scientific capacity “has been so eroded that it can no longer fulfill a frightening number of critical regulatory and public health responsibilities,” he tells the officials.
Waxman slams off-label drug promo plans
Meantime, Rep Waxman has also written to Commissioner von Eschenbach urging him not to proceed with proposals to allow drug companies to use journal articles to promote “potentially dangerous” uses of drugs and medical devices without prior FDA review and approval.
Rep Waxman says he has obtained a copy of an internal draft of the new guidance which, he says he believes the agency plans to issue without significant changes in the very near future. However, he warns the Commissioner that the draft guidance “would carve a large loophole in the law” and would, in effect, allow manufacturers to “short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns. This undercuts the prohibition on marketing of unapproved uses of drugs and devices and puts the public at risk for ineffective and dangerous uses of drugs,” he says.
The House panel will be conducting an enquiry into the draft guidance and the process that led to its development, Rep Waxman tells Commissioner von Eschenbach, adding: “I hope you will cooperate.”
