Saturday, December 1, 2007

FDA - An Agency in Crisis

One year ago, the Commissioner of the US Food and Drug Administration directed the agency's Science Board to review whether the FDA had the necessary personnel, science expertise, equipment and budget to carry out its various mandates effectively. The results of that review have just been made public.

The findings reported by the Science Board are shocking, but not surprising to anyone who has followed the deteriorating state of our food safety systems these last several years. Among its series of observations, the Board had this to say about the current state of the FDA (and these are direct quotes):
  • The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
  • The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
  • The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
  • FDA does not have the capacity to ensure the safety of food for the nation.
Peter Barton Hutt, a former FDA Commissioner and a contributor to this report, observes that the FDA has been underfunded for decades, and faults both Democratic and Republican administrations for piling additional unfunded mandates onto the agencies plate. In Hutt's opinion, the FDA needs a doubling of its current budget and a 50% increase in manpower to begin to address its deficiencies.

The budget shortfalls and resultant lack of equipment, resources and personnel to carry out FDA's responsibilities have also seriously damaged the morale of agency personnel. This, in turn, has accelerated the loss of trained scientists and administrators - many of whom are difficult to replace.

While all parts of the agency are hurting, the two most seriously affected appear to be the Center for Food Safety and Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM). The Board observes in its report that a simple lack of resources prevented the FDA from timely introduction and enforcement of new animal feed regulations to prevent the spread of mad cow disease in the United States. And even in the face of the recent pet food recalls, the CVM can only afford to have two people working on pet food issues.

The Food and Drug Administration once was one of the most respected agencies of the US government. In the 1970s, approximately 80% of Americans surveyed expressed confidence in the agency. That level of confidence has deteriorated (to 36% in 2006) along with the capabilities of the FDA to manage all of the statues that fall into its areas of responsibility.

Finally, the Science Board observes that "(r)ecommendations of excellent FDA reviews are seldom followed," and that failure to act on past recommendations "...has jeopardized the public's health." Let's hope that, this time, someone is listening.

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