Witnesses: Broken F.D.A. puts public at risk

by Jay Sjerven
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WASHINGTON — A battery of witnesses on Jan. 29 testified before a congressional committee asserting the Food and Drug Administration lacked the resources and capacity to ensure the safety of the nation’s food and drug supply and that as a result the American public has been put at risk.

The hearing was convened by the House Committee on Energy and Commerce’s subcommittee on oversight and investigation under the chairmanship of Representative Bart Stupak of Michigan.

Five of the witnesses presenting testimony were members of a subcommittee of the F.D.A. Science Board established at the direction of Commissioner Andrew C. von Eschenbach in December 2006 to identify scientific and technological capacities the F.D.A. requires to fully support its core functions. The subcommittee’s findings were presented in its report, "F.D.A. Science and Mission at Risk," in December 2007.

Dr. Gail H. Cassell, vice-president, scientific affairs, Eli Lilly and Co., Indianapolis, who is a member of the F.D.A. Science Board and was chairperson of the board’s subcommittee, said, "What we found is quite simply, demands of F.D.A. have soared over the past two decades. Resources have not."

Ms. Cassell summarized her subcommittee’s principal findings, stating, "The F.D.A. cannot fulfill its mission because its scientific base has eroded and its scientific organization structure is weak. There is a fire-fighting regulatory posture instead of pursuing a culture of proactive regulatory science, especially related to food safety. Consequently, the nation’s food supply is at risk. The F.D.A. cannot fulfill its mission because its scientific workforce does not have sufficient capacity or capability. The F.D.A. cannot fulfill its mission because its information technology infrastructure is sorely inadequate. It is problematic at best and at worst it is dangerous."

Ms. Cassell added, "Although our subcommittee was asked to review gaps in scientific expertise and technology and not to assess available resources, it rapidly became apparent that it was impossible to assess gaps without also assessing resources. We concluded that F.D.A. can no longer fulfill its mission without substantial and sustained additional appropriations."

Peter Barton Hutt of the Washington, D.C., law firm of Covington & Burling L.L.P., asserted, "Science at the F.D.A. today is in a precarious position. In terms of both personnel and the money to support them, the agency is barely hanging on by its fingertips … The F.D.A. has become a paradigmatic example of the ‘hollow government’ syndrome — an agency with expanded responsibilities, stagnant resources, and the consequent inability to implement its statutory mandates."

Mr. Hutt indicated more than 100 statutes relating to the F.D.A. were enacted by Congress since 1988 and none of the statutes was accompanied by an appropriation of new personnel or increased funding to allow adequate implementation. "Instead, the agency is expected to implement all of these new unfunded congressional mandates with resources that, in the corresponding time, represent at best a flat budget," Mr. Hutt said. "Not surprisingly, many of the new congressional mandates languish for years or cannot be implemented at all."

Mr. Hutt pointed out, "The science functions within the F.D.A. Center for Food Safety and Applied Nutrition have been hit especially hard. In the 15 years from 1992 to 2007, CFSAN suffered a reduction in force of 138 people, or 15% of its staff." Deterioration of the F.D.A. field force has been equally severe, he added, pointing out between 1973 and 2006 there was a 78% reduction in food establishment inspections. "F.D.A. conducted twice the number of foreign and domestic food establishment inspections in 1973 (34,919) than it did for all F.D.A.-regulated products in 2006 (17,641)," he said.

"Congress must commit to a two-year appropriations program to increase F.D.A. employees by 50% and to double the F.D.A. funding, and then at least to maintain a fully burdened yearly cost-of-living increase of 5.8% across all segments of the agency," Mr. Hutt said. "Without these resources, the agency is powerless to improve its performance, will fall only further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public."

Lisa Shames, the director of natural resources and environment at the Government Accountability Office, said the F.D.A.’s Food Protection Plan issued last November contained positive first steps toward addressing the agency’s shortfalls but complained the F.D.A. has not provided specific information on the resources it anticipates will be needed to implement the plan. Ms. Shames said F.D.A. officials told the G.A.O. finalizing the amounts required will be part of the budget process. But Ms. Shames said, "Without a clear description of resources and strategies, it will be difficult for Congress to assess the likelihood of the plan’s success in achieving its intended results."

The issue of what resources were required to implement the Food Protection Plan and address the warnings of the F.D.A. Science Board also was the subject of vigorous questioning of Commissioner von Eschenbach by Representatives Stupak and John D. Dingell of Michigan, chairman of the Energy and Commerce Committee. They sought repeatedly without success to get Commissioner von Eschenbach to state what resources he requested of the administration, which is scheduled to release its fiscal 2009 budget this week. Commissioner von Eschenbach also declined to state whether or not he was satisfied with what he understands the president’s budget will contain for the F.D.A.

This article can also be found in the digital edition of Food Business News, February 5, 2008, starting on Page 1. Click here to search that archive.

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