Members of the Senate say FDA's Food Protection Plan is not sufficient to improve the current U.S. food safety system, but an FDA advisory board says without additional resources "substantial weaknesses across the agency" will continue.

The Senate Committee on Health, Education, Labor and Pensions conducted a hearing Dec. 4 to discuss food safety and the Food Protection Plan proposed by FDA as well as the poor evaluation of the agency made by its Science Board's Subcommittee on Science and Technology.

The Science Board's "FDA Science and Mission at Risk" report asserts a lack of funding and other resources not only threatens food safety enforcement, but also FDA's scientific and technological capabilities.

"Lack of regulatory science is now impacting the development programs - not just FDA's ability to assess them, but actually the success of development," Janet Woodcock, FDA's chief medical officer and Center for Drug Evaluation and Research acting director, said at a Dec. 3 media briefing. "Uncertainties at the end of development programs are such that we have to go and ask for more data."

According to the report, FDA cannot fulfill its mission because its "scientific organizational structure is weak," and its "information technology infrastructure is inadequate."

The subcommittee's recommendations include creating the Incubator for Innovation in Regulatory and Information Sciences at FDA to help facilitate a scientific approach and factor in funding for the "new sciences portfolio."

The panel also recommended a board of scientific counselors for each FDA center, made up of outside representatives from different government agencies to review programs and policies.

However, the subcommittee also says none of its recommended programs can be implemented until FDA receives more resources.

"We recognize that adequate resources - human and financial - alone will not be sufficient to repair the deteriorating state of science at FDA, which is why we also recommend significant restructuring," the report says. "But without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public."

Subcommittee member and former FDA chief counsel Peter Barton Hutt said, "Only Congress can provide the money and people needed to restore FDA science to the level necessary."

At the HELP Committee hearing, Chairman Edward Kennedy, D-Mass., called the report "stark" and "shocking" while acknowledging FDA's limitations. "The plain truth is that FDA doesn't have the money to do its job," Kennedy said.

However, paying for the Food Protection Plan will not help, he added. It will allow FDA to "impose preventive controls only for foods that have repeatedly been associated with serious adverse health consequences or death. Essentially, this provision is a requirement that people be injured or even killed before the FDA can act," Kennedy said.

The plan is part of the report issued Nov. 6 by President Bush's Interagency Working Group to provide import safety suggestions (¹ Also see "Mandatory Food Recall Power For FDA Better Than Using Existing Authorities?" - Pink Sheet, 12 November, 2007., p. 6).

Sen. Mike Enzi, R-Wyo., said the United States has "the best food safety system in the world," but there is room for improvement. "We do have to consider whether new authorities are needed to respond to those problems that are not detected and corrected," Enzi said.

Health and Human Services Secretary Michael Leavitt said the current system "is not adequate for the future."

Leavitt told the committee to "implement this very comprehensive" plan, FDA will need additional resources that he expects will be in the president's fiscal 2009 budget request.

He added FDA needs mandatory recall authority as proposed in the plan in cases of firms refusing to comply with recall requests.

David Acheson, FDA's food safety director, said not having that authority will impede the agency's effectiveness. "In the last few years, there have been two or three issues, particularly in the pet food industry where companies have absolutely refused," he said.

Recalls, Safety In Legislation

Sen. Dick Durbin, D-Ill., and Rep. Rosa DeLauro, D-Conn., have introduced legislation, S. 1274/H.R. 2108, to give FDA mandatory recall power for adulterated food products. A bill introduced by Rep. Betty Sutton, D-Ohio, H.R. 2099, would give the agency the authority to mandate a recall of any product it regulates (² Also see "Flurry Of Food Safety Bills Hit Senate, House In Wake Of Pet Food Recall" - Pink Sheet, 7 May, 2007., p. 6).

Rep. John Dingell, D-Mich., a champion for food and import safety issues and chairman of the Energy and Commerce Committee, proposed a bill, H.R. 3610, that would require country of origin labeling on imported food products and impose user fees on importers as well as give FDA mandatory recall power.

Sens. Bob Casey, D-Pa., and Chuck Grassley, R-Iowa, on Dec. 5 introduced the EAT SAFE Act of 2007 - Ending Agricultural Threats: Safeguarding America's Food for Everyone - to address problems with smuggled food and agriculture products that pose risks.

The bill, S. 2418, would authorize $25 million for FDA and the Department of Agriculture to hire additional personnel to track smuggled food and monitor food defense, give FDA authority to collect user fees to cover certification costs and direct USDA and HHS to develop a way to share data collected on contaminants and authorize $3.5 million to establish a food safety education grant program.

DeLauro, a frequent food and import safety critic, also authored the Food Import Safety Act, H.R. 3937, to strengthen FDA by providing tools to ensure the safety of food imports and require other countries to meet U.S. import standards (³ 'The Tan Sheet' Oct. 29, 2007, In Brief).

Another Durbin bill, S. 2245, would create a food safety commission to review the U.S. food supply system and make recommendations (⁴ 'The Tan Sheet' Oct. 29, 2007, In Brief).

Legislation introduced by Rep. Frank Pallone, D-Mich., H.R. 3624, would authorize unannounced food safety inspections by FDA, give inspectors authority to impound food and give the agency responsibility to establish a program to ensure the safety of imports.

- Katie Stevenson (k.stevenson@elsevier.com)

Advisors Say FDA Funding Fails Science, Senators Pan Food Safety Plan

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