A special extramural subcommittee of the FDA Science Advisory Board submitted a scathing report on FDA resources, structure and activities in response to a request initiated by Commissioner Andrew Von Eschenbach. The November 2007 document “FDA Science and Mission at Risk” concluded that the “Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging responsibilities.” This is a serious indictment of a Federal agency regulating 25 cents of every consumer dollar spent in addition to serving a pivotal role in maintaining food security and protection from both terrorist and natural threats relating to the health of the nation.
The principal cause of widespread deficiencies was an imbalance between the scientific capability of the Agency to maintain safety and the provision of resources to respond to domestic and global challenges. An understanding of scientific principles associated with new technology is the basis of all rational decisions regarding the regulatory and surveillance mission of the FDA. The report noted that the Agency will “flounder and ultimately fail without a strong scientific foundation”.
Appropriate function of the FDA depends on three complementary areas of concentration. Applied research is required to fulfill the mission of regulation. The Committee observed that “the scientific base has eroded and the scientific organizational structure is weak” A complement of trained, innovative and motivated scientific staff represent the second component allowing the Agency to respond to routine oversight and emergencies. It was the opinion of the reviewers that the “scientific workforce does not have sufficient capacity and capability” The number of FDA scientists has remained essentially at the same level for 20 years. Recruitment and retention are compromised by inadequate salaries, resources and restrictions. Turnover rate at the FDA is twice the level of comparable government agencies. The Committee confirmed that the information technology infrastructure of the FDA is inadequate both with respect to internal communication and interaction with other agencies.
A serious finding was that the FDA “does not have the capacity to ensure the safety of food for the nation”. Rulemaking, inspection and enforcement are woefully inadequate especially in the Center for Food Safety and Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM) both of which have an impact on poultry and livestock production and consumption. Deficiencies within these Centers are compounded by a lack of coordination and a crisis approach to constantly emerging challenges such as Bovine Spongiform Encephalopathy (BSE), Salmonella enteritidis (SE), and E coli O157.
Recommendations by the Committee reflect similar previous proposals by prestigious national organizations which have not been implemented. The current suggestions include restructuring of the FDA with leadership provided by a new position of Chief Scientific Officer. Increasing funding beyond the proposed $2.1 billion requested for FY 2008 is clearly indicated. Developing a science-based regulatory system applying existing and emerging technology will be necessary. A culture must emerge within the FDA which empowers qualified scientists to pursue basic and applied aspects of regulatory analytical and diagnostic activities. Cooperation must be encouraged with agencies such as the USDA-ARS, CDC, NIH and the Department of Homeland Security to carry out jointly funded task-oriented projects under the management of the National Science Foundation.
It is apparent that the FDA is under funded and lacks material and human resources especially in the area of applied science. Whether this is due to failure of the Executive Branch to provide an impetus for change or the lack of vision of successive FDA Administrators is the subject of conjecture. If the FDA has failed to present and motivate budgetary requests or has indulged in political partisanship in oversight impeding the mission of the Agency, the citizens of this nation have been shortchanged. If Congress has failed to respond to reasonable and justified requests for funding, the health and security of consumers has been placed at risk. There is no point in seeking culprits. Given the analysis and counsel of a wise and knowledgeable panel the Administration, Congress and the stewards of the Agency should develop programs to resolve problems.