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FDA's science infrastructure failing.

TWO DECADES OF INADEQUATE funding have rendered the Food and Drug Administration’s (FDA’s) scientific capacity insufficient to meet the growing demands of ensuring the public’s health and safety, according to a report issued in December by an advisory group to the agency. Advances in science, greater complexity in the products it regulates, and globalization of FDA-regulated industries are among the trends placing unprecedented demands on the FDA, yet resources for the agency’s science infrastructure and staff have been stagnant, according to the 300-page report (http: //www.fda.gov/ohrms/dockets/ac/07 /briefing/2007-4329b_02_01_FDA %20Report%20on%20Science%20and %20Technology.pdf). The report was published by a subcommittee of the FDA Science Board, which advises FDA Commissioner Andrew C. von Eschenbach, MD, and convened the subcommittee at his request. The report, which took 1 year to complete and drew on the expertise of 3 board members and 30 outside experts, was presented to and endorsed by the Science Board on December 3. During the period between 1988 and 2007, the US Congress enacted more than 125 statutes related to the FDA’s regulatory responsibilities. But due to inflation, the purchasing power of the agency’s appropriations decreased by $300 million during the same period and the agency’s staff increased by only 9% (646 new staff positions), according to the report. The subcommittee identified 3 key weaknesses in the FDA that have emerged as a result of such gross underinvestment: a weak scientific organizational structure, an insufficient science workforce, and outdated information technology systems. These vulnerabilities have left the agency unable to fulfill its duties, placing the public at risk from unsafe foods or medical products, according to the report. Examples of problems interfering with the agency conducting its duties include failure of the FDA’s e-mail system during an investigation of an Escherichia coli outbreak and difficulties accessing valuable clinical trial data warehoused as paper copies. “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,” according to the report. “Today, not only can the Agency not lead, it cannot even keep up with the advances in science.” Correcting these deficiencies will require substantial new investment in the agency. The subcommittee estimates that each US individual currently pays about a penny and half each day for the FDA and at least double that would be reasonable, considering the importance of the services that the agency offers. Although the committee did not offer a total figure, this would amount to an annual appropriation of approximately $3.2 billion per year based on the $1.6 billion appropriated for the agency in 2007. At a December 4 press conference sponsored by the Coalition for a Stronger FDA and FDA Alliance, 2 nonprofit organizations that lobby for greater funding for the agency, subcommittee members referred to these organizations for more specific FDA funding proposals. The Coalition for a Stronger FDA has advocated an annual increase of 15%, or $225 million, in the agency’s budget over several years, an amount the subcommittee concluded in its report would be insufficient. The FDA Alliance has proposed a $2 billion annual budget