Experts, Lawmakers Call for Increased FDA Funding To Address Agency Problems
FDA lacks adequate funds and organization to meet an increased number of responsibilities and ensure public health, witnesses and lawmakers said on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, CQ HealthBeat reports. During the hearing, lawmakers heard testimony from members of the FDA Science Board, which recently released a report that found "lives are at risk" because of problems at the agency.Peter Barton Hutt, an industry attorney and former FDA chief counsel who testified on behalf of the science board, said, "Science at FDA today is in a precarious position," adding, "The agency is barely hanging on by its finger tips." Hutt said that Congress should double funds for FDA over the next two years, increase the number of agency employees by 50% and provide an annual cost of living increase of 5.8% to all agency employees (Reichard, CQ HealthBeat, 1/29). According to Hutt, since 1988, more than 100 regulations have increased FDA responsibilities despite a lack of additional funds (Stark, McClatchy/Houston Chronicle, 1/30).
Gail Cassell, an Eli Lilly executive and chair of the science board, said, "We found that FDA's shortfalls have resulted in a plethora of inadequacies that threaten our society," such as "inadequate inspections of manufacturers; a dearth of scientists who understand emerging new technologies; inability to speed the development of new therapies; an import system that is badly broken; a food supply that grows riskier each year; and an information technology infrastructure that was identified as a source of risk in every (FDA) Center and program reviewed" by the board.
GAO Report
During the hearing, the Government Accountability Office released a report that found FDA cannot meet requirements to inspect medical device manufacturing facilities in the U.S. and abroad every two years. According to the report, FDA inspects U.S. facilities that manufacture the highest-risk medical devices once every three years and facilities that manufacture moderate-risk medical devices once every five years. FDA inspects facilities abroad that manufacture the highest-risk medical devices once every six years and facilities that manufacture moderate-risk medical devices once every 27 years, the report found (CQ HealthBeat, 1/29).
The report said, "FDA has opportunities to better leverage its resources," adding, "Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace." FDA requires "adequate authority, a clear purpose and timeframe, leadership support, an open process, a balanced membership, accountability and resources," according to the report (Mantell, Dow Jones, 1/30).
Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.) on Tuesday asked GAO to complete a review of the staff and other resources that FDA needs to address problems with oversight of food, medication, medical devices and safety, as well as information systems.
The GAO report is available online (.pdf).
FDA Commissioner Comments
FDA Commissioner Andrew von Eschenbach during the hearing said that he disagrees with the main conclusions of the report from the science board. He said, "It's not that it's bad" at FDA, "it's that it is at a level of excellence that needs to continue to improve and that needs to expand" (Edney, CongressDaily, 1/30). According to von Eschenbach, FDA has a strong "scientific base" that performs more effectively in efforts to ensure food safety than indicated by the report (Blum, Bloomberg/Arkansas Democrat-Gazette, 1/30).
However, von Eschenbach said that he takes the report "very seriously" and agreed to return in 60 days for a hearing on efforts by FDA to implement recommendations from the science board. He said that FDA has taken steps to implement some of the recommendations, such as the launch of a project to "totally modernize" information systems at the agency within two years (CQ HealthBeat, 1/29). Von Eschenbach added that he seeks to identify problems at FDA through a new food protection plan and later develop a business proposal to address the need for additional funds (CongressDaily, 1/30).
Von Eschenbach agreed that "FDA needs more resources," adding that he has "asked for those resources" from the Bush administration for the next budget, although he did not indicate whether the administration had agreed to the request (CQ HealthBeat, 1/29). The Bush administration likely will release a fiscal year 2009 budget proposal on Feb. 4 (Wilde Mathews, Wall Street Journal, 1/30).
