Lawmakers say budget underfunds FDA

Four senior House Democrats have asked an advisory group that recently warned of the consequences of long-term underfunding of the Food and Drug Administration to evaluate the Bush administration's fiscal 2009 budget to determine if it would provide adequate resources for the agency.Bush requested $1.7 billion for FDA, up from $1.4 billion this year. With $628 million in industry user fees, the 2009 total for FDA would be $2.4 billion. FDA is part of the Health and Human Services Department. The agency is so chronically underfunded that it does not have the science foundation, staff or information technology to meet mounting the demands of overseeing the nation’s food, drug and medical device safety, the Science and Technology Subcommittee of the FDA Science Board said in a report in November.In a letter sent Feb. 4, the Democratic lawmakers said they were concerned that the budget is “grossly inadequate” to meet the challenges that the advisory board identified. The letter was signed by Reps. Henry Waxman (D-Calif.), chairman of the Oversight and Government Reform Committee; John Dingell (D-Mich.), chairman of the Energy and Commerce Committee; Frank Pallone Jr. (D-N.J.), chairman of the committee’s Health Subcommittee; and Bart Stupak (D-Mich.), chairman of the committee’s Oversight and Investigations Subcommittee.“It barely covers the cost of inflation and continues the trend of the inadequate budgets of previous years that have led to the current crisis at the agency,” the lawmakers said in the letter to Gail Cassell, former chairwoman of the Science Board’s subcommittee. “We want to ensure that funding for FDA is sufficient to permit the agency to fulfill its many regulatory responsibilities.”They also requested that the advisory group provide the specific funding levels necessary to remedy FDA’s deficiencies. Although the science and technology group has since disbanded, the lawmakers asked that Cassell convene any members who are availableLast week, Waxman and Sen. Edward Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pensions Committee, requested that the Government Accountability Office examine FDA’s resource shortfalls and their effect on staffing and IT.The 2009 budget proposal would provide increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices, FDA Commissioner Dr. Andrew von Eschenbach said in his budget announcement Feb. 4. FDA would also be able to hire more than 500 additional employees.The advisory board report said the country’s food supply and the regulatory systems that oversee drug and device supplies were at risk and that the situation was the result of soaring demands on FDA without a proportionate increase in resources.“This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public,” the board members said in the report.Von Eschenbach said the budget would support new drug and medical device safety programs established by the FDA Amendments Act that became law last year, which are funded by user fees.Among FDA’s proposed spending for IT, the budget would provide $16.8 million for information and computer technologies, $9.7 million for its MedWatch Plus adverse event reporting system and $11.2 million for its Mission Accomplishment and Regulatory Compliance Services, which seeks to integrate existing systems into one program.