FDA FISCAL 2006 BUDGET SET AT $1.8 BILLION
The full Senate has approved an agriculture spending bill that sets the FDA's fiscal 2006 budget at $1.841 billion -- slightly more than what the House approved in June.
Under the Senate bill, the FDA's proposed budget is nearly $65 million more than the fiscal 2005 level, and includes an increase of nearly $21 million in prescription drug user fees. The FDA's budget is set by the fiscal 2006 agriculture appropriations bill, H.R. 2744, which the Senate recently approved by a 97-2 vote.
Among other things, the Senate spending bill would allocate $515.4 million, including industry user fees, to the FDA's Center for Drug Evaluation and Research (CDER), and $178.7 million, including user fees, to the agency's Center for Biologics Evaluation and Research (CBER). The bill also includes an additional $5 million for drug-safety activities.
The House appropriations bill contains similar FDA funding levels. The FDA's fiscal 2006 budget would be set at $1.837 billion under the spending proposal approved by the House by a 408-18 vote June 8 CDER would be funded at $519.8 million and CBER at $178.7 million. The House also approved an additional $5 million for drug-safety initiatives.
Under the House bill, the FDA's Office of Drug Safety (ODS) would receive $22.9 million, with the additional $5 million for the program to be used on "the highest priority drug-safety needs," according to details of the budget provided to FDAnews by the Senate Health, Education, Labor and Pensions (HELP) Committee.
Within 30 days of enacting the budget legislation, the House would direct the FDA to provide a detailed spending plan for these additional funds and other ODS funds, according to the HELP Committee. The House also expects to receive quarterly reports providing details about the FDA's planned changes for drug safety, including review processes or reprogramming and plans for external review. The House also wants reports on other new FDA safety initiatives, including education efforts or labeling changes, and the result of the Institute of Medicine study on drug-safety issues.
Meanwhile, the Senate legislation also requests a report on the FDA's efforts in drug safety as part of the additional $5 million, including those related to orphan products. In addition, the Senate provides $750,000 to support collaborative research -- with the Critical Path Institute and the University of Utah -- on "cardiovascular biomarkers predictive of safety and clinical outcomes."