FDA SEEKS INCREASES FOR CRITICAL PATH, DRUG SAFETY
The FDA wants to reassign $52.3 million from various agency programs in fiscal 2007 to help fund influenza pandemic preparedness efforts, drug safety, the Critical Path Initiative and other priorities, according to a high-ranking agency official.
Meanwhile, the FDA also seeks to increase its resources by obtaining congressional authority to charge industry for reinspections of manufacturing facilities, the agency said in its budget proposal.
Under the proposal, the FDA would increase pandemic preparedness funding by $30.49 million, drug safety by $3.96 million and Critical Path by $5.94 million over fiscal 2006 levels. Overall, the FDA's fiscal 2007 budget is set at $1.95 billion, an increase of nearly $71 million over the fiscal 2006 enacted level, the document states.
The FDA conducted an agency-wide review to determine, given limited funding, what its greatest priorities are, according to the budget document.
"Our agency leadership established criteria to evaluate [fiscal] 2007 budget priorities based on whether they generated high-yield returns and advanced these priorities," the document said. Specifically, the FDA will "reduce or eliminate lower priority work while redirecting staff and resources to higher priority activities." Funding for generic drug research, for example, would be reduced, along with funding for research lab scientists, according to the budget.
By contrast, the FDA will use proposed pandemic funding increases to develop and assess new technologies, advise manufacturers on new vaccines, monitor the safety and effectiveness of these vaccines, among other efforts.
The additional Critical Path funding will be used to improve the agency's partnerships with academics and the private sector and help ensure that new developments more rapidly make it to market. For example, in fiscal 2007, the FDA will support clinical trials to validate the use of positron emission tomography imaging as a surrogate endpoint for developing new cancer drugs.
The FDA has stressed the need to improve the drug pipeline. "There is continued stagnation" in new products due to "inadequate attention" by industry to new treatments because of too much focus on developing blockbusters, said Kathleen Heuer, the agency's associate commissioner, Office of Management and chief financial officer.