NEW YORK (GenomeWeb News) – The White House plans to ask Congress for an extra $275 million to help give the US Food and Drug Administration the tools, talent, science, and infrastructure it needs to keep up with biomedical advances, Department of Health and Human Services Director Michael Leavitt said yesterday.
Much of the new funding would be tabbed for food and drug regulation needs, particularly for enhanced inspections and testing in the US and abroad, but $50 million would go to modernizing the FDA’s science and workforce, which would include strengthening the FDA’s ability to support safety and development in emerging sciences.
Specifically, this modernization program would be based on a two-pronged plan, including investments that would support science-based regulation and to fund science leadership and coordination.
The program would provide $27 million to strengthen the agency’s capacity to support new technologies such as genomics, proteomics, Critical Path initiatives, cell and gene therapies, and other capabilities. Another $5 million would go to strengthen and integrate programs in emerging science at the National Center for Toxicological Research and at other centers.
The science-based regulation program would include $4 million for science training and professional development, $4 million to launch a Science Fellow Program and to recruit the first 500 fellows, and $10 million to improve facilities outside of the Washington, DC, area in order to enable the facilities to use new medical products and food technologies.
The FDA also wants to spend $100 million to improve the agency’s medical and drug programs, which would include more aggressive safety surveillance of adverse events linked to medical products, and would establish device identifiers that can help track devices, facilitate recalls of devices, and support management of inventories during disasters and in response to terrorism events.
A large part of the additional funds — $125 million — would be directed to expenses related to protecting the US food supply.
Just six months ago the FDA issued a report that described the agency’s condition as dire, and described an organization that “cannot fulfill its mission” in part “because its scientific workforce does not have sufficient capacity and capability.
According to that report, the FDA's problems stem from stagnant funding, the globalization of both the medical and food industries, and advances in genomics and pharmacogenomics in the biomedical sciences.
One action the FDA Science Board’s report advised as a way to catch up with science would be to create a formal Genomics Program, because the “continued absence of an organized structure may lead to difficulties in staff recruitment and retention.” The board also advised the FDA to establish a genomics core laboratory at the White Oak research lab in Maryland, which would be staffed with around 80 full-time scientists and other staff who would have expertise in expression profiling, sequencing, informatics, proteomics, metabolomics, and systems biology.
As GenomeWeb Daily News reported in February, in the White House’s proposed fiscal 2009 spending plan, the administration stated that “recent advances in genomics, proteomics, computational biology, and many other fields of science,” are giving researchers tools that will allow them a broader understanding of disease “years before it strikes the patient.”
The White House requested $2.4 billion for the FDA in total program level spending, compared with $2.17 billion in fiscal 2008. The extra funds announced today would raise the FDA’s budget for the coming year by around $400 million compared to fiscal 2008.
The new funds also would be used to support a number of planned import safety initiatives, including one authorizing the agency to accredit third parties to evaluate FDA compliance requirements, and one that would require certification of products that are designated as high-risk.