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FDA Sees 2012 Budget Buoyed by Fees

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration expects the increase in funding of $382 million called for in the White House's 2012 budget proposal will be bolstered by increases in user fees to fund its existing activities and new programs.

In the budget request, which President Barack Obama submitted to Congress Monday, the FDA proposed that it receive a budget authority of $2.74 billion, up from $2.37 million in fiscal 2010, and it said it expects new revenue from changes to user fee policies to add another $1.62 billion for the year.

That would bring its total budget to $4.36 billion, a 33 percent increase over its total 2010 budget, which would fund some new programs that use genomics, pharmacogenomics, and other molecular biology tools to achieve its goals.

"FDA protects and promotes the health of all Americans through every stage of life," FDA Commissioner Margaret Hamburg said in a statement Monday.

"The breadth of this mandate means that FDA responsibilities continue to grow. The new budget contains new resources so that FDA can fulfill its growing responsibilities to the American public," she continued.

These new FDA efforts include the $324 million Transforming Food Safety and Nutrition Initiative; $70 million for the Advancing Medical Countermeasures Initiative; $124 million for the Protecting Patients Initiative; and $49 million for the Regulatory Science and Facilities Initiative.

In the proposal, the Center for Devices and Radiological Health budget would rise from $313.9 million to $320.5 million. Funding for the National Center for Toxicological Research would remain nearly flat at $49.1 million, even though that center will take on many initiatives tied to personalized medicine and genomics-related efforts.

FDA plans several Regulatory Science and Facilities initiatives. One such measure will start a national Medical Device Registry that will link unique identifiers for medical devices and electronic health data.

Other efforts will include steps to develop and articulate "clear regulatory standards" for products using genomics, systems biology, proteomics, nanotechnology, and other new, fast-developing technologies.

"In order to develop regulatory standards for cutting-edge technologies, FDA must conduct research and provide input to external groups that seek to develop, for example, new biomarkers or biosimilar products, also known as follow-on proteins or follow-on biologics," the agency said in its budget proposal report.

"The investment in regulatory science will benefit new product development in areas such as personalized medicine and systems biology – including genomics," said FDA.

NCTR will continue its focus on three program areas, including personalized nutrition and medicine, surveillance and risk analysis, and enhancing the safety of medical products.

The Personalized Nutrition and Medicine program will seek to undertake research strategies to identify genetic, environmental, and cultural diversity factors that affect health and disease. NCTR will focus some efforts on characterizing biomarkers that will enable FDA to identify science-based therapies that will increase the effectiveness of treatments, and to reduce the rate of adverse events in patients. FDA said that NCTR also will explore new approaches in the personalized health and medicine areas such as nutrigenomics.

NCTR will continue to support its Genomics Laboratory for analyzing and re-sequencing human and primate genes and studying how individual variants are linked to biological response, particularly in the area of drug metabolism.

"Establishing expertise in the area of genomics is essential for FDA's regulatory mission to enable evaluation of new products and services that are developed on the basis of genomic information," FDA said.

Also at NCTR, the Genomic KnowledgeBase program will continue to develop pharmacogenomic knowledge that was discovered using the Array Track integrated DNA microarray data management, mining, analysis, and interpretation software program.

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