President’s Proposed Budget Increases Funding for FDA and its Device Office

It is that time of year again. With Republicans in control of the House, Democrats in control (though by narrow margin) of Senate and, of course, the White House, prepare for non-stop wrangling over the budget for the government’s 2012 fiscal year, which runs from Oct 1 this year through Sept. 30.

As part of the budget request that was sent to Congress on Feb. 14, the Obama administration has requested $329 million in appropriations for the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH)—a 4.8 percent increase over current appropriation levels for CDRH.

For fiscal year 2012, the overall budget request for the FDA is $4.4 billion, a net program-level increase of $1 billion, or 33 percent, compared with FY 2010. The 2012 budget proposal includes increased investments to implement the FDA Food Safety Modernization Act, advance medical countermeasures, and improve drug and device safety. The release of the President’s proposed budget is the first step in the budget process as spending and revenue measures are considered by Congress.

FDA’s budget is included under the budget for the U.S. Department of Health and Human Services (HHS). Approximately 84 percent of the $892 billion in outlays for the FY 2012 budget proposal for HHS is allocated to entitlement programs, 54 percent for Medicare and 30 percent for Medicaid.

The proposed FY 2012 HHS budget also includes $32 billion for the National Institutes of Health, which represents an increase of $745 million compared with the FY 2010 enacted level, to support basic and clinical research. In FY 2012, NIH estimates that it will support a total of 36,852 research project grants, including 9158 new and competing awards. In FY 2012, NIH plans to establish the National Center for Advancing Translational Sciences (NCATS) as a mechanism for bridging the gap between basic science and therapeutic applications. With the creation of NCATS, the National Center for Research Resources will be abolished, and its programs will be transferred to the new center or other parts of NIH.

Dr. Margaret Hamburg, head of the FDA, defended the funding increase, calling it “crucial to the modernization” of the agency, which regulates nearly 20 percent of all products purchased and consumed in the U.S. Hamburg used similar rhetoric to back up the 2012 request.

“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,” Hamburg said in prepared remarks.

The final version of these numbers undoubtedly will change dramatically before the budget process is finished.