BUSINESS NEWS

In February, the Bush ad-ministration announced a proposed FDA budget of $2.4 billion for the 2009 fiscal year. Under the president's proposal, FDA's Center for Devices and Radiological Health (CDRH) would receive $290.9 million—an increase of 2.5% over FY08.

Commenting on the proposed funding for FDA's medtech-related activities, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, says, "CDRH doesn't do so well in this budget. Nobody does, but CDRH does particularly poorly."

Although many advocacy groups joined the alliance in taking a hard-line position on the proposal, the leading medtech industry associations—which are both alliance members—offered more-measured responses. Stephen J. Ubl, president and CEO of AdvaMed (Washington, DC), said, "While this additional funding is a good start, the FDA could benefit from additional increases in appropriations to better prepare for the future and to perform its core functions."

Mark Leahey, executive director of the Medical Device Manufacturers Association (Washington, DC), said, "While we believe that CDRH could definitely use more evaluators to review submissions, we do not especially see FDA's device-sector needs as perhaps as pressing as what appear to be legitimate concerns regarding FDA's oversight activities involving food, drugs, and other areas."

Many agency observers agree that FDA's mission and scope have significantly expanded over the past 25 years. Thus, some argue that the agency should receive increased funding from Congress rather than increased user fees. Failing additional appropriations, some contend that the agency's mission should be modified or scaled back.

Glen Paul Freiberg, president of RCQ Consulting (Rancho Santa Fe, CA) contends that the agency needs to set limits on its demands for new resources. "FDA needs to adopt more business-oriented analysis methods, particularly with regard to the application of resources to perform its primary mission--that is, determining, prioritizing, and differentiating what it needs to do rather than what would be nice to do," he says.

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