Earlier this month, the Bush administration announced a proposed FDA budget of $2.4 billion for the 2009 fiscal year. The administrations proposal represents an increase of $129.7 million, or 5.7%, above current funding. The request includes a $50.9 million increase in budget authority and $79 million increase in industry user fees. Under the president's proposal, FDA's Center for Devices and Radiological Health (CDRH) would receive $290.9 million—an increase of $7.14 million, or 2.5% more than in FY08.

Almost as soon as the Bush proposal was announced, it was met with a barrage of criticism from members of congress, professional societies, trade associations, mainstream media outlets, and a wide range of other stakeholders and advocacy groups. A leading critic and organizing force in seeking greater funding for the agency is the Alliance for a Stronger FDA (Silver Spring, MD), whose 177 members represent industry groups; nonprofit organizations; medical device, pharmaceutical, and related life science companies; three former secretaries at the Department of Health and Human Services; and six former FDA commissioners.

Describing the administration's budget proposal as “not only inadequate, but barely half of what FDA needs just to keep pace with inflation,” the alliance called for “budget levels that strengthen the agency and reflect the realities documented by a number of recent assessments.”

One of the assessments cited by the alliance and others seeking increased FDA funding is a November 2007 report prepared by a specially commissioned subcommittee of the agency's Science Board. The detailed, 300-page report, FDA Science and Mission at Risk, was adopted by the full board in December and received widespread attention in both industry and the general-interest press.

Requested by F DA Commissioner Andrew Von Eschenbach in 2006, the report's central finding is that FDA is in a “precarious position” and suffering from serious scientific deficiencies that threaten the agency's ability to meet “current or emerging regulatory responsibilities.” The report's central thesis is that FDA's resources have not kept pace with its increasing responsibilities.

Citing the Science Board report and its positive reception among policy makers on both sides of the aisle, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, says that the agency's FY09 funding will likely be increased as the budget works its way through Congress. “We believe we have a strong case for increased funding. We have the support of industry groups; medical device, drug, and other firms; nonprofits; and a host of other advocates and supporters. Basically, everybody is on board.”

Commenting on the administration's proposed funding for FDA's medical device related activities, Grossman 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 Bush budget proposal, the two leading medtech industry associations—which are both alliance members—offered more measured responses. Stephen J. Ubl, president and CEO of AdvaMed (Washington, DC), said he “appreciated the President's proposal to increase funding for the FDA . . . which would enable the agency to expand its resources to fulfill its mission to promote and protect the public health and to oversee the increasingly sophisticated medical technologies that play such a vital role in improving patient care.” Pleased with the balance between appropriations and user fees, Ubl continued, “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.”

Elaborating on AdvaMed's position, Janet Trunzo, executive vice president of technology and regulatory affairs, added, “There is no question that FDA could use additional appropriations to upgrade its infrastructure and to enhance its expertise to deal with the rapidly evolving pace of medical technology and pharmaceutical innovation. However, centers within the agency have varying needs for resources. For the device center, additional resources could be used for IT infrastructure, critical path projects, and enhancing scientific expertise.”

Mark Leahey, executive director of the Medical Device Manufacturers Association (Washington, DC), said, “We're relatively pleased with the funding proposal for CDRH, particularly with respect to keeping the user fees in balance. 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.”

Echoing the conclusions of the Science Board report, many agency observers agree that FDA's mission and scope have significantly expanded over the past 25 years. To carry out such increased responsibilities, some argue that the regulatory agency should receive increased funding from Congress rather than increased user fees. Or, failing such additional appropriations, that the agency's mission should be modified or scaled back.

Glen Paul Freiberg, president of RCQ Consulting (Rancho Santa Fe, CA) recognizes that FDA has legitimate concerns, particularly with regard to the need for more staff for product reviews and inspections. “The agency needs more primary reviewers for device submissions, and resources in the field for both domestic and foreign manufacturing facility inspections.”

But Freiberg contends that the agency also 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. “As in business, this could and should result in the reallocation of some resources and the elimination of others, to open slots for the primary mission tasks.”

Information about the proposed FY09 budget is available from the FDA Web site at www.fda.gov/oc/oms/ofm/budget/documentation.htm.

© 2008 Canon Communications LLC

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