President Bush's Feb. 4 budget request asks for about $7 million in additional funds for FDA's device program in fiscal year 2009 compared to current levels, but would cut 10 full-time staff equivalents at CDRH.
The requested funds cover cost-of-living increases and a small bump in device import oversight spending. Device FTEs within the agency's Office of Regulatory Affairs field inspection branches would hold at 2008 levels (421 FTEs), but CDRH would go from 1,125 to 1,115 FTEs if the proposal were to become law.
Further, about $1.4 million in savings gained from "FDA modernization efforts" are being redirected away from CDRH to "higher level priorities," budget documents note.
"CDRH doesn't do so well in this budget," said Steven Grossman, a deputy executive director for the Alliance for a Stronger FDA, a consortium of former government employees and professional, patient and industry groups lobbying for more FDA funds. "Nobody does, but CDRH does particularly poorly."
The budget request designates $290.9 million to FDA device activities, which includes ORA device-focused field efforts and all of CDRH funding, in 2009. Congress would supply $241.9 million of the amount and $49 million would come from industry user fees.
Overall, the proposal directs about $2.4 billion to FDA, including $1.8 billion in appropriations and $628 million in user fees. This represents a $130 million increase compared to 2008.
Democrats Swiftly Come Out Against Request
Members of the Democratic majority in the House and Senate were quick to criticize the request.
"The administration's slight funding increase proposed for FDA is woefully inadequate," said Bart Stupak, D-Mich., chair of the Energy and Commerce Subcommittee on Oversight and Investigations.
Stupak's subcommittee held a hearing Jan. 29 in response to a 1report issued last November by the FDA Science Advisory Board with strongly worded warnings that the agency lacked the resources to fulfill its mission (2"The Gray Sheet" Dec. 10, 2007, p. 5).
At the hearing, writers of the Science Board report were joined by a Government Accountability Office rep criticizing the agency's performance and its prospects under current funding levels (3"The Gray Sheet" Feb. 4, 2008, p. 6).
Stupak, along with Energy and Commerce Chairman John Dingell, D-Mich., Health Subcommittee Chair Frank Pallone, Jr., D-N.J., and chair of the House Committee on Oversight and Government Reform Henry Waxman, D-Calif., wrote a letter to Science Board member Gail Cassell Feb. 5, requesting an assessment of the FDA budget and an independent recommendation for "sufficient" funding amounts. Cassell, VP of scientific affairs at pharmaceutical company Eli Lilly, led the team of agency advisors that wrote the report.
One of her colleagues on the project, Peter Barton Hutt, senior counsel at Covington & Burling and a former FDA chief counsel, told Stupak's subcommittee agency that funding should be doubled and 50% more personnel need to be added during the next two years. The agency is "barely hanging on by its fingertips," Hutt said (4"The Gray Sheet" Feb. 4, 2008, p. 4).
Lobbyists See Opportunity For Bigger Funding Hike
Grossman says the substantial congressional pressure on FDA resource issues makes him "upbeat" that improvements will be made to the funding package as it moves through Congress. The Alliance for a Stronger FDA, of which both AdvaMed and the Medical Device Manufacturers Association are members, is seeking $2.1 billion for FDA from Congress in 2009, plus user fees.
"Look what we have going for us in the 2009 cycle," Grossman said. "We have the FDA Science Board's report, we have two GAO reports, we have 18 months of work by our organization, and the Energy and Commerce Committee has already held hearings this year."
"We did pretty well in '08, considering the terrible budget environment, and we are still gathering strength."
Separately, AdvaMed took a less critical tone on Bush's FDA request, calling it a "good start," but also appeared focused on working with Congress for improvements. "FDA could benefit from additional increases in appropriations to better prepare for the future and to perform its core functions," said Steve Ubl, the device trade association's CEO.
Import Oversight, IT Get Some Attention In Request
At the Jan. 29 Energy and Commerce Subcommittee hearing, the Science Board's Cassell told the panel that FDA's most critical needs are to fix its aging information technology systems, improve recruitment and retention of personnel and to increase inspections of imported food, drugs and devices.
The budget request includes $17.4 million in added funds earmarked for "medical product safety and development." Included in that figure is $677,000 designated to improve the Office of Regulatory Affairs field offices' device import safety efforts.
The administration also requested an increase in IT funding for each of FDA's centers, according to FDA Deputy Commissioner for Operations John Dyer.
The budget proposal includes $254 million for FDA IT, an increase of 2.8% from 2008. Dyer said the IT money would go to various initiatives, "everything from getting MedWatch off the ground ... to building a new data operations center as we move to the new White Oak [Silver Spring, Md.] facility."
Robert Miller, deputy direction of FDA budget formulation, acknowledged the pressure to increase agency resources, but he pointed to the "overall tight budget atmosphere" and suggested the administration's proposal represents a serious effort to improve FDA performance under challenging circumstances.
"You have to look at the overall budget climate," Miller said. "The department [HHS] is taking overall a 3% reduction, while FDA is going up 6%."
- Sue Darcey
