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Thompson on user fees

This article was originally published in The Gray Sheet

Executive Summary

Additional Medical Device User Fee & Modernization Act funds are forthcoming, HHS Secretary Tommy Thompson assures FDA Science Forum attendees April 24 in Washington, D.C. Responding to an audience query about the role of the Office of Management & Budget in device appropriations, Thompson reported that FDA Commissioner Mark McClellan "advanced the budget with the money in, and we advanced it to OMB. I didn't realize that in America we had a 'Super God' until I came to Washington, D.C., and I found out [it] is OMB. Congress is going to respond.... We have to work within the guidelines with OMB, [but] at the end of the day...I am absolutely certain there's going to be some additional money" for devices. Industry is seeking a $28.5 mil. increase in the FY 2004 FDA budget to sustain the user-fee program (1"The Gray Sheet" April 21, 2003, In Brief)...
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