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Will FDA Budge On User Fee Hike Reductions? Stakeholders To Meet In May

This article was originally published in The Gray Sheet

Executive Summary

The current preoccupation with FDA postmarket safety on Capitol Hill could dispose legislators toward the agency's stance that year-over-year user fee hikes should not be held to the inflationary rate alone

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FDA uneasy about caps on user-fee hikes: CDRH Director Dan Schultz acknowledges "more areas of agreement than there are disagreement" when it comes to industry and FDA views on MDUFMA, but says the prospect of caps is "of concern to us." Schultz' pithy remark came during a March 5 breakfast session of AdvaMed's annual meeting in Dana Point, Calif. AdvaMed and the Medical Device Manufacturers Association are asking that future year-over-year fee hikes be held at the inflationary rate. Industry is pursuing the change via MDUFMA "trigger-fix" legislation that may be considered next month (1"The Gray Sheet" Feb. 7, 2005, p. 11). "The uncertainty of not knowing where this is to end is very, very difficult" for administrative decisions, Schultz commented, suggesting he wants to retain flexibility for the program. By agreeing to such a proposal, however, FDA might secure assurance that industry will not attempt a significant overhaul of the user-fee program when it is reauthorized in 2007...

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