Article preview from "The Gray Sheet"- July 11, 2011
FDA says industry's reluctance to put a five-year user fee reauthorization plan on the table for discussion is delaying progress toward 2012 user fee legislation.
Article preview from "The Gray Sheet"- July 11, 2011
During June 17 negotiations, the agency criticized industry's recent proposal to reauthorize company-paid user fees for only two years, not five, arguing that it would only exacerbate issues around program stability and staff turnover.
"It does not address congressional intent for a five-year reauthorization, increases the cost of the reauthorization process, and creates uncertainty by de-linking MDUFA reauthorization" from the drug user fee package, FDA wrote in minutes from the closed-door meeting, released July 7.
Device industry reps had suggested June 1 that user fees be essentially frozen at fiscal 2012 levels while FDA worked toward meeting qualitative and quantitative performance goals that were agreed to in the 2007 user fee agreement.
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