FDA, Industry Haggle Over Price For New User Fee Deal

Article preview from "The Gray Sheet"- January 17, 2012

As of last month, FDA and industry were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two are still haggling over the total amount companies will need to shell out in the five-year user fee reauthorization.

FDA, Industry Haggle Over Price For New User Fee Deal

Article preview from "The Gray Sheet"- January 17, 2012

FDA and device industry negotiators have zeroed in on what program improvements they’d like to see in the 2012 user fee pact, but a significant gap remains on how much the two parties believe industry should pay in the final agreement.

As of last month, they were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two were still haggling as recently as last week over the price of the five-year deal, which will reauthorize from fiscal 2013 through fiscal 2017 the fees paid by industry to support pre-market program improvements. The current user fee agreement expires at the end of September.

According to minutes from multiple negotiation sessions released by FDA Jan. 12, the agency initially proposed collecting $1.15 billion in user fees over five years, quadrupling the nearly $300 million in user fees collected from 2007-2012. But FDA was talked down to $730 million-$805 million over five years, depending on whether performance criteria are met, and on workload.

“FDA believes that the program is not currently on a sound financial footing,” the agency summarized in Nov. 3 meeting minutes.

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