User Fee Negotiators Far Apart: Industry Seeks To Delay New Fee Levels Until FDA Improves Performance

Article preview from "The Gray Sheet"- June 20, 2011

Device industry reps say industry-paid FDA user fees should be reauthorized for only two years, not five, to allow ongoing changes to FDA's pre-market review programs to sink in before a more meaningful user fee package is passed.

User Fee Negotiators Far Apart: Industry Seeks To Delay New Fee Levels Until FDA Improves Performance

Article preview from "The Gray Sheet"- June 20, 2011

"It would be impractical to develop meaningful goals and resource needs for a predictable five-year program," industry said, according to minutes prepared by FDA summarizing June 1 negotiations. The minutes were released last week.

FDA and device industry negotiators are nearing a self-imposed end-of-June deadline for reaching an agreement on the terms and cost of the next user fee reauthorization package. The agreement will serve as the foundation for legislation, which would need to be enacted by September 2012 to prevent the current user fee program from expiring.

But public minutes from the negotiations increasingly paint a picture of two sides with little to agree on, and a draft agreement in the coming weeks is unlikely, the negotiators say.

Industry officials involved in the negotiations say the discussions have been cordial, but acknowledge that there is a big gap between their positions and the agency’s on core issues.

Representatives from AdvaMed, the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance point out that FDA is failing to meet some of its goals from the prior user fee agreement, including PMA review goals.

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