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February 21, 2017 Meeting Minutes

ADUFA Negotiations with Industry
February 21, 2017
9:00 a.m. – 9:50 a.m.
Rockville, MD


Purpose:

The overall purpose of the meeting was to continue discussion on financial proposals and proposed program enhancements.

Participants

FDA

Roxanne Schweitzer, Center for Veterinary Medicine (CVM)
Steve Vaughn, CVM
Cassie Ravo, CVM
David Wardrop, CVM
Beth Luddy, CVM
Dan McChesney, CVM
Chuck Andres, CVM
Matt Lucia, CVM
Dennis Bensley, Jr., CVM
Petra Garosi, CVM
Julie Bailey, CVM
Sharon Tarbell, CVM
Jill Adleberg, Office of Legislation
Lori Talley, Office of Chief Counsel

Industry: Animal Health Institute (AHI)

Rich Carnevale, AHI
Alex Matthews, AHI
Grace Gowda, Merial
Beth Norton, BIVI
Chan Baldwin, Zoetis
Todd Rhodes, Bayer
Kathy Vannatta, Elanco
Kelly Klaus, AHI

This meeting was a continuation of the discussion from the prior meeting at which no agreements were reached. AHI indicated they do not agree with FDA’s original proposed ADUFA IV package, or with FDA’s total package, which includes funding for post-market activities. FDA then provided more information about the benefit of including post-market activities. FDA also talked about some of the benefits of the ADUFA program including faster review timeframes, increased predictability, etc. and described some of the challenges it would face without additional funding (e.g., loss of efficiency and inability to continue to meet performance goals).

AHI proposed keeping ADUFA III funding plus inflation and maintaining current review timeframes. FDA countered that it is unable to maintain current performance without a funding increase. AHI explained that it is not authorized to agree to such a substantial fee increase without significant program enhancements. FDA clarified that its ADUFA IV proposal does include a number of the program enhancements suggested by AHI, but acknowledged the enhancements of greatest interest and benefit to AHI could not be included due to FDA’s negotiation team being prohibited from discussing them as part of the ADUFA IV negotiation meetings. AHI clarified that program enhancements currently under discussion do not any way justify the magnitude of increased fees that FDA is seeking from industry.

AHI requested that FDA provide an alternate financial proposal for ADUFA IV.

No further discussion.