ADUFA Negotiations with Industry
October 24, 2016
10:15 a.m. – 2:45 p.m.
FDA, Metro Park North, Rockville, MD
Section 740A(d)(1)(F) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with representatives of the regulated industry to negotiate recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA) program, ADUFA IV. For the ADUFA IV negotiations, regulated industry is represented by the Animal Health Institute (AHI). FDA’s meetings with AHI, which tentatively are planned to run until March 2017, will satisfy the requirement in section 740A(d)(1)(F) of the FD&C Act.
This was the initial meeting. The overall purpose of the meeting was to discuss meeting ground rules and logistics, to develop a plan for the negotiation process, and to allow FDA to deliver its initial perspective on ADUFA IV.
Roxanne Schweitzer, Center for Veterinary Medicine (CVM)
Steve Vaughn, CVM
Cassie Ravo, CVM
David Wardrop, CVM
Beth Luddy, CVM
Chuck Andres, CVM
Dennis Bensley, Jr., CVM
Petra Garosi, CVM
Cindy Burnsteel, CVM
Julie Bailey, CVM
Sharon Tarbell, CVM
Ruth Watson, Office of Legislation
Lori Talley, Office of Chief Counsel
Industry: Animal Health Institute (AHI)
Rich Carnevale, AHI
Grace Gowda, Merial
Beth Norton, BIVI
Gareth Harris, Merck
Chan Baldwin, Zoetis
Todd Rhodes, Bayer
Kathy Vannatta, Elanco
Kent McClune, AHI
Kelly Klaus, AHI
Introduction of FDA and AHI Participants
Recognition of Negotiating Leads
- FDA: Roxanne Schweitzer and Steve Vaughn
- AHI: Rich Carnevale
AHI’s Letter of Assurance of Representation of Majority of Industry
- AHI had previously shared written confirmation with FDA that it represents a majority of the animal drug industry. AHI reaffirmed this representation verbally at the meeting.
- The ground rules that will govern ADUFA IV negotiations were discussed and agreed to by FDA and Industry.
- In their opening presentation, FDA shared two objectives for the negotiations: ensuring predictable and sustained revenue to have the capacity to meet and exceed performance goals and to continue to invest in quality program improvements; and, smart/sustainable long-term financial planning.
- FDA presented Engineer the Animal Drug Program for the 21st Century which described the current state, future direction, challenges, and potential enhancements to the program.
- FDA also provided potential financial enhancements for the program, which included: elimination of the offset provision; resetting base years for the workload adjuster, and proposed changes to the fee structure.
- FDA presented on the regulation of combination drug medicated feeds by providing an overview and recommendations.
- FDA and Industry agreed the agenda for the next meeting on October 27, 2016, would include AHI’s perspective on ADUFA IV and FDA’s proposal concerning the inflation adjuster.