ADUFA IV Negotiations with Industry
April 18, 2017
9:00 a.m. – 1:30 p.m.
FDA, Metro Park North, Rockville, MD
The overall purpose of the meeting was to finalize financial proposals and program enhancements.
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
Cindy Burnsteel, CVM
Julie Bailey, CVM
Sharon Tarbell, CVM
Jill Adleberg, Office of Legislation
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
Sean Parker, Phibro
Kelly Klaus, AHI
The FDA and AHI negotiating teams reached acceptable understanding on a total funding package for ADUFA IV. FDA and AHI agreed to a proposal relating to the offset provision and a proposal to reset the workload adjuster base years from fiscal year (FY) 2009–2013 to FY 2014–2018.
Program Changes or Enhancements
The FDA and AHI negotiating teams also agreed on program changes and/or enhancements relative to: foreign GMP inspections; review times for certain ADAA combination applications; timeframe for review of end game categorical exclusions; pre-submission conference scheduling; electronic submissions; scheduling tissue residue method demonstrations; use of user funds for the processing of Freedom of Information requests relating to pre-market review process; publication of approvals online; use of user fee funds for review of conditional approval applications; label change on indexed products; and exemption of all fees except application fees for biopharm animals.
The FDA and AHI negotiating teams will share the accepted proposals with their respective ratifiers.
No further meetings are scheduled as of now.