ADUFA Negotiations with Industry
October 27, 2016
The overall purpose of the meeting was for Industry to provide its opening presentation for the ADUFA IV negotiations and for FDA to follow-up on two financial topics from the first meeting.
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
Shruti Modi, Office of Legislation
Lori Talley, Office of Chief Counsel
Industry: Animal Health Institute (AHI)
Rich Carnevale, AHI
Grace Gowda, Merial
Beth Norton, BIVI
Chan Baldwin, Zoetis
Todd Rhodes, Bayer
Kathy Vannatta, Elanco
Kent McClune, AHI
Sean Parker, Phibro
Kelly Klaus, AHI
FDA Financial Presentation
FDA presented a proposal to change the inflation adjuster. FDA proposes moving from the Consumer Price Index for Urban Consumers (CPI-U) Less Food and Energy to CPI-U All Items (Washington-Baltimore). FDA believes this will provide a more consistent, less volatile, more transparent means for the ADUFA inflation adjuster. Industry agreed to review the proposal.
AHI presented its opening presentation, first describing its organizational aspects, member firms, and mission. Topics included AHI’s observations and objectives going into ADUFA IV, as well as specific matters including approval of combination drug medicated feeds, conditional approval, shortened administrative action timelines, tissue residue method process, foreign inspections, phased chemistry manufacturing controls (CMC) review, and review process transparency. Additionally, AHI proposed that FDA provide guidance for and work with Industry on submission issues to improve submission quality. Lastly, the presentation included proposals concerning data protection and marketing exclusivity.
FDA Additional Financial Information
As requested at the prior negotiation meeting, FDA provided variations of the fee rates with the proposed increase; with proposals of change in percent of revenue from four fee types; and with change proposed to Sponsor fees. FDA also provided the percentages of budget authority versus user fees for the FY2015 and with proposed increase for ADUFA IV.
Negotiations will resume in January 2017. FDA and Industry agreed to determine future agenda items at a later date.