ADUFA Negotiations with Industry
January 10, 2017
9:00 a.m. – 3:00 p.m.
The overall purpose of the meeting was to discuss Industry’s responses to FDA’s financial proposals and FDA’s response to Industry’s proposed 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
Petra Garosi, CVM
Cindy Burnsteel, CVM
Julie Bailey, CVM
Sharon Tarbell, CVM
Linda Wilmot, CVM
Susan Storey, CVM
Dan Benz, CVM
Urvi Desai, CVM
Jill Adleberg, 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
Kelly Klaus, AHI
Industry’s Presentation and Responses to FDA’s Financial Proposals
AHI began with a proposal for creating a process for the establishment of an import tolerance performance goal. FDA will consider the proposal and provide a response at a future meeting.
AHI provided its perspectives concerning FDA’s financial proposals from the October 2016 negotiation meetings. Topics discussed included the fee structure, waiver proposals, the inflation adjuster, the 5-year offset provision, and workload adjuster. AHI is supportive of certain aspects of FDA’s financial proposals, including having a tiered sponsor fee and, with regard to the workload adjuster, resetting the base years to ADUFA III (FY2014-FY2018). However, AHI expressed concerns regarding some other aspects of FDA’s proposals. AHI requested additional details on FDA’s total funding increase request for ADUFA IV. FDA will provide additional details at a future meeting.
FDA’s Responses to AHI’s Enhancement Proposals
FDA and AHI discussed review times for approval of Combination Drug Medicated Feeds; shortened administrative action times (Categorical Exclusions, Memorandum of Conference; and Administrative NADAs); performance goals for tissue residue method validation process; foreign inspections; and phased Chemistry, Manufacturing, and Controls (CMC) submissions. FDA and AHI explored opportunities for improving review process transparency and providing Agency guidance on common submission issues. The Agency has determined that Data Protection/Marketing Exclusivity is not a topic to be handled through user fee negotiations. FDA agreed to provide a cost proposal for the enhancement proposals.
FDA and Industry agreed to determine future agenda items at a later date.