AGDUFA III Negotiations with Industry
October 18, 2016
9:30 a.m. – 3:15 p.m.
FDA, Metro Park North, Rockville, MD
The overall purpose of the meeting was to discuss foundational resources needed for the program as it is today and moving forward.
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
Matt Lucia, CVM
Julie Bailey, CVM
Charli Long, CVM
Sharon Tarbell, CVM
Ruth Watson, Office of Legislation
Elizabeth Cash, Office of Chief Counsel
Industry: Generic Animal Drug Alliance (GADA)
Doug Rupp, Pharmgate, LLC.
Bill Zollers, Norbrook, Inc.
Herschel Gaddy, HJ Gaddy Associates
Jodi Beaudry, Bimeda
Alicia Henk, Ceva Animal Health
Ted Sullivan, GADA Legal Counsel
Kathy DeMarco, GADA Executive Director
The meeting began at 9:30 a.m.
- User Fee Process Costs, an educational presentation defining generic animal drug process costs, generic animal drug process FTEs, and cost model.
- Option C, a continuation and elaboration on an option presented by Industry at the September 14, 2016 meeting on funding and performance. FDA provided three additional levels of the option, modifying Industry’s methodology.
- Elimination of the Offset Provision described what the offset provision is, how it works, and the impact on the review program if eliminated as proposed.
- Workload Adjuster described FDA’s proposal to reset the base years. There was discussion regarding options for performance enhancements if increased workload projections don’t hold true.
- Changes to Fee Structure Proposal discussed increasing the share of revenue derived from product and sponsor fees and decreasing the share of revenue derived from application fees. Some of the industry representatives thought that some in the industry might want to see the percentage of revenue derived from applications increased.
- Change to the Process Trigger described the process trigger, background on FDA triggers, and the impact of not changing the current trigger. FDA proposed replacing the current Process Trigger with the “FY 2008 Animal Drugs and Feed: Center: Budget Authority” level, excluding fees, and adjusted for inflation.
Discussion with Industry on FDA’s Presentations
- The industry proposed two options: Option C.2 and Option C.3 to reflect shorter review times. CVM agreed to take the proposals under consideration.
- FDA is considering options for shorter review timeframes if workload decreases and to explore a performance methodology different from the workload adjuster.
- Industry requested final financial and performance numbers for FY2016 when they are finalized.
- No agreements were reached at the meeting; however, discussions are ongoing.
Establishment of Future Agenda
- FDA and Industry agreed to a teleconference to determine topics for the next meeting on November 9, 2016.
The meeting adjourned at 3:15 p.m.