AGDUFA III Negotiations with Industry
September 14, 2016
9:00 a.m. – 2:45 p.m.
FDA, Metro Park North, Rockville, MD
Section 742(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 Generic Drug User Fee Act (AGDUFA) program, AGDUFA III. For the AGDUFA III negotiations, regulated industry is represented by the Generic Animal Drug Alliance (GADA). FDA’s meetings with GADA, which tentatively are planned to run through November 2016, will satisfy the requirement in section 742(d)(1)(F) of the FD&C Act. The overall purpose of the meeting was to discuss Industry’s economic forecast, financial model options, and FDA’s human resource needs.
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
Sharon Tarbell, CVM
Ruth Watson, Office of Legislation
Lori Talley, Office of Chief Counsel (OCC)
Elizabeth Cash, (OCC)
Industry: Generic Animal Drug Alliance (GADA)
Doug Rupp, Pharmgate, LLC.
Herschel Gaddy, HJ Gaddy Associates
Jodi Beaudry, Bimeda
Randy McCallum, Sparhawk Labs
Gerald Macedo, Med-Pharmex, Inc.
Alicia Henk, Ceva Animal Health
Ted Sullivan, GADA Legal Counsel
David Zorn, Consultant to GADA
Kathy DeMarco, GADA Executive Director
The meeting began at 9:00 a.m.
Industry’s Economic Forecast
- GADA’s presentation, Presentation on Market Influences Regarding Generic Animal Drugs, discussed the economic state of the agricultural industry including farms and ranches; economic challenges in the US and globally; economic status of veterinary schools, students, and practices; and the impact of other marketing venues on traditional veterinary clinics. GADA concluded these factors would create challenges for the growth of the generic animal drug market.
Industry’s Financial Model
- GADA presented Options for AGDUFA III, Legislative Targeted Fees. The presentation included three options for discussion, including maintaining 2018 targeted level of funding (option A); maintaining the level of fees obligated in 2015 (option B); and maintaining the 2016 FTEs and the average fee contribution per FTE (option C). GADA explained why its options do not include a workload adjuster. No decision was made at this time.
- GADA presented a spreadsheet showing AGUDFA I and AGDUFA II Historical Capacity and Resources, including total numbers of submissions each year.
FDA Resource Needs for AGDUFA III
- FDA’s presentation, Providing a Comprehensive Understanding of Human Resource Needs in AGDUFA III, covered the following topics:
- Capacity at the Program and Reviewer Level
- Increased Cost of Meeting Performance Goals
- Warning Signs of Future Performance Deterioration
- Historic increase in submissions: increased volume of work and communications
- Knowledge of upcoming future submissions: knowledge of upcoming mergers and acquisitions; products coming off patent
- Less time to develop capacity: acquisition of knowledge and skills, development of policies, creation of guidance, etc.
- Total number of submissions per reviewer has grown: longer review queues; increase in complex submissions
- Increased complexity of the science and technology presented.
- FDA expects its workload will continue to increase. Workload increases require adequate staffing to meet performance goals.
Establishment of Future Agendas
- FDA and Industry discussed the topics for the next meeting on October 18, 2016.
The meeting adjourned at 2:45 p.m.