AGDUFA IV Negotiations Meeting Minutes
August 24, 2021, 9AM – 1PM
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 IV. For the AGDUFA IV negotiations, regulated industry is represented by the Generic Animal Drug Alliance (GADA). FDA’s meetings with GADA, which tentatively are planned to run through October 1, 2021, will satisfy the requirement in section 742(d)(1)(F) of the FD&C Act.
Matt Lucia, Center for Veterinary Medicine (CVM)
Roxanne Schweitzer, CVM
Tim Schell, CVM
Julie Bailey, CVM
Chuck Andres, CVM
Cassie Ravo, CVM
Lisa Kable, CVM
Petra Garosi, CVM
Elizabeth Cash, Office of Chief Counsel
Matt Lockeed, Office of Legislation
Stephanie Batliner, Bimeda Inc
Ben Moses, Dechra Veterinary Products LLC
Courtney Arumugam, Piedmont Pharma
Herschel Gaddy, Herschel Gaddy & Associates Consulting
Tom Campi, Huvepharma EOOD
Teena Middleton, Quo Vademus LLC
Doug Rupp, Pharmgate, Inc
Kathy DeMarco, Generic Animal Drug Alliance (GADA) Executive Director
Ted Sullivan, GADA Legal Counsel
The meeting began at 9:00 a.m.
FDA Workload Adjuster (WA) Presentation
FDA explained the types of submissions included in the WA and gave the methodology used to calculate each column in the WA Calculation table in the fee notices in the Federal Register. GADA asked clarifying questions about when the WA is implemented. FDA responded that the WA is implemented when the total of the weighted averages of time multiplied by the change in the numbers of each sentinel submission type submitted from the most recent 5-year period over the base 5-year period is greater than 1%. GADA expressed concern about the base-years being fixed rather than a rolling average. FDA offered to provide GADA with alternate WA scenarios, such as rolling 3-year and 5-year averages. FDA emphasized that its proposed workload adjuster cap would address large increases in the fee rates year over year.
GADA Presentation on the Restructuring of the Application Fee
GADA stated their belief that FDA and GADA are still far apart on base-year funding based on the proposals that have been exchanged. GADA stated that a large application fee may be a barrier for many member companies. GADA presented three ideas for major changes to the AGDUFA fee structure:
- Shifting the application fee to be less than 25% of the program’s revenue.
- Splitting up the application fee with some costs occurring in the investigational phase.
- Creating different tiers of application fees based on complexity.
FDA agreed that lowering the application fee as a percentage of the overall program revenue creates a more stable and predictable revenue stream. FDA understood the concepts that GADA presented for breaking up the application fee and cautioned against an apparent “fee for service” program. FDA stated that IT costs would be associated with a restructuring of the fees and administrative costs would increase to implement a more complicated fee structure. GADA suggested that the IT costs be one-time costs and perhaps funded from carryover.
GADA Follow-Up Questions
GADA asked for additional program data from FDA to help them develop a formal proposal for a fee structure that puts fee payment closer to the time CVM performs the work (e.g., an investigational phase fee). GADA asked to hear more about FDA’s proposal for post- approval spending. GADA asked questions about the base-year funding proposed by FDA, how this relates to user fee spending in the FY 2020 financial report, and how carryover dollars can be used to fund AGDUFA IV.
FDA and GADA discussed action items and next steps in the negotiation process in preparation for the meeting scheduled for September 16, 2021.
The meeting adjourned at 1:10 pm.