AGDUFA IV Negotiations Meeting Minutes
September 16, 2021, 9AM – 5PM
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
Gypsi Feeney, CVM
Cassie Ravo, CVM
Lisa Kable, CVM
Petra Garosi, CVM
Elizabeth Cash, Office of Chief Counsel (OCC)
Alissa Jijon, OCC
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.
Ground Rules Discussion
FDA and GADA discussed modifications to the AGDUFA IV negotiations ground rules specifically with respect to information exchanged between the parties during the negotiation process.
Data Requests Discussion (GADA)
GADA stated that they are requesting data from FDA to explain to the full membership the rationale for FDA’s requested increase in base funding for AGDUFA IV. GADA expressed their view that the information CVM has provided does not fully explain the need for increased funding and indicated that they would like to see the actual FY 2021 spend information. FDA is committed to working to provide as much information as possible to GADA and explained that the FY 2021 actual spend information is not yet available for dissemination.
Feedback on CVM’s Second Proposal (GADA)
GADA expressed their concern that FDA’s proposed base year cost for AGDUFA IV would drive the ratio of budget appropriations (BA) to user fee revenue further from what is equitable. GADA stated that CVM’s second proposal must dramatically increase the number of full-time employees (FTEs) without any notable change in performance goals over AGDUFA III. FDA reminded GADA that the performance goals were reduced from AGDUFA II to AGDUFA III despite the significantly increasing workload. GADA expressed disagreement with the approach of a compounded workload adjuster, stating that they view the adjuster as an inaccurate representation of workload and noting that it is a backward-looking measure. GADA expressed the desire that FDA secure additional BA in future years to support non-review activities. GADA conveyed that their membership has concerns about an amendment to the AGDUFA legislation to include post-approval activities and explained that post-approval initiatives would need meaningful metrics to gain support from the membership. Overall, GADA expressed their view that FDA’s proposal represents a significant increase in user fee funding and that such a significant increase every five (5) years would be detrimental to the industry.
Workload Adjuster and Challenges/Complexity (GADA)
GADA presented their thoughts on the workload adjuster and workload challenges and complexity. GADA stated that they perceive a disconnect between the CVM review team personnel’s responsibilities and actual resource needs for a cost-effective, efficient review process. GADA provided their interpretation of workload trends for review staff over time, referencing their understanding of metrics, including the number of submissions per FTE, overall workload, workload complexity, and submission quality. GADA restated that based on their analysis of the review workload, they do not support the compounding (year over year) of the workload adjuster. GADA discussed the feasibility of providing for FTEs in the workload adjuster.
GADA’s Second Proposal
GADA stated a desire to build a program based on actual spending, which they expressed would be difficult given the lack of availability of actual FY 2021 spend levels at this point. GADA proposed base funding for FY 2024 with reference to FY 2020 spend levels. GADA’s proposal also included the following:
- maintaining AGDUFA III performance timeframes,
- setting a workload adjuster cap with a rolling average that is not compounded,
- reallocating fee-type revenue to annual revenue,
- changing the application fee structure,
- funding program enhancements through BA or one-time costs, and
- defining usage of carryover funds.
In response to GADA’s second proposal, FDA shared the carryover fund status and its plans to reduce the carryover balance.
Further Discussion, Restructure of Application Fee/Implementation of Investigational (or JINAD) Fee
FDA and GADA discussed restructuring the application fee, with the fee being based on complexity (waiver, bioequivalence, etc.) of the application. FDA and GADA discussed benefits and disadvantages of an investigational fee.
FDA and GADA discussed the workload adjuster. GADA will consider further and convey to FDA how they prefer the averages to be calculated (3, 4, or 5 years). FDA will model scenarios of various submission types for possible inclusion in the workload adjuster.
Four (4)-Tier Sponsor Fee Proposal
GADA proposed leaving the current sponsor fee structure as is.
Proposed Performance Enhancements/ Business Process Improvement Initiatives
FDA asked GADA to consider which recommendations from the process improvement working groups they would find to be most impactful to the program. FDA explained that the inclusion of process improvement goals in the user fee goals letters allows the Agency to prioritize these items over other non-review tasks and to ensure they are accomplished within the established timeframes.
Action Items and Establishment of Future Agendas
- FDA and GADA discussed action items from the session.
- FDA and GADA discussed the topics for the next meeting, scheduled for September 21, 2021.
The meeting adjourned at 4:00 p.m.