AGDUFA IV Negotiations Meeting Minutes
August 3, 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. The overall purpose of this meeting was to discuss follow-up action items from the second meeting, for GADA to respond to FDA’s proposed AGDUFA IV package, and for FDA to share a presentation on workload complexity.
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
Gypsi Feeney, CVM
Elizabeth Cash, Office of the 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.
Follow-Ups from Previous Meeting
- Ground Rules: FDA and GADA finalized language for a new provision to clarify the time frame during which the ground rules will apply, including a provision for expiration of the rules if one party believes a negotiation impasse has been reached. In such a case, either party will provide a 14-day notice to the other, before acting outside the ground rules.
- GADA Data Request: GADA had not had time to review all the information FDA provided. GADA may have clarifying questions or additional data requests, which they plan to send prior to the negotiation session scheduled for August 24, 2021.
- Denominator Discussion: FDA explained the factors contributing to why the numbers of sponsors and applications have remained consistent over the past several years despite significant workload growth in the program.
- Appropriation Discussion: GADA stated that a foundational part of the AGDUFA IV negotiations for industry is to modify the proportions of the AGDUFA program being funded by budget appropriations (BA) and user fee money to be more similar to the proportions in the Animal Drug User Fee Act (ADUFA) program. FDA expressed its position that the negotiations need to focus on the AGDUFA program. FDA explained the process it follows for requesting additional appropriations and shared the complicating factor that requests for new funding have competing priorities as they move outside the Center to FDA, the Department of Health and Human Services (HHS), the Office of Management and Budget (OMB), and Congress. FDA is not at liberty to share its appropriations requests until they become public as part of the budget delivered to Congress.
GADA stated that their presentation aimed to represent the membership’s feedback on the FDA’s July 22, 2021 proposal. Individual member company views may differ from the view that GADA presents as a membership during the negotiations. GADA is committed to negotiating in good faith to facilitate the public health mission of the generic animal drug program.
GADA shared a concern that they believe GADA and FDA may not share the same ultimate goal with respect to the AGDUFA program. GADA clarified that their goal was a functional user fee program that supports an efficient FDA review increasing the availability of high-quality, low-cost generic animal drugs and that the user fee program must employ a cost-effective and equitable payment structure. GADA provided specific feedback on FDA’s proposal, with their primary concerns being the disproportionately high amount of user fee funding for the AGDUFA program, the workload adjuster, and the proposed cost of the base year of AGDUFA IV. GADA presented a proposal for AGDUFA IV reauthorization, keeping program performance at the current AGDUFA III levels, and provided a financial model based on actual program spend in FY2020 (adjusted for inflation) with BA and user fee funding at the same proportions as ADUFA.
FDA asked clarifying questions related to GADA’s presentation and proposal.
FDA Presentation on Workload Challenges
FDA shared a presentation on its experiences over the current authorization period due to increased workload. The rapid growth seen during the AGDUFA II reauthorization period continued into the current AGDUFA III authorization period. FDA shared submission workload trends. FDA shared trends in workload complexity, including shifts to more complex dosage forms and more challenging products with respect to demonstrating bioequivalence. During the current AGDUFA III authorization period, meeting review timeframes has remained the top priority for FDA. While focusing on meeting AGDUFA timeframes, other critical program activities such as guidance development, question-based review creation, and continued process improvements, have slowed or paused.
GADA asked clarifying questions related to FDA’s presentation.
FDA and GADA discussed action items and next steps in the negotiation process in preparation for the meeting scheduled for August 24, 2021.
The meeting adjourned at 1:15 p.m.