AGDUFA IV Negotiations Meeting Minutes
July 22, 2021, 9AM – 1PM
Format: Virtual

Purpose

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 initial meeting, for FDA to share a presentation on a proposed AGDUFA IV package, and for GADA to share a presentation on their priorities for AGDUFA IV.

Participants

FDA

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
Linda Walter-Grimm, CVM
Alissa Jijon, Office of the Chief Counsel (OCC)
Lori Talley, OCC
Matt Lockeed, Office of Legislation

GADA

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 9:10 a.m. 

Follow-Ups from Previous Meeting

• Scope of the negotiations: FDA reiterated the request from Congress that AGDUFA negotiations not include proposed statutory changes outside of changes to sections 741 (fees) and 742 (reauthorization and reporting requirements) of the FD&C Act. 
• Ground rules: FDA and GADA discussed language for a new provision to clarify how long the ground rules would remain in effect following the conclusion of the negotiations. 
• Financial: FDA re-shared how targeted revenue is calculated and shared a mock-up of the carryover balances for the AGDUFA program if the workload adjuster had not been invoked during the current AGDUFA III period. FDA shared the percentage of funding for generic new animal drug evaluation derived from user fees and appropriations over time, as well as a comparison of that ratio to other user fee programs in the Agency.

FDA Presentation on AGDUFA IV Package

FDA presented a proposal package for the AGDUFA IV program. The proposal included the following: a base dollar amount to continue the program’s current performance goals, premarket program enhancements (Chemistry, Manufacturing, and Control (CMC) and bioequivalence), a workload adjuster proposal, and post-approval enhancements. GADA asked FDA to present the costs for the targeted post-approval enhancements separately from the rest of the package. The GADA negotiating team will take the proposal back to the full membership for consideration and feedback.

GADA Presentation on Priorities for AGDUFA IV

GADA shared a presentation on their priorities for the AGDUFA IV program. The biggest concern expressed relates to the disparity between the proportion of the Animal Drug User Fee Act (ADUFA) program funded by appropriations, as compared to user fees, and the proportion of the AGDUFA program funded by appropriations, as compared to user fees. A second major concern expressed relates to the size of the application fee. GADA would like to see a restructuring of the AGDUFA fees that links collections and revenue more closely to workload. GADA expressed the view that although the workload is increasing and triggering the workload adjuster, the number of generic animal drug fee-paying applications (and approvals) is not also increasing at the same pace.

Establishment of Future Agendas

• FDA and GADA discussed the topics for the next meeting on August 3, 2021.
• FDA and GADA discussed adding sessions to the negotiation in September 2021.

The meeting adjourned at 12:45 p.m.