AGDUFA IV Negotiations Meeting Minutes
September 28, 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 November 1, 2021, will satisfy the requirement in section 742(d)(1)(F) of the FD&C Act. The purpose of the meeting was for GADA to provide feedback on the September 21, 2021, negotiation session, for FDA to present its third proposal, for GADA to have an opportunity to ask questions, and for FDA and GADA to discuss a proposal for support of the integrity of the approval process.

Participants

FDA

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

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
Kathy DeMarco, Generic Animal Drug Alliance (GADA) Executive Director
Ted Sullivan, GADA Legal Counsel

The meeting began at 9:00 a.m. 

Feedback from the September 21, 2021, Negotiation Session (GADA)

GADA asked clarifying questions about FDA’s presentations on workload and submission complexity. GADA expressed understanding of the information provided on the impact of the COVID-19 pandemic.  FDA emphasized that limitations on the ability to conduct inspections have impacted the number of product approvals. 

FDA provided an explanation of the relationships between the number of applications reported in the AGDUFA performance report and the number of application fees collected for each fiscal year.

FDA’s Third Proposal

FDA outlined a third proposal with a new base cost. The proposal included a restructuring of the percentage of revenue coming from each of the three fee categories (sponsor, product, and application). FDA provided options for restructuring the application fee. FDA proposed changes to the workload adjuster based on models previously shared and discussed with GADA. FDA outlined possible program enhancements that could be included in the base cost. Finally, FDA outlined commitments for utilizing current AGDUFA carryover funds.

GADA provided initial thoughts on FDA’s third proposal. GADA stated that they were encouraged by the revisions FDA had made, however cautioned that the membership remains concerned with the projected cost of the program. GADA indicated their appreciation for the ways in which the proposal demonstrated FDA’s recognition of some of the concerns GADA has expressed during the negotiations, specifically with respect to the application fee and the workload adjuster. GADA reiterated their concern that the industry is funding the majority of the cost for the generic animal drug review process.

Opportunity for Questions (GADA) 

GADA asked questions about FDA’s statements and positions from previous negotiation sessions in an effort to increase their understanding of the Agency’s perspective.

Supporting the Integrity of the Approval Process proposal (FDA and GADA)

FDA and GADA agreed that metrics need to be explored with respect to this proposal. 

Discussion of Negotiation Timeline

FDA and GADA agreed to work toward the completion of AGDUFA IV negotiations by November 1, 2021.

The meeting adjourned at 12:45 p.m.