AGDUFA IV Negotiations Meeting Minutes
September 21, 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 purpose of the meeting was for CVM to address issues raised by GADA in the September 16, 2021, negotiation session. 

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
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 provided comments on GADA’s presentation from the September 16, 2021, negotiation session, specifically with respect to the cyclicity of review, review complexity, and submission volume. FDA discussed the impact of the COVID-19 pandemic on approvals, referencing inspection-related challenges in particular. FDA expressed agreement with GADA’s proposed fee structure for AGDUFA IV. FDA presented the following hypothetical data models:

• a 2022 fee structure with a complexity factor added for the application fee,
• a workload adjuster without reactivations of manufacturing supplements, including 3-, 4-, and 5-year rolling averages, and
• a workload adjuster with generic investigational new animal drug files and generic investigational meetings, including 3-, 4-, and 5-year rolling averages. 

FDA introduced the concept of supporting the integrity of the approval process. GADA responded with a concern for supporting the funding alone. 

FDA and GADA discussed remaining questions about proposed revisions to the ground rules addressing the treatment of information exchanged during the negotiation process. 

FDA and GADA discussed the goal end date of the negotiations. Acknowledging that the original target of October 1, 2021, was less than a week away, both parties agreed to consider a new target date.

The meeting adjourned at 9:45 a.m.