AGDUFA IV Negotiations Meeting Minutes
October 21, 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 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 FDA and GADA to review the latest proposal and identify areas of agreement and those requiring further discussion.
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
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.
Discussion of Latest Proposal
The FDA and GADA negotiating teams have reached tentative agreement on a user fee program package for AGDUFA IV, including agreements on the total fee revenue amount, performance goals, the workload adjuster, the fee structure, and the addition of a new shortfall provision. Areas that have been discussed but not quite finalized include premarket enhancements, a proposal to support the integrity of the approval process, and a legislative proposal.
Conclusion of Negotiation Meetings
FDA and GADA anticipate that no further negotiation meetings will be necessary to resolve the remaining discussion items which will be finalized via email and phone calls before FDA and GADA share the package of negotiated recommendations with their respective ratifiers. No new substantive proposals, significant controversies, or differences of opinion were discussed at this meeting.
The meeting adjourned at 12:30 p.m.