AGDUFA IV Negotiations with Industry
July 14, 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. This was the initial meeting. The overall purpose of the meeting was to discuss meeting ground rules and logistics, to develop a plan for the negotiation process, and to allow FDA and GADA to deliver their initial perspectives on AGDUFA IV.
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
Elizabeth Cash, Office of Chief Counsel (OCC)
Alissa Jijon, OCC
Matt Lockeed, Office of Legislation (OL)
Industry: Generic Animal Drug Alliance (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) Headquarters
Ted Sullivan, GADA Legal Counsel
The meeting began at 9:00 AM. This is the first negotiation session of AGDUFA IV.
Recognitions of FDA and GADA Leads
- Matt Lucia, Roxanne Schweitzer, and Tim Schell recognized as FDA lead negotiators.
- Stephanie Batliner and Ben Moses recognized as GADA lead negotiators.
Introduction of FDA and GADA Participants
Ground Rules (including norms for virtual and hybrid sessions)
The ground rules that will govern AGDUFA IV negotiations were discussed. There was a discussion about the scope and duration of the ground rules during the reauthorization process, including what aspects of the regulatory process can be included in negotiations and what time period the ground rules cover, which will be discussed further at the next meeting.
Industry Perspective on AGDUFA IV
GADA discussed their vision and goals for the user fee program and areas of concern for the current program. GADA’s goal is to collaborate with FDA CVM to implement enhancements to a functional user fee program that supports an efficient FDA review and a predictable and timely approval process that fosters public health by increasing the availability of high quality, safe and effective, low-cost, FDA-approved generic animal drugs. This AGDUFA user fee program must employ a cost-effective and equitable payment structure to support a highly competitive marketplace for generic animal drug companies small and large.
Concerns include the increasing workload; carryover balance; the observation that user fee spending funds a larger percentage of the AGDUFA program than is the case for the Animal Drug User Fee Act (ADUFA), contributing to the view that the generics industry is funding their own growth; more clarity needed on Budget Authority spending vs User Fee spending; and that there should be a more equitable fee structure. They expressed that some GADA members believe the current AGDUFA fee structure does not strike the appropriate balance between small and large companies. GADA is also concerned the workload is being driven by submissions that ultimately do not result in approved abbreviated new animal drug applications (ANADAs), and that the increase in workload is not resulting in additional sponsors being subject to AGDUFA fees. GADA also shared a continued concern over the impact of illegal pharmacy compounding on the generic animal drug industry. GADA believes that as AGDUFA program fees increase, particularly the application fee, companies will only pursue the most lucrative products, leaving the public with fewer drug options, and an underserved animal health need.
FDA Perspective on AGDUFA IV
FDA discussed their vision and goals for the user fee program and reauthorization, the benefits of AGDUFA, and a financial overview. FDA’s goal for the AGDUFA IV reauthorization is to promote and protect human and animal health by having the capacity to meet performance goals and continuing to invest in program improvements using a lifecycle approach by ensuring a predictable review process through sustained revenue. FDA’s presentation described a number of benefits of the AGDUFA program, including having predictable review timelines; an increase in generic drug approvals; receiving nearly 100% electronic submissions; stakeholder collaboration and transparency; Chemistry, Manufacturing, and Control (CMC) process improvements; and enhancements to Veterinary Master Files (VMFs). FDA’s financial presentation discussed the AGDUFA program process costs, workload adjuster, and carryover.
Establishment of Future Agendas
FDA and Industry discussed action items from this meeting and the topics for the next meeting on July 22, 2021.
The meeting adjourned at 12:50 PM.