AGDUFA III Negotiations with Industry
August 10, 2016
FDA, Metro Park North, Rockville, MD
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 III. For the AGDUFA III 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 2016, 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 III.
Roxanne Schweitzer, Center for Veterinary Medicine (CVM)
Steve Vaughn, CVM
Cassie Ravo, CVM
David Wardrop, CVM
Beth Luddy, CVM
Chuck Andres, CVM
Dennis Bensley, Jr., CVM
Petra Garosi, CVM
Charli Long, CVM
Matt Lucia, CVM
Julie Bailey, CVM
Sharon Tarbell, CVM
Ruth Watson, Office of Legislation
Lori Talley, Office of Chief Counsel (OCC)
Elizabeth Cash, (OCC)
Industry: Generic Animal Drug Alliance (GADA)
Bill Zollers, Norbrook, Inc.
Herschel Gaddy, HJ Gaddy Associates
Jodi Beaudry, Bimeda
Randy McCallum, Sparhawk Labs
Gerald Macedo, Med-Pharmex, Inc.
Alicia Henk, Ceva Animal Health
Ted Sullivan, GADA Legal Counsel
Kathy DeMarco, GADA Executive Director
The meeting began at 12:00 p.m.
Introduction of FDA and GADA Participants
Recognition of Negotiating Leads
- FDA: Roxanne Schweitzer and Steve Vaughn
- GADA: Bill Zollers and Doug Rupp
GADA’s Letter of Assurance of Representation of Majority of Industry
- GADA had previously shared written confirmation with FDA that it represents a majority of the generic animal drug industry. GADA reaffirmed this representation verbally at the meeting.
- The ground rules that will govern AGDUFA III negotiations were discussed and agreed to by both FDA and Industry with one minor modification.
Industry Perspective on AGDUFA III
- GADA briefly discussed their areas of concern including reduction of submission review time, pursuit of a legislative change enabling ANADA approvals for a single species from an reference listed new animal drug (RLNAD) where multiple species is approved; an in vitro dissolution pathway for generic animal drugs to replace the requirement for a demonstration of in vivo bioequivalence to RLNADs; the extent to which Type A combination approvals impact the workload adjuster, how sentinel submissions impact the workload adjuster; how the carry-over balance is generated and calculated and how it will impact AGDUFA III costs; if the formula for the workload adjuster calculation causes a reduction in user fee revenue if CVM’s workload decreases; improving communication between sponsors and CVM during application review; GADA membership’s lack of support for CVM project management functions for generic drugs; the trend toward increasing requirements for application approvals particularly USP standards; competition from unapproved compounded animal drugs; API sponsors maintaining current API master files; and whether and how e-Submitter improves the review process.
FDA Perspectives on AGDUFA III
- FDA’s presentation discussed two over-arching objectives: smart/sustainable long-term financial planning and ensuring predictable and sustained revenue to have the capacity to meet and exceed performance goals and to continue to invest in quality program improvements. Topics included AGDUFA I and II performance, benefits to industry resulting from AGDUFA (such as decreased submission review time), and potential enhancements to existing financial requirements to enable long-term financial planning and predictable and sustainable revenue. Additional presentations included high-level overviews of the carry-over balance and the workload adjuster.
Establishment of Future Agendas
- FDA and Industry discussed the topics for the next meeting on September 14, 2016.
The meeting adjourned at 3:15 p.m.