AGDUFA III Negotiations with Industry
December 14, 2016
9:00 a.m. – 1:30 p.m.
FDA, Metro Park North, Rockville, MD
The overall purpose of the meeting was to continue discussion on financial proposals and program enhancements.
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
Matt Lucia, CVM
Julie Bailey, CVM
Charli Long, CVM
Sharon Tarbell, CVM
Ruth Watson, Office of Legislation
Elizabeth Cash, Office of Chief Counsel
Industry: Generic Animal Drug Alliance (GADA)
Doug Rupp, Pharmgate, LLC.
Bill Zollers, Norbrook, Inc.
Herschel Gaddy, HJ Gaddy Associates
Jodi Beaudry, Bimeda Inc.
Alicia Henk, Ceva Animal Health
Gerald Macedo, Med-Pharmex, Inc.
David Zorn, Consultant to GADA
Ted Sullivan, GADA Legal Counsel
Kathy DeMarco, GADA Executive Director
GADA’s first presentation was information on total annual sales estimates for proprietary and generic veterinary products.
GADA’s second presentation addressed previously discussed proposals; certain facets of the proposals have been tentatively agreed to by GADA, but final details are still under consideration. GADA will be meeting with their membership to present their current position on the topics discussed. Those topics include: AGDUFA III base funding, performance/review times, the offset provision, the workload adjuster, the inflation adjuster, e-Submissions, and the submission amendment process.
GADA presented a new fee structure proposal that included restructuring the sponsor fee, adding a new fee, and restructuring the ANADA application fee.
As requested by industry at the previous meeting, FDA provided additional information about e-Submissions, explaining the percentages of submissions that are paper versus electronic.
Also, as discussed at the previous meeting, FDA provided an alternative fee structure proposal with various scenarios, including adding a fourth fee for marketed ANADAs and adjusting the percent of revenue derived from each fee category. During discussion of the fee structures, an additional, impromptu recommendation to consider dosage forms as an addition tier for the application fee was put forward by both sides and will be further considered by both FDA and GADA. Both sides agreed to table discussion on fee structure until the next meeting.
GADA and FDA are scheduled to meet on January 25, 2017. Agreements on proposals are expected to be finalized at that time.