AGDUFA III Negotiations with Industry
January 25, 2017
9:00 a.m. – 1:45 p.m.
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 the current meeting, will satisfy the requirement in section 742(d)(1)(F) of the FD&C Act. The overall purpose of the meeting was to finalize 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
Sharon Tarbell, CVM
Margaret Zabriski, CVM
Jill Adleberg, 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
Alicia Henk, Ceva Animal Health
Gerald Macedo, Med-Pharmex, Inc.
Ted Sullivan, GADA Legal Counsel
Randy McCallum, Sparhawk Labs
Kathy DeMarco, GADA Executive Director
The FDA and GADA negotiating teams have reached tentative agreement on a total funding package for AGDUFA III, and proposals for the fee structure, inflation adjuster, offset provision, and workload adjuster.
Program Changes or Enhancements
Additional changes and/or enhancements were agreed to by the FDA and GADA negotiating teams including changes to performance goals and requiring electronic submissions. There was also agreement to recommend amending § 741(k)(10) to include processing of FOIA requests relating to application review.
The FDA and GADA negotiating teams will share the package and agreements with their respective ratifiers.
No further meetings are scheduled as of now.