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February 7, 2017 Meeting Minutes

February 7, 2017 Meeting Minutes

ADUFA Negotiations with Industry
February 7, 2017
9:00 a.m. – 11:35 a.m.
Rockville, MD


Purpose

The overall purpose of the meeting was to continue discussion on financial proposals and proposed program enhancements.

Participants

FDA

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
Julie Bailey, CVM
Sharon Tarbell, CVM
Linda Walter-Grimm, CVM
Jill Adleberg, Office of Legislation
Lori Talley, Office of Chief Counsel

Industry: Animal Health Institute (AHI)

Rich Carnevale, AHI
Grace Gowda, Merial
Chan Baldwin, Zoetis
Todd Rhodes, Bayer
Kathy Vannatta, Elanco
Kelly Klaus, AHI

FDA’s ADUFA IV Package

FDA distributed to the Industry negotiating team a document describing the justification for the Agency’s request for increased resources to sustain performance, including the internal and external factors that impact the program, as discussed at the January 24, 2017 meeting.

In addition to previously discussed proposals, the total package proposed by FDA for ADUFA IV includes certain post-market activities, including pharmacovigilance and import tolerance, as well as technical corrections to the Federal Food, Drug, and Cosmetic Act including the section on animal drug indexing (labeling correction), use of user fees for activities relating to current conditional approval, publication of approvals on the Internet, and use of user fees for Freedom of Information Act activities. Additionally, FDA proposed including an exploratory goal for the next reauthorization negotiations (ADUFA V) on a more comprehensive approach to funding the full-life cycle of the animal drug program (pre- and post-market).

AHI acknowledged FDA’s efforts to justify their increased resource request, but because industry is not able to support any increase in funding without program enhancements (such as the expansion of conditional approval), AHI proposed to withdraw all previously discussed program enhancements and revert to ADUFA III funding and performance standards.

FDA and AHI continued discussion on previously discussed program enhancements, including ADAA combos, categorical exclusions, memoranda of conferences, tissue residue, review transparency, and common submission issues.

FDA and AHI did not reach any agreements.

Topics for future agenda to be determined.