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November 9, 2016 Meeting Minutes

November 9, 2016 Meeting Minutes

AGDUFA III Negotiations with Industry
November 9, 2016
9:00 a.m. – 1:45 p.m.
FDA, Metro Park North, Rockville, MD


Purpose

The overall purpose of the meeting was to discuss Industry’s response to FDA financial proposals from previous meeting.

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
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.
Randy McCallum, Sparhawk Labs
David Zorn, Consultant to GADA
Ted Sullivan, GADA Legal Counsel
Kathy DeMarco, GADA Executive Director

Industry Presentation

GADA’s presentation addressed FDA’s financial proposals from the October 18, 2016 meeting and GADA’s responses to those proposals, including:

  • Workload Adjuster: GADA and FDA discussed leaving the Workload Adjuster as is, with the exception of resetting the base years from FY 2009-2013 to FY 2014-2018.
  • Change to the Process Trigger: discussion continued on the impact of not changing the current trigger. GADA and FDA agreed to continue discussion and postpone a decision until a future meeting.
  • Elimination of the Offset Provision: FDA provided some additional information at GADA’s request. GADA and FDA agreed to continue discussion and postpone a decision until a future meeting.
  • Changes to the Fee Structure Proposal: Industry is considering restructuring fees and will be prepared to make recommendations at the December 14, 2016 meeting.

Additional topics covered by Industry’s presentation included:

  • The amendment process for generic animal drug related submissions which GADA and FDA agreed to further discuss at the GADA quarterly meeting.
  • GADA’s counter proposal that e-Submissions be required beginning in FY 2021, instead of FY 2019, due to associated challenges.
  • GADA’s counter proposal for funding, decreasing CVM’s proposed cost by approximately $5 million.
    • CVM counter proposed for the decreased revenue amount: increased review times for ANADA original/reactivations and JINAD data submissions by 60 days from 180 days to 210 days.

FDA Presentation

FDA’s presentation on Variable Inflation Adjuster proposes to change the current fixed inflation adjuster (AGDUFA ll is currently at a fixed 4% annualized inflation adjuster) to a variable inflation adjuster (similar to what is in place for ADUFA and PDUFA). FDA believes this is a win-win situation, providing the program with current inflationary increases to meet current costs. No decision was made at this time.

Additional Meeting

FDA and Industry agreed to add Wednesday, January 25, 2017 as an additional negotiation meeting.

Next Agenda – December 14, 2016

FDA and Industry agreed to continue discussion on today’s topics, with the addition of hearing Industry’s thoughts on compounding.