For Industry

June 19, 2012

ADUFA III Negotiation Meeting Minutes
Animal Health Institute
1325 G St. NW, Suite 700, Washington DC
June 19, 2012
10:00 am – 3:00 pm

Purpose

To continue discussion on ADUFA reauthorization (ADUFA III).

Participants

FDAIndustry
Steve Vaughn, FDARich Carnevale, AHI
David Wardrop, FDABruce Martin, Bayer
Roxanne Schweitzer, FDAChan Baldwin, Abbott
Elizabeth Luddy, FDAKathy Vannatta, Elanco
Dennis Bensley, FDASam Veluvolu, AHI
Petra Garosi, FDA (via phone)Tom Schriemer, Pfizer
Yanming Chae, FDA 
Frank Claunts, FDA Consultant 

FDA’s Financial Counter Proposal

  • FDA and Industry have agreed in principle with an annual inflation adjuster.
  • FDA and Industry have agreed in principle for funding for ADUFA III.

Continued Discussion on Performance Enhancements

  • FDA and Industry continued discussions on the following performance enhancements:
    • FDA will replace the end-review amendment process with shortened reactivation/resubmission review times for original new animal drug applications (NADAs), non-manufacturing supplements, investigation new animal drug (INAD) data submissions, and INAD protocols without data.
    • FDA will allow short justifications in INAD protocols without data and the concurrent submission of supporting data and INAD protocols predicated on the sponsor submitting information/data early in the new animal drug development process. FDA will allow for the inclusion of this early information/data in presubmission conference requests.
    • FDA will allow for a shorter review clock on microbial food safety hazard characterization.
    • FDA will review certain prior approval labeling supplements in less than 180 days.
    • FDA will allow for certain reactivations of Prior Approval Supplements as a 30-day Chemistry Manufacturing Controls (CMC) Changes Being Effected (CBE) supplement, comparability protocols under INADs, and a two-phased CMC technical section review process.
    • FDA provided proposed ADUFA III performance goals language to explore the feasibility of pursuing statutory revisions to expand the use of conditional approval and to modify the current requirement that the use of multiple new animal drugs in the same medicated feed be subject to an approved application.
  • FDA commented that the performance enhancements discussed above would have associated IT costs and that FDA would provide an estimate prior to the next meeting.
  • FDA and Industry discussed concerns from stakeholders regarding the extent of antibacterial drug use in food-producing animals. FDA expressed a desire to have Industry support the soliciting of input from all stakeholders and other government agencies on ways to improve the collection of usage data on, in particular, medically important antibiotics in food animals. Industry stated their general support for the further study of this issue, independent of the ADUFA reauthorization, so as to put animal antibiotic use into proper context.

Future Meetings

  • Two additional negotiation meetings were added to the schedule – July 10, 2012 and July 24, 2012.

Next Meeting Agenda

  • Discuss ADUFA III Funding
    • Fee Distribution Structure
    • IT Costs
  • Review and Discuss the Proposed ADUFA III Legislation and Performance Goals Letter