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U.S. Department of Health and Human Services

For Industry

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May 1, 2012

ADUFA III Negotiation Meeting Minutes
Animal Health Institute
1325 G St. NW, Suite 700, Washington DC
May 1, 2012
10:00 am – 3:00 pm


Purpose

To continue discussion on FDA and Industry perspectives on ADUFA reauthorization (ADUFA III) review process improvements.

Participants

FDAIndustry
Steve Vaughn, FDARich Carnevale, AHI
David Wardrop, FDABruce Martin, Bayer
Roxanne Schweitzer, FDAChan Baldwin, Abbott
Elizabeth Luddy, FDAGrace Gowda, Merial
Mai Huynh, FDAKathy Vannatta, Elanco
Petra Garosi, FDASam Veluvolu, AHI
Marty Schoenemann, FDATom Schriemer, Pfizer
Yanming Chae, FDA 

 

Follow-Up Discussion on March 16, 2012 Meeting Minutes

The March 16, 2012 minutes have been amended to reflect conversations held by both parties and agreed to at this meeting.

Expedited Review

Industry was interested in continued exploration of expedited review. FDA stated that with the current efficiencies the expedited review procedures would not accelerate time to approval. Industry suggested limiting the scope of expedited review to the last data submission of a phase review project. FDA stated that they would explore that option.

Additional Negotiation Meetings

Two additional negotiation meetings were added to the schedule – June 5, 2012 and June 19, 2012.

Short Term Performance Changes – Continued Discussion

Industry responded to FDA’s proposals from the April 10th negotiation meeting. FDA noted that any discussions and subsequent agreements with performance changes are dependent on FDA acquiring full funding for ADUFA III to maintain ADUFA II performance levels. Having no agreement on the funding agreements, no performance agreements were reached.

Industry’s Long Term Changes Proposal – Continued Discussion

  • Conditional Approvals
    • No agreement was reached at this point. FDA will explore further options.
  • ADAA Combinations
    • No agreement was reached at this point. FDA will explore further options.
  • Greater Application of Foreign Data
    • Industry will present a specific proposal at the next meeting.

Industry Feedback on the Workload Adjuster

Agreement was reached on modifying the Workload Adjustor (WA) by moving the base years for calculating the WA to the five previous years (e.g., ADUFA II). Industry and FDA agreed to maintain the existing sentinel submissions, and to ensure consistency in the accounting of submissions if processes changes are agreed to between ADUFA II and ADUFA III.

Next Meeting Agenda

  • Industry’s feedback on FDA’s financial proposal
  • Continued discussions on short-term process improvements
  • FDA’s response to expedited review for the last data submission of a phased review project
  • Further discussions on long-term process changes
    • Industry’s proposal on greater application of foreign data
    • FDA’s response to the ADAA combo proposal from Industry
    • FDA’s response to the conditional approval proposal from Industry