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U.S. Department of Health and Human Services

For Industry

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March 16, 2012

ADUFA III Negotiation Meeting Minutes

Animal Health Institute
1325 G St. NW, Suite 700, Washington DC
March 16, 2012
10:00 am – 3:00 pm


Purpose

To discuss financial proposals from both FDA and Industry, and to continue discussion on FDA and Industry perspectives on ADUFA reauthorization (ADUFA III) and review process improvements.

Participants

 FDA Industry
 Steve Vaughn, CVM Rich Carnevale, AHI
 David Wardrop, CVM Bruce Martin, Bayer
 Roxanne Schweitzer, CVM Chan Baldwin, Abbott
 Elizabeth Luddy, CVM Grace Gowda, Merial
 Dennis Bensley, CVM Kathy Vannatta, Elanco
 Petra Garosi, CVM Sam Veluvolu, AHI
 Yanming Chae, CVM Tom Schriemer, Pfizer
 Frank Claunts, Consultant 

 

Questions from March 6th Meeting

  • AHI shared with FDA that it has certified that they represent the majority of Animal Health Industry for the purposes of renegotiating ADUFA.
  • FDA provided insight that they may be proposing a change to the workload adjuster but indicated at this time that they would need more internal discussions before presenting a final recommendation for change.

Financial Presentation from Industry

  • Industry raised the point of FDA’s appropriation increases in FY 2009 and FY 2010.
  • FDA countered that for FY 2011; the appropriations level has decreased and cited the FY 2011 ADUFA Financial Report to Congress.
  • Industry proposed process improvements and accordingly suggested that these might be necessary in order for it to support funding of the current FTE level.
  • Industry expressed an interest of using variable inflation adjustment for ADUFA III program.

Financial Presentation from FDA

  • FDA’s presentation discussed a sound financial footing for the program, which included options for the inflation adjuster, an appropriation shortfall scenario, and stabilizing the fee revenue stream.
  • In addition, FDA discussed the expected baseline resources for the ADUFA program in FY 2014 – the first year of ADUFA III. This level of resources, from FDA’s perspective, is necessary to continue the current program into ADUFA III without any decrease in current performance expectations.

Note: Both FDA and AHI proposed separate approaches for funding ADUFA reauthorization in FY 2014. Neither FDA nor AHI has agreed on any funding scenarios and further discussion is ongoing.

Industry’s Presentation on Proposed Performance Enhancements for ADUFA III

The industry provided ideas for performance enhancements for ADUFA III. The industry’s ultimate goals to make enhancements that decrease time to approval, provide more flexibility to the industry in submitting amendments, and enhance communication throughout the review process with the Agency. The topic areas presented were as follows:

  • ERA Modifications
  • Shorter Second Round Reviews
  • Reduced Timelines for Certain Submissions
  • Expedited Review
  • CMC Review Improvements

Legislative Change for Minor Use and Minor Species Indexed Products

  • FDA proposed a change in legislation that would revise and clarify the currently required label statement regarding the status of indexed new animal drug products. The industry agreed with the legislative change.

Next Meeting Agenda

  • Follow-up the discussion on the financial proposals
  • AHI’s presentation on long term regulatory changes for:
    • Conditional approvals
    • ADAA combination approvals
    • Greater application of foreign data/joint reviews
  • Follow-up the discussion on workload adjuster
  • FDA’s presentation on proposed ADUFA III performance enhancements