ADUFA Negotiations with Industry
January 24, 2017
9:00 a.m. – 2:15 p.m.
The overall purpose of the meeting was to continue discussion on financial proposals and proposed program enhancements.
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
Cindy Burnsteel, CVM
Julie Bailey, CVM
Sharon Tarbell, CVM
Jill Adleberg, Office of Legislation
Lori Talley, Office of Chief Counsel
Industry: Animal Health Institute (AHI)
Rich Carnevale, AHI
Grace Gowda, Merial
Beth Norton, BIVI
Gareth Harris, Merck
Chan Baldwin, Zoetis
Todd Rhodes, Bayer
Kathy Vannatta, Elanco
Kelly Klaus, AHI
At the January 10, 2017 meeting, FDA responded to AHI’s enhancement proposals. At today’s meeting, AHI and FDA continued in-depth discussions to better understand changes that would be most impactful. FDA conveyed they would not be able to add enhancements to Foreign Inspections, Phased Chemistry, Manufacturing and Control (CMC) Submissions, or provide for Shortened Review Times for Administrative NADAs as proposed by AHI. FDA explained that these processes already are as efficient as possible without increasing funding. FDA indicated there had been no change in the status of the Conditional Approval proposal since the previous meeting. FDA informed AHI that the topic of Marketing Exclusivity was beyond the scope of the user fee negotiations.
AHI and FDA discussed financial proposals that previously were proposed by FDA.
- Elimination of the Offset Provision: AHI did not fully support FDA’s proposal to eliminate the Offset Provision. Instead, AHI suggested applying the prior year’s over-collected fees, if any, to fund increases resulting from the Workload Adjuster (WA) calculation, while retaining the ability to offset any remaining over-collected fees in the fifth year. FDA accepted applying over-collected fees from the prior fiscal year to fund increases resulting from the WA calculation. However, FDA countered that any remaining funds after the WA calculation be made available and targeted for new animal drug review and associated activities. AHI will review FDA’s counter proposal.
- Inflation Adjuster: FDA withdrew its proposal.
- Tiered Sponsor and Barrier to Innovation Waiver: FDA withdrew its proposal.
- Fee Structure: FDA and AHI agreed to keep ADUFA III percent of revenue to be derived from each of the different fee types consistent into ADUFA IV.
AHI and FDA continued discussion of the following proposals:
- ADAA Combinations: AHI and CVM are aligned on this proposal; CVM will revise the previously-circulated proposal to reflect AHI’s minor revisions.
- MOC: AHI presented a counter-proposal, applying a metric to the scheduling of meetings;
- Phased CMC: AHI will provide draft language for a long-term ADUFA goal for discussion at the next meeting.
Justification for Increased Resources to Sustain Performance
At the January 10, 2017 meeting, AHI requested more information on FDA’s proposed total package for ADUFA IV, specifically what would be the impact on performance goals and review timeframes without additional funding, and what are the specific changes that have caused a need to increase funding since ADUFA III?
FDA’s presentation discussed the justification for increased resources to sustain performance, including the internal and external factors that impact the program. FDA shared information on the impact of not receiving additional funding on performance review timeframes.
AHI will review the information and respond at a future meeting.
Topics for future agenda to be determined.