April 10, 2012
ADUFA III Negotiation Meeting Minutes
Animal Health Institute
1325 G St. NW, Suite 700, Washington DC
April 10, 2012
10:00 am – 3:00 pm
To continue the discussion on FDA and Industry perspectives on ADUFA reauthorization (ADUFA III) financial proposals and review process improvements.
|Steve Vaughn, CVM||Rich Carenvale, 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|
|Alexis Nazario-Negron, OFM|
|Frank Claunts, Consultant|
Follow-Up the Discussion on the Financial Proposals
- FDA presented to AHI additional financial information responding to AHI’s questions about FTEs and FDA’s appropriations.
- AHI did not have any additional questions regarding FDA’s financial presentation at the time of the meeting. AHI requested additional time to review the supplemental financial materials provided by FDA on April 4, 2012.
AHI’s Presentation on Long Term Regulatory Changes
- AHI proposed long term regulatory changes related to three areas:
- Conditional approvals
- ADAA combination approvals
- Greater application of foreign data/ reviews
- FDA provided general comments on these proposals and agreed to discuss the proposals with the Agency’s general counsel and policy staff in order to provided AHI with additional feedback.
FDA’s Follow-Up Presentation on the ADUFA Workload Adjuster
- FDA presented models of workload adjusters, amending the methodology, which would have been applicable in ADUFA II had the base years been moved (following the PDUFA model) and end-review amendments (ERAs) been added to the workload counts. FDA proposed using such methodology in the models for the ADUFA III workload adjuster. AHI generally agreed with the workload adjuster proposal and agreed to provide a definitive answer to FDA at the next negotiating session.
FDA’s Proposed Topics for ADUFA III Performance Enhancements
- FDA presented its proposal for performance enhancements that would be mostly revenue neutral under the assumption that the financial package for ADUFA III base program as previously presented by FDA would be accepted by AHI.
- The overarching goals for the performance enhancements were to:
- Be mostly resource neutral, and may have some IT costs;
- Leverage existing systems or processes to minimize additional costs;
- Increase flexibility in the review process toward a reduced overall time to approval; and
- Be administratively practical.
- Areas for enhancements included:
- Reduced timelines for resubmissions of certain submission types – protocols, data submissions, non-manufacturing supplements, and original NADAs;
- Reduced timelines for certain submission types – H submissions, categorical exclusions, dosage characterization, non-fee labeling supplements, and microbial food safety hazard characterization;
- CMC improvements – INAD comparability protocols, CBE30 process for certain reactivated prior approval CMC supplements, and two-phased CMC technical section; and
- Expedited review. FDA did not agree to AHI’s previously presented expedited review proposal. Rather, FDA proposed making systemic improvements that would positively affect all applications.
Next Meeting Agenda
- The April 17th, 2012 meeting was canceled in order to give AHI more time to consider FDA’s financial proposal and short term performance changes.
- The agenda for the May 1st, 2012 negotiations meeting will be set at a future date.