May 22, 2012 - Updated
ADUFA III Negotiation Meeting Minutes
Animal Health Institute
1325 G St. NW, Suite 700, Washington DC
May 22, 2012
10:00 am – 11:30 am
To continue discussion on FDA and Industry perspectives on ADUFA reauthorization (ADUFA III) financial proposals and review process improvements.
FDA Industry Steve Vaughn, FDA Rich Carnevale, AHI David Wardrop, FDA Bruce Martin, Bayer Roxanne Schweitzer, FDA Chan Baldwin, Abbott Elizabeth Luddy, FDA Grace Gowda, Merial Dennis Bensley, FDA Kathy Vannatta, Elanco Petra Garosi, FDA Sam Veluvolu, AHI Yanming Chae, FDA Tom Schriemer, Pfizer Frank Claunts, FDA Consultant
Industry’s Feedback on ADUFA III Proposed Financial Funding
- Industry provided a financial proposal in response to FDA's financial proposal of March 16, 2012. Included in Industry’s proposal was a variable inflation adjuster. No agreement for funding of ADUFA III was reached at this meeting. FDA asked Industry to respond back by May 25, 2012 with their final funding level proposal in order for FDA to properly prepare for the upcoming June 5, 2012 meeting.
- General agreement around the use of a variable inflation adjuster was accepted. FDA will prepare a counter proposal for both the Inflation Adjuster as well as the financial proposal at a future meeting.
- All other agenda items have been tabled until final base funding agreement has been reached.
Next Meeting Agenda
- To be determined
- June 5 meeting was rescheduled to June 19 to provide both Industry and FDA more time to modify the original financial proposal.