ADUFA V Negotiations Meeting Minutes
May 5, 2022, 3PM – 5PM
Section 740A(d)(1)(F) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with representatives of the regulated industry to negotiate recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA) program, ADUFA V. For the ADUFA negotiations, regulated industry is represented by the Animal Health Institute (AHI). FDA’s meetings with AHI, which tentatively were planned to run through February 28, 2022, and are still ongoing, will satisfy the requirement in section 740A(d)(1)(F) of the FD&C Act. The overall purpose of this meeting was for AHI to present a counterproposal and for FDA and AHI to discuss the proposals and develop a strategy for concluding negotiations.
Matt Lucia, Center for Veterinary Medicine (CVM)
Roxanne Schweitzer, CVM
Tim Schell, CVM
Julie Bailey, CVM
Chuck Andres, CVM
Cassie Ravo, CVM
Lisa Kable, CVM
Petra Garosi, CVM
Steve Fleischer, CVM
Elizabeth Cash, Office of Chief Counsel (OCC)
Rachel Cumberbatch, Animal Health Institute
Grace Gowda, Boehringer-Ingelheim Animal Health
Mary Hagler, Dechra
Gareth Harris, Merck
Alicia Henk, Ceva
Todd Rhodes, Vetoquinol
Kelly Rosenkrans, Elanco
Alan Taylor, Virbac
John Hallberg, Zoetis
Kathy Vannatta, Animal Health Institute
Ron Phillips, Animal Health Institute
The meeting began at 3:00 p.m.
FDA briefly showed an example of what the 5-year financial plan report would look like.
FDA and AHI reviewed areas for which the parties have reached tentative agreement:
- P submission at Division Level
- H Submissions
- Third Party Assessment
- Mutual Recognition Agreements (MRA)
- Inclusion of UK
- Inclusion of a metric
- Raw Data: Guidance for Industry (GFI)
- Chemistry, Manufacturing, and Controls section of New Animal Drug Applications (NADA)
- Policy & Procedures (P&P) Manual document
- Goals Letter language for discussion in ADUFA V on:
- Clock stop procedure
- Residue method trials
- ADAA combination animal drug reviews
- 5-year financial plan
- The parties confirmed that the format of the financial report will parallel that of the PDUFA “Five-Year Financial Plan, Fiscal Years 2018-2019-2020-2021-2022, FY 2021 Update.”
- Technical fix for certain extended conditional approval applications
For programmatic enhancements, the rest of the meeting focused on areas for which additional discussions and agreements were still needed. These programmatic areas included:
- Because of the importance of metrics to AHI, they proposed that metric reporting should begin prior to the finalization of the third-party assessment, which includes a metrics study.
- Metrics reported would be related to first-pass favorable outcomes for E (protocol) and P (technical section) submissions and time in agency/time in industry. Pending the outcome of the third-party assessment metrics study and any conclusions drawn from any metrics reported prior to the third-party assessment, AHI proposed that the next steps would be to examine whether CVM can update its IT systems to track favorable outcomes by cycle.
- As part of the discussion on metrics that measure the time in agency and time with the sponsor during the investigational phase, AHI asked about determination of time in agency for patent term restoration. FDA reported that this is driven by the U.S. Patent and Trademark Office and discussed FDA’s role (with the U.S. Patent and Trademark Office) in the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) calculations of periods of patent extension.
- H submissions for: meeting requests, reporting of raw data, and protocol submissions:
- For H submissions in support of a meeting request, the proposed draft goals letter language was accepted.
- For H submissions to support protocol review, discussion revolved around having FDA clarify when a protocol could be submitted after an H submission. It was noted that P&P 1243.2200 does provide some additional information. FDA agreed that the revised P&P will include clarification on when a protocol may “or may not” be submitted at Day 50 of the H Submission review timeframe.
- For H submissions reporting raw data, the parties discussed the timing for completion of P&P sections on target animal safety data and effectiveness data. FDA explained that a submission template and implementation of the process for target animal safety data submission would be completed two years prior to finalization of the process for effectiveness data submission. FDA further explained that the process would use new E-submitter templates and the draft templates would be shared with the industry E-submitter working group prior to finalization. AHI emphasized that industry did not support question-based review (QbR) and questioned what the templates would look like and their use. FDA noted that they have tentatively agreed to the publication of a draft GFI on raw data due at the end of year one of ADUFA V that may modify this H submission proposal further.
- Programmatic enhancements for virtual pre-submission conference (PSC) meetings:
- AHI and FDA reached tentative agreement on the deadline for written feedback prior to a scheduled meeting.
- Goals letter language to explore during ADUFA V additional ways for FDA to provide efficient and effective feedback on a sponsor’s animal drug development plan
- CVM leadership engagement during triannual meetings between industry and CVM
- Joint educational opportunities for FDA staff and animal drug industry stakeholders
- AHI presented financial proposals for a carryover cap minimum and maximum, changes to the current workload adjuster, and proposed base funding for the first year of ADUFA V.
- FDA and industry have reached tentative agreement on changes to the workload adjuster.
- With regard to the carryover balance, AHI proposed a 14-week cap and a 10-week minimum. FDA indicated that a 12-week carryover balance is the current minimum needed for the program and an acceptable cap would be 16 weeks. AHI pointed out the difference between this proposed cap and those used in the other user fee programs. FDA explained its perspective that the smaller size of the ADUFA program justifies the higher cap.
- AHI’s evaluation is that none of the proposed enhancements would require adding to the base funding of the program. The parties agree that certain costs (e.g., the third-party assessment) would come from carryover rather than being added to the base funding.
- AHI’s evaluation is that over the past four years, the target revenue for the program has exceeded the expenditures by over $5 million with an average inflation adjustment of under 2%. The total annual expenditures for the program have risen by an average of 3% over that same 4-year period.
- AHI presented their proposal for the ADUFA V base.
- FDA explained that carry-over would be used to hire 5 FTEs to support the anticipated work due to the tentatively agreed to enhancements from the current negotiations. FDA does not view these additional employees as part of the base program cost.
- Industry agreed to take back what FDA shared on AHI’s proposals and discuss at the next negotiation session. FDA will provide its talking points from the negotiation sessions to AHI in writing.
FDA agreed to provide AHI the presented financial comments in writing.
FDA and AHI reviewed action items and agreed to continue discussions on these outstanding topics electronically. The parties did not make a plan for concluding negotiations.
FDA to review dates for the various working groups and initiatives to ensure that it is not overcommitting itself in the first couple years of the program.
The meeting adjourned at 5:10 PM.