ADUFA V Negotiations Meeting Minutes
December 16, 2021, 9AM – 3PM
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 are planned to run through January 31, 2022, will satisfy the requirement in section 740A(d)(1)(F) of the FD&C Act. The overall purpose of this meeting was for FDA and AHI to continue program enhancement discussions for the ADUFA program and present initial financial package discussions.
Matt Lucia, Center for Veterinary Medicine (CVM)
Roxanne Schweitzer, CVM
Tim Schell, CVM
Julie Bailey, CVM
Chuck Andres, CVM
Cassie Ravo, CVM
Petra Garosi, CVM
Steve Fleischer, CVM
Crystal Groesbeck, CVM
Elizabeth Cash, Office of Chief Counsel (OCC)
Alissa Jijon, OCC
Matt Lockeed, Office of Legislation
Rachel Cumberbatch, Animal Health Institute
Jan Cunningham, Dechra
Grace Gowda, Boehringer-Ingelheim Animal Health
John Hallberg, Zoetis
Gareth Harris, Merck
Alicia Henk, Ceva
Todd Rhodes, Vetoquinol
Kelly Rosenkrans, Elanco
Alan Taylor, Virbac
Kathy Vannatta, Animal Health Institute
Ron Phillips, Animal Health Institute
The meeting began at 9:00 a.m.
FDA presented a proposed ADUFA V package, including programmatic enhancements for the following areas:
- Performance metrics to be included in the annual performance report to Congress
- Timelines for virtual sponsor meetings, including providing feedback on meeting request questions prior to the meeting, if appropriate
- Transparency regarding raw data requirements, including publishing a guidance for industry (GFI) on good clinical practice (GCP) and good laboratory practice (GLP) studies; creating a public document detailing the process for electronic data capture (EDC) for effectiveness studies; and formalizing current pilot on raw data submission during an H submission
- Chemistry, Manufacturing, and Controls (CMC), including enhanced communication through the FDA.gov website, new guidance for FDA staff and industry, to allow for parallel submission of drug substance and drug product information with clear timelines, maintaining business process improvement (BPI) efforts to update current submission tools via eSubmitter
- H Submissions, including new procedures for FDA staff and making them sentinel with an associated performance goal
- A working group to evaluate a “clock stop” procedure to help manage the review timeline of sentinel submissions
FDA proposed a base revenue for ADUFA V FY 2024 (year one). The proposed revenue amount includes all current program work plus the additional program proposals presented above.
FDA provided a proposal for bioresearch monitoring (BIMO) inspection of facilities in lieu of raw data submission and the costs associated with this program enhancement.
AHI asked clarifying questions about FDA’s presentation. AHI inquired about time to set up a virtual vs. in-person meeting. CVM indicated it requires as much time to set up a virtual meeting as a face-to-face meeting due to the need to have an internal pre-meeting and to schedule the necessary staff. It was noted that CVM is already providing their comments to requests pre-meeting. An option discussed was that if agreed with the sponsor pre-meeting, staff from certain areas would not attend and their summaries would be placed in the memorandum of conference (MOC). AHI noted that post pandemic, sponsors still need the ability to request an in-person meeting. AHI had questions about metrics particularly around the granularity of published metrics.
AHI presented their financial proposals. They shared their perspective on the financial pressures and challenges faced by the animal health industry, including market pressures, perceived regulatory uncertainty, and financial risks. AHI presented on product development costs, development and registration times, and data exclusivity protections. Industry provided its perspective on the ADUFA program and the relationship between the program and the pressures and challenges faced by the animal health market. AHI presented its budget philosophy including the importance of a return on investments as measured by time to approval, reduced cycle time, increases in 1st cycle approvals, and leading to an increase in the number of product approvals. AHI proposed a base revenue for ADUFA V. AHI underscored its request for FDA to justify current and future ADUFA fees using supporting data.
AHI proposed areas for change related to financial aspects of ADUFA V, including:
- Base-years change for the workload adjustment
- Carryover balance cap
- Addressing over collections and under collections in the last FY of the program
- Resource reporting
- A new tier-based fee structure to include a small business sponsor fee
- Strategic planning including a third-party assessment of CVM effectiveness and an annual financial planning report
FDA provided comments on, and asked clarifying questions about, AHI’s proposals.
Raw Data Discussion
FDA and AHI agreed to discuss goals letter language addressing the creation of a draft GFI outlining the principles of raw data submitted to support GLP and GCP studies and to include the target date for issuing the draft GFI as part of the ADUFA V goals. FDA and AHI tentatively agreed to formalize the H submission pilot where sponsors can clarify the raw data to be submitted to support the review of target animal safety studies and to expand that pilot to include effectiveness evaluations. FDA and AHI discussed other activities related to providing clarity on the role of raw data in sponsor submissions of final study reports.
H Submission Discussion
FDA and AHI discussed how to provide clarity for both sponsors and reviewers regarding the appropriate timing and content of H submissions.
Chemistry, Manufacturing, and Controls (CMC) Discussion
FDA and AHI discussed a variety of program enhancements for the CMC technical section. FDA and AHI tentatively agreed to the development of a policy & procedures guide (P&P) for FDA reviewers in the Division of Manufacturing Technologies, that addresses use of current administrative tools. FDA and AHI also tentatively agreed to update an existing GFI to allow for parallel submissions of drug substance and drug product information. AHI requested clarification on when industry and FDA could start utilizing parallel submissions relative to the publication of the revised guidance.
FDA and AHI team members agreed to an interim discussion about future program metrics.
Other Program Enhancements
FDA and AHI tentatively agreed to explore a “clock stop” program enhancement to help manage the review timeline. The agency is continuing internal discussions on AHI’s proposals related to residue method trial, import tolerance, and Animal Drug Availability Act of 1996 (ADAA) combinations. Interim discussions will be scheduled to follow up on these topics.
FDA and AHI tentatively agreed to propose a fee technical fix for expanded conditional approval applications that leverage data from fully approved applications.
FDA will respond to AHI’s financial proposals at the next negotiations session, which is scheduled for January 11, 2022. AHI will provide additional detail on the proposal for a tier-based sponsor fee structure.
FDA and AHI agreed to action items and next steps. FDA and AHI team members agreed to informally discuss metrics, residue method trials, and ADAA combination drugs before the next negotiation session. An interim discussion on import tolerance will also be scheduled.
The meeting adjourned at 3:08 pm.