ADUFA V Negotiations Meeting Minutes
February 3, 2022, 10AM – 2PM
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 February 28, 2022, 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 their counter proposal and for FDA and AHI to discuss programmatic and financial enhancements to the ADUFA program.
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
Crystal Groesbeck, CVM
Elizabeth Cash, Office of Chief Counsel (OCC)
Alissa Jijon, OCC
Matt Lockeed, Office of Legislation
Rachel Cumberbatch, Animal Health Institute
Grace Gowda, Boehringer-Ingelheim Animal Health
John Hallberg, Zoetis
Mary Hagler, Dechra
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 10:00 a.m.
AHI presented its counter proposal to FDA’s December 16, 2021, meeting presentation. The parties discussed topics contained in the presentation. AHI’s presentation expressed continued support for those items previously agreed to. It also included:
- A proposal to re-establish the F submission to review protocols with data
- A recommendation to allow an additional submission pathway for raw data
- A request for clarification of the intent of certain chemistry, manufacturing, and controls (CMC) enhancements proposed by FDA
- A proposal to reinstitute industry-CVM meetings for sharing progress, metrics, and outcome-focused measures (time in agency, robustness of the new animal drug pipeline, and first cycle favorable outcomes)
- An alternative to FDA’s meetings proposal, to include feedback in advance of meetings
- Proposed modification of goals letter language to explore enhancements related to Residue Method Trials and ADAA combinations
- Responding to a past question from CVM, AHI proposed that language on the EU-US GMP mutual recognition agreement (MRA) not be added to the ADUFA V goals letter since it was already captured under ADUFA IV.
- CVM commented on the advantages of using MRA data to assist in the completion of the CMC technical section review. CVM provided examples where the availability of this information was sufficient to make a pre-approval inspection (PAI) unnecessary. CVM stated that if the MRA was not designated as a permissible activity on which ADUFA funds could be spent, they would rely only on their own inspections, which could delay approvals.
- AHI requested clarification on the resources allocated to the MRA and requested clarification on whether this item needed to be included in the goals letter to be an allowable activity.
- Proposals for the workload adjuster (trigger and cap), carryover balance (minimum and maximum), and elimination of the recovery of collection shortfalls provision
- Agreement not to pursue the topics of import tolerances or a change in the sponsor fee structure as part of the ADUFA V negotiation process
- Emphasis on the importance of a third-party assessment of the ADUFA program
- Proposal on the program cost
FDA provided feedback on each of AHI’s programmatic proposals.
FDA Meeting Proposal
FDA presented an updated version of its proposal for FDA-industry meetings under ADUFA V, including a moving clock date of five days before the meeting date for CVM to issue its evaluation letter and a time limit on virtual pre-submission conferences (PSCs).
AHI provided feedback on FDA’s meeting proposal, emphasizing the desire to include in-person meetings as sentinel submissions. AHI indicated its view that in-person meetings between CVM and sponsors remain important.
FDA Third-Party Assessment Proposal
Building on interim communications between the parties, FDA presented its latest proposal for a third-party assessment of the ADUFA program. FDA proposed to engage an independent, outside consultant to conduct a retrospective analysis of the utilization and effectiveness of the process enhancements of the ADUFA program and other currently available tools and processes used by FDA and industry to increase the likelihood of favorable first cycle review outcomes of data submissions and protocol review submissions.
AHI asked clarifying questions regarding FDA’s third-party assessment proposal. While there is currently agreement on the need for an assessment, discussion continued on the scope of the project. AHI proposed a comprehensive evaluation of the program assessing the congressional finding, proposed outcome metrics, and evaluation of resource utilization including both funding and FTE time. CVM recommended a scope focused on analysis of process enhancements of the ADUFA program and other currently available tools and processes used by FDA and industry to increase the likelihood of favorable first cycle review outcomes of data submissions and protocol review submissions. Both parties expressed openness to having a third party provide recommendations for improvements. AHI pressed for industry and CVM to propose metrics to be evaluated during the third-party assessment. Industry explained its view that providing metrics recommended by experts in the animal drug approval process would increase likelihood of a usable outcome from that portion of the evaluation. CVM pressed for a third party to recommend metrics based on the results of the assessment. FDA and AHI agreed to work electronically on the language describing the third-party assessment.
FDA asked for more context regarding AHI’s proposed workload adjuster cap. FDA provided general comments about AHI’s financial proposal. FDA and AHI agreed to discuss the financial proposal internally and to have further dialogue during an interim discussion.
FDA and AHI agreed to work electronically on language describing program enhancements, including the third-party assessment, F submissions, PSCs, ADAA combinations, and residue methods. FDA and AHI team members will schedule an interim discussion of the financial proposal. CVM committed to providing a more precise request on MRA spending and meetings. AHI agreed to craft and share a more detailed description of the third-party assessment.
The meeting adjourned at 1:48 pm.