ADUFA V Negotiations Meeting Minutes
January 11, 2022, 9AM – 3PM
Format: Virtual

Purpose

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. 

Participants

FDA

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

AHI

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. 

Metrics

AHI previously provided a presentation on proposed metrics.  An interim session was held to continue discussion and to seek further clarity on the proposed metrics. In this negotiation meeting, FDA provided additional feedback after considering the discussion from the interim session and both parties clarified their positions. 

AHI continued to state the need for metrics to more accurately track performance towards the objective of the ADUFA program. AHI stated that to understand true performance towards this objective, they believe there is a need to measure time in agency to gauge time to approval. FDA responded to AHI’s request to publish metrics on total review time in agency and with industry by proposing to add metrics on median time to approval (in days) for administrative NADAs, original NADAs and reactivations, non-manufacturing supplemental NADAs and reactivations, and conditional approvals. A table reporting this information would be modeled on a similar table in the Prescription Drug User Fee Act (PDUFA) annual performance report. AHI did not agree to this proposal because it did not include data on the investigational phase where most of the new animal drug review work is done.  Industry stated FDA’s proposed metrics would be of limited utility, i.e., most NADAs are administrative, and there would rarely be  multi-cycle applications.

AHI stressed that metrics on time to approval was a priority topic for industry because they believe it provides a measure of performance rather than a measure of activity.  FDA proposed enhanced utilization of the lessons learned process to provide feedback on time to approval to sponsors after a new animal drug approval and allow greater discussion on context. FDA expressed its view that feedback to individual sponsors is more beneficial than a metric that provides average information on the length of time from opening an Investigational New Animal Drug (INAD) file to NADA approval.  An agreement was not reached. 

The parties discussed additional metrics. 

AHI requested greater transparency on FTEs and the time spent by review team on protocol (E Submission) and technical section (P submission) reviews.  AHI explained this information was requested to understand bandwidth and resource capacity. 

While discussion on metrics continues, AHI and FDA mutually agreed to include an additional metric on the number of filed and/or submitted sentinel submissions by FDA review division.  CVM reiterated that progress toward meeting performance goals for sentinel submissions would continue to be reported at the program level. 

Meetings 

FDA and AHI discussed an FDA proposal for a revision to performance goals associated with sponsor meetings – pre submission conferences (PSC) and Other ONADE (OO) meetings. FDA proposed that meeting performance goals be limited to virtual, and not in-person, meetings.  FDA proposed having the sentinel submission associated with scheduling the meeting apply to the virtual meetings only.  AHI proposed that written feedback be provided faster (i.e., 50 days) following submission of the meeting request for both PSC and OO meetings and to provide the memorandum of conference (MOC) by 90 days after meeting request submission.

Mutual Recognition Agreement (MRA) 

FDA elaborated that mutual recognition could be used support a risk-based decision as to whether a PAI would be required to support a new animal drug approval but would not be a substitute.

Follow up on Program Full-Time Employees (FTEs)

AHI asked FDA to justify how funding under ADUFA II, III and IV were utilized.  Because ADUFA fees are primarily used to fund personnel, AHI asked FDA to explain the breakdown of current personnel, change in personnel over time and breakdown of activity of the personnel.  AHI also requested the total number of process FTEs funded by user fees and the total number of process FTEs funded by budget authority (BA).  In response to the requests, FDA provided totals for the following within FDA’s Office of New Animal Drug Evaluation (ONADE): FTEs, ADUFA process FTEs, and ADUFA User Fee FTEs. FDA clarified that the “process” FTEs are funded by both BA and user fees. AHI asked about the percentage of FTEs working on ADUFA-specific activities; the total number of positions for which FDA is actively recruiting, by review division; and the average time a vacant position remains open. In response, FDA discussed generally how hiring and backfill decisions are made. FDA indicated there was not a current need for additional FTEs.  FDA referred AHI to the ADUFA financial reports for a more complete accounting of the program’s finances.

Responding to a question from AHI, FDA explained how the Fees Exceed Costs (Standard Cost per Unit) is calculated and changes every year based on activity time reporting data. FDA committed to providing AHI with additional documentation on how this is calculated annually. 

Other Program Enhancements, including Residue Method Trials, Import Tolerances, and ADAA 

AHI proposed goals letter language for Residue Method reviews. FDA agreed to review the proposed language and provide feedback to AHI. AHI discussed the importance of timely US approvals and explained their belief that allowing desk review acceptance of the validated method to receive a technical section completion would expedite approval.

An interim discussion between FDA and AHI on combination drugs under the Animal Drug Availability Act (ADAA) was postponed and will be rescheduled. 

FDA explained its interpretation that the review of Import Tolerances is not eligible to be funded by user fees; and therefore, this issue should not be included as part of the ADUFA program. An interim discussion between FDA and AHI will be scheduled.  

Raw Data, H Submissions, and CMC

AHI and FDA continued discussion on enhancement topics for raw data, H Submissions and CMC including: 

• a draft guidance for industry (GFI) on raw data submissions in support of applications
• expanding the raw data pilot program to include effectiveness data in addition to target animal safety data. 
• a policy & procedures (P&P) document and a public Q&A webpage that outlines the components of the raw data H submission to support both target animal safety and effectiveness protocols.
• FDA’s proposal to develop a P&P document and a public Q&A webpage outlining the process to participate in FDA’s electronic data capture (EDC) program
• development of a P&P document on H submissions to provide clarity on the information that should be included in an H submission and to document the criteria for when the associated H submission can be submitted prior to submitting a study protocol or a meeting request.
• FDA’s proposal to develop a new P&P document for CMC Reviewers that describes considerations for deciding when to amend, use shortened review time, or incomplete submissions and what to do when GMP status (or pending pre-approval inspection (PAI)) is the only comment remaining; and
• revision to GFI 227 (Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections) to allow for parallel submissions of drug substance and drug product information. 
  • FDA indicated that it is considering the ability to submit sterile process validation information in parallel or to provide feedback using an alternative mechanism. 

FDA’s Financial Responses Presentation

FDA provided their feedback following review of AHI’s financial proposals. With respect to financial planning, FDA supported AHI's proposal to publish a five-year financial plan for the ADUFA V program.  FDA committed to publishing the plan by the end of the second quarter of each fiscal year.

FDA tentatively supported AHI's proposal for an independent third-party assessment, with the caveat that the evaluation must be targeted in scope and funded by an additional one-time cost in ADUFA user fees. AHI’s current thinking is to use carryover dollars for such an assessment, if the parties ultimately reach agreement on its inclusion in ADUFA V. The parties will schedule an interim meeting to continue discussion on the scope of the third-party assessment. 

FDA expressed openness to AHI's proposal to change the sponsor fee to a tiered model. FDA provided a proposal with options for a multi-tier sponsor fee. AHI asked clarifying questions and stated that they would consider the options proposed by FDA.

FDA provided a counter proposal with options for changing the workload adjuster. AHI expressed its view that FDA and AHI are not yet aligned enough to reach agreement, specifically with respect to determining the appropriate base years. FDA proposed focusing on 3- or 5-year averages, while AHI requested to consider the entire life of the ADUFA program asserting that the workload significantly decreased since the beginning of the ADUFA program.  

FDA did not accept AHI’s proposal related to over- and under-collections. Following up on information AHI provided on January 4, 2022, regarding the use of an offset provision by other user fee programs in FDA, FDA clarified that no other programs in FDA have an offset provision.

FDA did not accept AHI’s proposal to add a carryover cap. AHI contended that the carryover cap is the mechanism other user fee programs use to avoid over- and under-collections.

FDA proposed a second ADUFA financial package, including a cost for base funding and the program enhancements that have been tentatively agreed to by FDA and AHI.  AHI voiced concern that justification for the current funding level and any additional fees needed to be provided for increases to be considered.  FDA explained funding proposals were based on internal estimates of the program enhancements and the cost to continue the current programs. AHI repeated their request to understand how FDA made this determination.  

Next Steps  

FDA and AHI team members agreed to action items and next steps. AHI requested the next meeting focus on justifying the ADUFA budget.  FDA and AHI team members agreed to schedule an interim discussion regarding ADAA combinations and import tolerances. 

The meeting adjourned at 2:30 pm.