ADUFA V Negotiations Meeting Minutes
January 11, 2022, 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, for FDA to respond to AHI’s financial questions, and for FDA to present a second financial package.
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
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.
AHI previously provided a presentation on proposed metrics. An interim session was held when AHI and FDA were unable to find agreement on proposed metric enhancements. In this negotiation meeting, FDA provided additional feedback after considering the discussion from the interim session and both parties clarified their positions.
AHI continues to underscore their position of the need for metrics to more accurately track performance towards the principal objective of the ADUFA program: to expedite the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions. To understand true performance towards this objective, AHI stated their position that there is an absolute 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 time to approval 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 time and work are 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 (or time in agency and time with industry) was a priority topic for industry because their position is it provides a measure of performance rather than a measure of simple activity. FDA previously expressed the difficulties in reporting such a metric and as an alternate proposed enhanced utilization of the lessons learned process to provide feedback on time to approval to sponsors after a new animal drug approval which would allow greater discussion with individual sponsors on the review process and information submitted to support the approval. FDA expressed its position that candid 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. AHI continues to underscore their position that current performance goals measure activity, but not progress towards the objective of the program and therefore there needs to be a metric that measures review time in agency.
The parties discussed additional metrics.
AHI requested that CVM publish metrics on the number and percent of sentinel submissions by type per review team that have a favorable outcome. AHI stressed their position that the reporting of reviews during the investigational phase was important. FDA opposed the approach of adding to the annual ADUFA performance report a table showing favorable and unfavorable outcomes for investigational protocol and data submission types. Instead, FDA proposed a third-party assessment which could include an assessment of the cycle times under the investigational stage of new animal drug development to assess program performance and multi-cycle review.
In past ADUFA V negotiations and in the interim session, AHI pressed for 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. FDA declined to provide information on FTE hours stating it was proprietary information. An alternative metric was not proposed.
While discussion on metrics continues, AHI and FDA tentatively 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 not be reported by division, but rather continue to be reported at the program level.
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.
Mutual Recognition Agreement (MRA)
FDA elaborated that mutual recognition could support a PAI 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 sought to understand the total number of process FTEs funded by user fees and the total number of process FTEs funded by budget authority (BA). FDA has previously declined to provide information on FTE time spent in direct review activities. 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. This information was not provided, rather FDA discussed generally how hiring and backfill decisions are made. FDA indicated there have not been challenges in hiring and the agency was adequately staffed with no 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 presented on the importance of timely US approvals and explained that investigating ways to enhance the process by allowing desk review acceptance of the validated method to receive a technical section completion could expedite the review process.
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 enhancements for raw data, H Submissions and CMC, including the publication of Guidance for Industry and policies and procedures documents on raw data submissions and on chemistry, manufacturing, and controls (CMC) reviews and phased data submissions, and expanding the raw data pilot program.
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 and what range of years to use for the base years.
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 to meet the current user fee commitments. AHI repeated their request to understand how FDA made this determination.
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.