ADUFA V Negotiations Meeting Minutes
February 17, 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 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
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
Mary Hagler, Dechra
Gareth Harris, Merck
Alicia Henk, Ceva
Todd Rhodes, Vetoquinol
Kelly Rosenkrans, Elanco
Kathy Vannatta, Animal Health Institute
Ron Phillips, Animal Health Institute
Fernando Bertazzo, Virbac
Jennifer Harmer, Zoetis
The meeting began at 10:00 a.m.
AHI summarized their position that ADUFA V can help to:
- Enhance accountability for resources in the program by aligning the resources to the actual workload requirements and allocating those resources to the agreed upon priorities
- Reassess metrics and performance to ensure they support the desired outcome
- Enhance transparency in order to increase confidence in the quality and timeliness of reviews
- Lower review/approval times, through increased communication between FDA and sponsors, while maintaining the same gold standard for safety, efficacy, and quality
- Ensure consistency in review standards among review divisions in order to promote predictability for sponsors
AHI shared their position, based on their analysis of data, of a gap between capacity and performance in the animal drug review program. AHI pointed to an increase in fees, revenue, and FTEs alongside the static workload. CVM stated that the Agency also looks at trends in workload. AHI indicated that the trend for each of the available data sets showed flat workload. AHI proposed a strategy targeting three focus areas – performance, enhancements, and financial sustainability – and organized the proposals currently under consideration to articulate the opportunities.
- Proposals included efforts to align user fee funding and workload, enhanced comprehensive metrics, and additional reporting and
- enhanced pre-submission conference goals
- Program Enhancements
- Proposals included fee stability and increased utilization of existing funding; enhanced transparency through publication of Guidance for Industry and policy & procedures documents on raw data submissions and on chemistry, manufacturing, and controls (CMC) reviews and phased data submissions; exploration of a “clock stop” procedure, drug residue method trial process, and the review and approval of ADAA combination drugs
- Financial Sustainability
- Proposals included focus on core program functions, new provisions for the carryover balance, changes to the workload adjuster, and an annual strategic and financial plan
AHI expressed continued support for a third-party assessment of the ADUFA program and explained its position that an assessment is important for each of AHI’s proposed focus areas. AHI emphasized the importance of this assessment to industry’s ability to reach a successful agreement with FDA. AHI shared its view of the assessment as an opportunity to identify areas of future efficiencies.
AHI also discussed the Mutual Recognition Agreements and a legislative correction. Finally, AHI presented their proposal for the cost of the program and provided their calculations to support the cost.
FDA asked clarifying questions about AHI’s presentation.
FDA and AHI discussed the third-party assessment language.
- CVM explained their position that the current evaluation language predominantly focused on CVM activities and expressed interest in the evaluation finding ways industry processes also could lead to efficiencies. AHI supported this concept and proposed that comprehensive metrics such as time in agency and time with sponsor are objective measures to track efficiencies for both CVM and sponsors. AHI further stated that the goal of the assessment is to improve the ADUFA program and provide clarity on the ADUFA program’s performance.
- FDA clarified their suggestion that the evaluation look at all original NADAs, which include those commonly called “administrative NADAs.” FDA agreed to provide the number of full and supplemental NADAs approved from 2019 through 2021 for both food animals and companion animals to ensure there is an adequate number of full NADAs for review.
- AHI recommended that the third-party assessment include evaluation of metrics proposed by individuals with expertise on the animal drug approval and review process. Calculation of base values for the selected metrics was also recommended. AHI emphasized that proposing metrics should increase the likelihood of finding useful data, and they underscored the importance of this process to ensure such data would be available for the ADUFA VI negotiation. FDA indicated their preference that the outcomes and recommendations from the assessment be used to determine which future metrics would be meaningful. AHI did not agree with CVM’s position because it’s AHI’s position that this would delay starting reporting data on time to approval which is important for measuring progress and for preparing for future ADUFA negotiations.
FDA expressed its view and concern that AHI’s counterproposal and proposed program costs appear to be focused on minimizing the program cost at the expense of AHI’s stated goal of program enhancements. AHI explained to FDA that the goal is not necessarily to find the cheapest option, emphasized industry’s need to justify spending, and expressed their position that it was prudent to challenge whether industry’s investment is meeting its intended purpose. AHI restated its position of the gap between workload and the program cost and number of FTEs and explained that this gap is driving industry’s concerns about inefficiencies.
AHI expressed frustration that FDA did not provide a response to some metrics previously requested. FDA explained their view that information and data previously provided had been responsive to those requests and had been presented in a format based on our tracking systems and need to protect proprietary information, even if this format was not the way AHI requested.
FDA stated that their feedback on the third-party assessment had been sent to AHI via email for AHI’s review and that they anticipated AHI would need further time to discuss and respond. FDA then proposed adjourning the meeting.
FDA and AHI reviewed action items and agreed to an email exchange of FDA’s response to AHI’s proposed package and agreed to a possible additional negotiation meeting.
The meeting adjourned at 11:56 am.