ADUFA V Negotiations Meeting Minutes
October 26, 2021, 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 V 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.
This was the initial meeting. The overall purpose of the meeting was for FDA and AHI to review and agree to ground rules, for each party to give their opening presentations, and for the negotiating teams to engage in an initial discussion of relevant issues.
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
Elizabeth Cash, Office of Chief Counsel (OCC)
Lori Talley, OCC
Matt Lockeed, Office of Legislation
Rachel Cumberbatch, Animal Health Institute (AHI)
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, AHI
Bret Lao, Hogan Lovells (Counsel for AHI)
Ron Phillips, AHI
The meeting began at 10:00 a.m.
FDA and AHI recognized the negotiation leads and introduced the individuals on the negotiating teams.
Reviewing the Ground Rules
FDA and AHI reviewed the ground rules for negotiations. Three areas were discussed:
- The negotiations timeline, including anticipated date of completion. FDA shared the ADUFA V reauthorization timeline to help provide AHI with an understanding of the time frame needed for required clearances and congressional approval. A tentative timeline was set, but the parties agreed to revisit the goal deadline at the end of the calendar year.
- Timeframe during which the ground rules will remain in place.
- External meeting minutes. AHI requested detailed external meeting minutes for archival purposes, both for current stakeholders and for future negotiating teams.
FDA and AHI reviewed the technical aspects of conducting the negotiations in a virtual format. Negotiations are expected to remain virtual at least through the end of the calendar year. AHI expressed interest in holding in-person negotiations when feasible for both parties.
AHI Discussion of Lessons Learned from ADUFA IV Negotiations
Based on the lessons learned from the ADUFA IV negotiations, AHI requested that negotiations focus on program enhancements first before finances are discussed.
AHI Opening Presentation
AHI shared its mission and its perspective on the ADUFA program. AHI included in its presentation excerpts from the FDA Foods and Veterinary Medicine Program Strategic Plan for FY 2016 – FY 2025, which lists increasing regulatory science capacity to effectively evaluate products, improving the effectiveness of the product development process, and improving predictability, consistency, transparency and efficiency of the review process as key program objectives, the FY 2020 ADUFA performance report, and Public Law 110-316 (ADUFA II; 2008), which stated that fees authorized by ADUFA will be dedicated toward expediting the animal drug development process.
AHI shared its assessment of the current ADUFA program. AHI expressed its view that the program is “measuring motion and not progress” and explained its belief that while there is predictability in when CVM will respond, approvals now require additional cycles meaning time to approval is delayed. AHI opined that ADUFA V needs to close the gap between capacity and performance to be sustainable.
AHI stated that the four types of fees have significantly increased over the course of time, with annual fee amounts having risen over 500-800% from ADUFA’s inception in FY 2004 to FY 2022.
AHI stated that based on their assessment of the financial information available, appropriations have kept pace with user fee funds.
Using the publicly available information included in the calculation of the workload adjuster, AHI stated their belief that the workload submitted to CVM is not commensurate with full-time employee (FTE) increases.
AHI stated their belief that the ADUFA program (FY 2004-2021) has not increased NADA approvals.
AHI compared FDA and European Medicines Agency (EMA) approvals of animal drugs. AHI contended that, based on their research of all animal drugs approved by both EMA and FDA since 2004, on average, drugs were approved in Europe twelve months sooner than in the U.S. AHI used publicly available information to support this statement.
AHI’s proposed principles for ADUFA V were as follows:
- Focus only on pre-market approval process
- User Fees are intended as additive, supplemental to appropriations
- AHI partners with stakeholders to support additional appropriations.
- FDA appropriations have almost doubled over the life of the ADUFA program.
- Close the gap between increased costs/capacity and workload/approvals
AHI wants to focus on three areas to close the perceived gap:
Moving forward, AHI believes continued support of the program requires new metrics and program enhancements to allow for transparent and consistent product development while reducing the time and overall cost of approval, and assuring safe, effective, and quality manufactured products that are properly labeled.
FDA asked a few clarifying questions about AHI’s presentation, including a request for AHI to explain their perspective on the core functions to which they would like to see the ADUFA program return. FDA clarified that the workload adjuster uses only certain types of submissions and does not capture all work coming into CVM.
FDA Opening Presentation
FDA provided its perspective on the ADUFA program, noting that industry and FDA agree that user fees help to support FDA’s public health mission.
FDA’s short-term goal is reauthorization, in order to help FDA continue to promote and protect human and animal health by having the capacity to meet performance goals and continuing to invest in program improvements using a lifecycle approach by ensuring a predictable review process through sustained revenue. FDA’s long-term goal is for the ADUFA negotiation to be a model of cooperation between sponsors and the Agency to ensure the safety and effectiveness of new animal drugs.
FDA proposes to focus on the following areas to achieve the reauthorization goals:
- Cost effective program
- Value added proposals
- Mutual recognition of benefits
FDA presented its thoughts on outcome goals for both FDA and industry:
- Success is dependent on significant interaction between both the Agency and sponsors/applicants. Process improvements agreed upon during negotiations, once implemented, should reduce the average total time to decisions for applications/submissions. FDA and applicants share the responsibility for achieving this outcome while maintaining standards for safety and effectiveness.
- Success of this program will require the cooperation of FDA and sponsors/applicants to reduce their respective portions of the total time to decisions.
FDA shared the high-level benefits of the ADUFA program.
- Provide more predictable timelines to evaluate new animal drug submissions
- Facilitate the review of animal drugs to better meet the therapeutic needs of animals
- Facilitate the review of animal drugs used in food animal production to help protect both human and animal health
FDA highlighted the following specific accomplishments of the ADUFA program:
- A list of animal drugs approved during the current authorization and the number of approvals since the beginning of the ADUFA program.
- IT enhancements that have been made during the current authorization, including electronic submissions and electronically linked applications so that updated CMC information needed only to be submitted to one application, and CVM’s system would replicate that information in the other linked applications.
- Stakeholder collaboration and transparency initiatives that FDA has accomplished.
- Chemistry, Manufacturing, and Controls (CMC) enhancements.
- Innovation in new animal drug development.
- International collaboration, including the US-EU (in process) and US-UK Mutual Recognition Agreements (MRAs).
- Meeting emerging public health challenges.
FDA shared a high-level overview of the ADUFA IV revenue to date.
AHI asked clarifying questions about FDA’s presentation. AHI requested clarity on funding of CVM/ONADE activities during lapses in government funding. CVM explained the scope of permissible activities.
FDA and AHI engaged in dialogue following the presentations. FDA inquired about the hurdles for industry. The AHI response focused on the probability of regulatory success and time to approval. Industry shared their perspective that other regulatory Agencies (e.g., EMEA) offer greater probability of regulatory success and faster time to approval. The parties discussed what variables may contribute to this difference.
A brief discussion was held on the scope of the negotiations. FDA indicated that it would like to present a couple of proposals that might be perceived as outside the traditional scope of negotiations but still relate to the approval process. AHI emphasized its view that negotiations should remain focused on pre-approval drug development activities but expressed willingness to at a minimum hear FDA’s proposals.
Establishment of Agenda for Future Negotiations
FDA and Industry discussed action items from this meeting and the possible topics for the next meeting on November 9, 2021.
The meeting adjourned at 1:45 p.m.