ADUFA V Negotiations Meeting Minutes
August 26, 2022, 9AM – 11AM
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 will satisfy the requirement in section 740A(d)(1)(F) of the FD&C Act. The overall purpose of this meeting was for AHI and FDA to move beyond the impasse to negotiate the last remaining issue regarding transparency to industry before concluding negotiations.

Participants

FDA

Matt Lucia, Center for Veterinary Medicine (CVM)
Roxanne Schweitzer, CVM
Tim Schell, CVM
Julie Bailey, CVM
Chuck Andres, CVM
Steve Fleischer, CVM
Elizabeth Cash, Office of the Chief Counsel (OCC)
Alissa Jijon, OCC
Matthew Lockeed, Office of Legislation

AHI

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
Alan Taylor, Virbac
John Hallberg, Zoetis
Kathy Vannatta, Phibro
Ron Phillips, Animal Health Institute

The meeting began at 9:06 AM. 

Discussion

FDA and AHI agreed that they are aligned on the enhancements tentatively agreed to in previous negotiations. Among the enhancements are additional metrics to be reported in the annual performance report and quarterly on FDA-TRACK, as well as a third-party assessment that is expected to explore additional metrics that might be reported. FDA and AHI tentatively agreed upon inclusion of the following metrics:

• P submissions at Division level,
• an exploratory goal on time in agency / time in industry,
• favorable outcomes for E submissions and P submissions,
• H submissions by Division,
• average review times for protocols and data sets, and
• percentage of pre-approval inspection risk decisions in which data obtained via enacted mutual recognition agreements were used.

AHI noted the work done to conclude the remaining topics. AHI summarized the final proposal under consideration – to include information on full time equivalents (FTEs), as a measure of hours spent on pioneer drug review work, and head count (the number of distinct people by office and review division) as part of the ADUFA V goals. AHI indicated their view that it is critical for this information to be provided to justify investments in the program and to help industry understand where and why additional spending is required. AHI also indicated their view that the lack of this data from FDA has prolonged the current negotiations and will in the future as well if no changes are made. Industry explained their position that existing information does not demonstrate where additional investments (in staff and therefore funding) may be needed or whether time spent is leading to improved outcomes. There are no metrics to show the division of resources, which is a challenge particularly when AHI believes the data suggests a mismatch in workload and performance across review divisions. FDA stated that they do not currently track user fee FTEs at the Division level, only at the Office level, and that the Agency manages to payroll, not FTEs. FDA stated that user fees contribute 32% of the funding for the pioneer animal drug review program with appropriations paying for the other 68%, and no one person’s compensation is 100% funded by ADUFA user fees. FDA expressed that the agency is accountable to all stakeholders for reporting on this program, as demonstrated in the yearly performance and financial reports submitted to Congress and posted to fda.gov.

FDA acknowledged that PDUFA provides for the reporting of more information than ADUFA does at this time but emphasized that PDUFA’s industry has made a significant investment in funding to develop the systems used for reporting that information and FTEs to maintain them. FDA indicated that they are working on similar methodology for ADUFA that is anticipated to allow for access to additional data. AHI expressed interest in future discussions to learn what investment would be needed to achieve what they would consider greater transparency in this goal. FDA stated that the agency negotiates with industry to agree on deliverables and performance goals that deliver a predictable program to all sponsors. It is then FDA’s responsibility to operationalize its program processes to meet these deliverables and performance goals, reported annually to Congress and the public. FDA indicated their belief that they have been transparent throughout the negotiation process, although they acknowledged that the information provided by the agency was not always the exact information that AHI wanted.

FDA also stated that to the extent possible, the Agency prefers alignment across the user fee programs and consistency in the data reported; for example, the Agency tries to ensure the annual financial reports are consistent across the six main user fee programs administered by FDA.

Based on discussion at this meeting, AHI proposed that FDA provide headcount for each Division in ONADE during the industry engagement meeting that FDA and AHI tentatively have agreed to hold during the AHI triannual meeting. FDA tentatively agreed to this reporting and tentatively agreed to provide data on total CVM headcount and CVM process FTEs during this meeting. In addition, FDA tentatively agreed to include language in the third-party assessment goal to explore additional ways to collect and provide data on how user fee resources are used.

Next Steps

FDA will update the tentative agreements based on today’s discussions.  FDA and AHI anticipate that no further negotiation meetings will be necessary to resolve the remaining discussion items, which will be finalized via email and phone calls before FDA and AHI share the package of negotiated recommendations with their respective ratifiers. No new substantive proposals, significant controversies, or differences of opinion were discussed at this meeting.

The meeting adjourned at 11:01 AM.