FDA announces ongoing progress in its Animal and Veterinary Innovation Agenda

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The FDA recently shared progress on its Animal and Veterinary Innovation Agenda (AVIA), including a pilot program to address unmet animal needs, optimizing and updating regulatory processes, and entering into a contract with a 3rd party to assess the FDA’s animal drug approval process.¹ According to the FDA, the AVIA aims to ensure the strongest product development pipelines that provide the necessary products to support veterinarians, animal owners, agricultural producers, the food system, and public health initiatives.²

Released last fall, the AVIA contains 4 objectives with supporting actions for how the FDA can foster and drive innovation to better protect human and animal health. These objective are as follows²:

• Support technologies and products that address high-priority needs
• Align regulatory pathways to the modern landscape
• Enhance our One Health workforce for the future of innovation
• Identify and address gaps specific to new technologies and emerging health threats

As part of the AVIA, the FDA began a pilot project for the ‘Accelerating the Development of Veterinary and Animal Needs’ (ADVANce) program. This project will help tackle unmet needs in animal health, such as diseases lacking FDA-approved treatments. ADVANce’s priority is to pinpoint barriers in developing products for preventing or treating histomoniasis. This disease, otherwise known as blackhead disease, is a threat to turkeys across the country, and often results in their death.¹

The FDA has also included additional features to its Veterinary Innovation Program (VIP), a program that aims to facilitate progress in developing innovating animal products.³ As part of its expansion, the FDA implemented VIP Plus, which provides tools and support to those developing intentional genomic alterations in animals and animal cells, tissues, and cell-or tissue-based products.^1,3

The agency also made revisions to its guidance documents ‘Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach’ and ‘Heritable Intentional Genomic Alterations in Animals: The Approval Process,’ to provide clarification to the FDA’s approach to regulating genomic alterations in animals.

“The updated guidance documents underscore the agency’s commitment to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictability and efficiency,” Tristan Colonius, DVM, MPA, DACVPM, chief veterinary officer and deputy director for science policy at the FDA’s Center for Veterinary Medicine, wrote in a report.¹

According to Colonius, the organization has been encouraging sponsors of novel products for addition to animals’ food or drinking water to contact the FDA during early product development process to allow for collaboration. The agency also went through with its plan to withdraw the Program Policy Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims.

Additionally, the FDA has contracted Eagle Hill Consulting, an independent management consulting film, to carry out a thorough evaluation of its animal drug approval procedures, according to a news report.¹ “A healthy organization engages in continual self-evaluation and improvement, and this assessment is one part of that ongoing effort,” wrote Colonius in the report.¹

The assessment with Eagle Hill Consulting will involve consultation with agency and industry representatives. The FDA plans to hold a public workshop to share the findings of the final assessment report. This report, along with the public meeting, is expected to be completed by December 31, 2025.¹

References

1. Colonius T. Stepping stones and next steps: The first year of the Animal & Veterinary Innovation agenda. U.S. Food and Drug Administration. August 22, 2024. Accessed September 4, 2024. https://www.fda.gov/animal-veterinary/news-events/stepping-stones-and-next-steps-first-year-animal-veterinary-innovation-agenda?utm_medium=email&utm_source=govdelivery 
2. Animal and Veterinary Innovation Agenda. U.S. Food and Drug Administration. Accessed September 4, 2024. https://www.fda.gov/animal-veterinary/products/animal-and-veterinary-innovation-agenda
3. VIP: Veterinary Innovation Program. U.S. Food and Drug Administration. Accessed September 4, 2024. https://www.fda.gov/animal-veterinary/biotechnology-products-cvm-animals-and-animal-food/vip-veterinary-innovation-program