Stepping stones and next steps: The first year of the Animal & Veterinary Innovation Agenda
By Tristan Colonius, DVM, MPA, DACVPM, Chief Veterinary Officer & Deputy Director for Science Policy at FDA’s Center for Veterinary Medicine
In September 2023, the FDA unveiled our Animal and Veterinary Innovation Agenda to define our commitment to advancing human and animal health by supporting innovative products and approaches to real-world problems, prioritizing critical needs, streamlining and clarifying regulatory processes, and preparing the agency’s Center for Veterinary Medicine for the future. The Agenda describes some of the actions that we’re taking or proposing to take to help deliver the products that veterinarians, pet owners and animal producers need and to advance public health and sustainable food systems.
Since last fall, we’ve been busy initiating and continuing work on many of the key items described in the Agenda. I’m thrilled to share the progress we’ve made so far – and you can expect to see additional updates as we continue to evolve.
We have initiated a pilot of the “Accelerating the Development of Veterinary and Animal Needs” (ADVANce) program to help address unmet animal needs, like diseases for which there are no FDA-approved treatments. The program’s first undertaking is to identify barriers to development of products that prevent or treat blackhead disease (histomoniasis) – a current and often fatal threat to the nation’s turkeys – and work towards overcoming those barriers. As the program matures, we hope to expand to encompass products that address unmet needs in minor species, such as new treatments for disease threats to fish and small ruminants (such as sheep and goats).
We’ve implemented VIP Plus, an expansion of our popular Veterinary Innovation Program that gives tools and support to developers of novel products like Animal Cell- and Tissue- Based products and Intentional Genomic Alterations in animals. This includes VIP Fast-Step, which abbreviates the review timeline for five types of sponsor submissions, and a recently published webinar demonstrating how to use PrecisionFDA, an advanced computational tool with point-and-click bioinformatics analysis and the ability to securely transmit large datasets like next generation whole genome sequences to FDA as part of a submission package.
We’ve also clarified our approach to regulating genomic alterations in animals by releasing final Guidance for Industry(GFI) #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,” and draft revised GFI #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process,” as well as establishing a memorandum of understanding with the U.S. Department of Agriculture. 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.
Another area where we are making strides is in encouraging sponsors of novel products for addition to the food or drinking water of animals to reach out to us early in the product development process, so that we can work with them to explore the various development and engagement options. To that end, we announced and carried through on our plan to withdraw Policy & Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims, as we work internally and with Congress on a more flexible approach to regulating certain products with specific claims that work solely within an animal’s gut. These products hold great promise to provide beneficial effects that include reducing foodborne pathogens, affecting by-products of digestion (like methane), and improving feed efficiency. We recently issued a letter of enforcement discretion for a new substance for use in animal food, as we continue to pursue a more formalized approach to supporting development of novel products.
We know that regulatory clarity is important for our many and diverse stakeholders. In March, we published a Proposed Rule on Labeling Requirements for Approved or Conditionally Approved New Animal Drugs that would codify regulations for content and format of the labeling for prescription and over-the-counter new animal drugs, as well as new animal drugs for use in animal feeds. Predictable requirements will help animal drug sponsors more efficiently prepare labeling for FDA review. It will also provide a more consistent presentation of information on the safe and effective use of these new animal drugs to help veterinarians, animal owners, and animal producers.
We continue to build for the years ahead by establishing a “Workforce for the Future of Innovation,” to develop a strategic framework to catalog current technological and scientific expertise within the Center for Veterinary Medicine; evaluate and anticipate workforce needs; and recruit, retain, and develop world class scientific and technical talent. The center’s need for expertise will continue to evolve, and the strategy will include a plan for regular re-evaluation.
The final action I’ll mention is that we’ve entered into a contract with Eagle Hill, an independent third party, to conduct a comprehensive assessment of our animal drug approval process. A healthy organization engages in continual self-evaluation and improvement, and this assessment is one part of that ongoing effort. The assessment will include consultation with both agency and industry representatives. FDA will hold a public workshop to present the results of the final assessment report. The assessment report and the public meeting will be completed by December 31, 2025.
We are excited to see all of our efforts coming together and plan to share more with you in the coming months. Most importantly, we are continuing to push forward in our commitment to support the individuals and industries affected by our work, while ensuring that our processes are science driven, risk-based, timely and flexible.