Today, the U.S. Food and Drug Administration announced it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase regulatory flexibility, predictability and efficiency.
The Animal and Veterinary Innovation Agenda released today lists four objectives and details the supporting actions by the agency’s Center for Veterinary Medicine (CVM) to foster product development and implement smart, risk-based approaches to regulating modern animal and veterinary products. These actions will further position the agency for continued scientific and technological evolution while helping to bring safe and effective products to the market.
The new agenda applies to products like novel food ingredients that work solely in the animal’s gut to increase nutritional efficiency and production; animal biotechnology products such as animal cell- and tissue-based products (ACTPs) and intentional genomic alterations (IGAs) in animals; cell-cultured animal food ingredients and more. It also aims to encourage the development of products for unmet human and animal needs – particularly to address the lack of targeted therapeutics designed and approved for use in animals.
“Novel technologies brought to the forefront in recent years have the potential to set a new course for the way veterinarians and food producers support human and animal health. The FDA is committed to helping developers bring products that enhance public health, animal health, and food production to market while providing consumers with confidence that they meet the FDA’s high standards,” said FDA Commissioner Robert M. Califf, M.D. “This comprehensive agenda is intended to accelerate smart regulatory pathways and enhance continued public confidence in the FDA’s regulation of these products, while avoiding unnecessary barriers to future industry advancements.”
The FDA is planning to reassess its animal and veterinary product review programs and processes and adjust them, where appropriate, to account for the diversity of products developed using innovative technologies. For example, the agency has been working with Congress on new legislative authority that will introduce new approval pathways for zootechnical animal food substances (novel food ingredients that function in the gut of the animal to affect qualities like feed efficiency, reduced waste output, or reduced pathogens in food products made from the animal).
Modernizing product review procedures will allow the agency to focus on specific questions raised by products developed using new and emerging technologies, bringing clarity and predictability to the review process. Optimizing regulatory processes for smart regulation will ensure that the nation remains confident in the FDA’s longstanding safety evaluation standards and enjoys the benefits of cutting-edge innovation in veterinary medicine and food production.
Recognizing that the health of people, animals and their shared environment is intertwined, a concept known as One Health, this effort also focuses on connecting experts on converging science across the agency. That’s why the agenda commits CVM to continue its work with the agency’s Office of the Chief Scientist – a cross-cutting office that supports the research, science and innovation that underpins the FDA’s regulatory mission – in order to leverage and expand scientific expertise across the agency workforce.
“This exciting time of technological advancement is an opportunity to continue modernizing our approaches in ways that both support and spur innovation,” said CVM Director Tracey Forfa, J.D., M.Div. “These new animal and veterinary products have the potential to make a real difference for both human and animal health, and we have the responsibility to ensure they are safe and effective. This agenda will lead us forward, while also protecting public health and ensuring consumer confidence.”
As part of this agenda, the agency is expanding the popular Veterinary Innovation Program (VIP) to include additional features for developers of ACTPs and IGAs in their interactions with the FDA. The expanded program, VIP Plus, is planned to premiere later this year. It includes new tools that will assist product development and continually improve the efficiency of the FDA’s review process by tailoring data requirements to answer risk questions specific to the product. The agency will also provide advanced computational tools that allow reviewers and developers to analyze complex genomic data.
The agenda also includes plans to continue investment in data modernization, to re-imagine CVM’s vision for its science program, and scan for emerging technologies and scientific developments that may eventually lead to new kinds of animal and veterinary products. Anticipating potential innovations will allow the agency to proactively seek information and adapt its review processes to evaluate the questions raised by new technologies and the products they generate, reducing delays in first-of-kind product reviews.
The FDA intends to publicly track its progress, collaborate with federal, tribal and state partners, and solicit public input on certain elements of this agenda as it continues to implement a scientifically sound, risk-based regulatory approach that propels innovation while protecting public health.
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