Last week, the FDA released its Foods and Veterinary Medicine (FVM) Program’s Strategic Plan for fiscal years 2016-2025, which outlines goals and objectives for the next 10 years.
Focused on public health, the plan lists specific objectives in four categories, including food safety, nutrition, animal health and organizational excellence.
Within the category of animal health, these objectives, with summarized strategies for each, include.
1. Improve access to safe and effective animal drug products. The plan notes that for approval of drugs intended for use in food-producing animals, manufacturers must demonstrate safety of the drug to animals and also safety of food derived from treated animals. FDA’s FVM program intends to “expeditiously approve safe, effective, quality manufactured, and properly labeled new animal drug products through a science-based approach in a regulatory environment,” according to the plan. Strategies toward achieving this objective include:
· Identify and develop new scientific methods, models, and tools to improve the quality, safety, predictability, and efficiency of new animal drug development.
· Optimize rigorous science-based premarket review to ensure that animal drugs marketed to the public are safe and effective.
· Collaborate with stakeholders, including other regulatory bodies, in the exchange of information to facilitate the efficient evaluation of new animal drug products.
· Facilitate the introduction of innovative products and processes by enhancing the predictability of regulatory evaluation processes of animal drug products.
2. Reduce risks in the manufacturing, production, distribution, and use of FDA-regulated animal health products. The plan notes multiple opportunities for products to be contaminated, diverted, or otherwise adulterated. The FVM Program intends to minimize through oversight of product manufacturing, sale, distribution use of animal health products while implementing new monitoring and enforcement tools. Strategies include:
· Increase coordination with federal, state, local, tribal, and private partners, and enhance monitoring of antimicrobial drug use practices and resistance data to support efforts to foster judicious use of medically important antimicrobials in food-producing animals.
· Increase access, sharing, and use of data from foreign, federal, state, local, and private sources to aid in the assessment of risks related to animal health products.
· Support research to better understand the emergence, persistence, and spread of antimicrobial resistance.
· Enhance risk-informed regulatory frameworks and enforcement tools to reduce the availability of unapproved animal drugs, including unapproved compounded animal drugs.
3. Strengthen detection and surveillance of problems with FDA-regulated animal health products. Noting a need for continuous assessment, the FVM program plans to enhance its efforts to promptly detect, monitor, and learn from problems experienced with FDA-regulated animal health products in order to prevent marketing of unsafe products, including veterinary devices, and to undertake enforcement actions against products associated with adverse events. Strategies include:
· Advance surveillance systems for adverse events for approved animal drugs, unapproved animal drugs, and veterinary devices, to identify safety signals and effectiveness issues of concern.
· Foster development of tools and models to assess the safety of unapproved animal drugs, including compounded animal drugs.
· Collaborate with federal and state agencies to identify and address illegal drug residues in animal-derived food.
· Ensure stakeholder awareness of animal drug quality and integrity issues through effective education.
The FVM program encompasses the Office of Foods and Veterinary Medicine, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine, as well as the related activities under the Office of Global Regulatory Operations and Policy and the Office of Regulatory Affairs.
View the FVM’s 10-year plan online.