Modernizing Animal Health Regulation for a More Secure Future
Around the world, animal diseases are becoming more complex, more interconnected, and more consequential. The animal health industry is investing in products to enable earlier and more specific diagnosis and provide needed therapies to treat and prevent disease. Yet the high cost and extended length of time needed to gain approvals and bring innovative products to market prevents development of many animal health therapies.
Against this backdrop, the Animal Drug User Fee Act (ADUFA) reauthorization process offers a critical opportunity to modernize how the United States develops, reviews, and deploys animal health innovations. Speaking at the public meeting that kicked off the ADUFA VI negotiation process last week, I highlighted recent successes and improvements at the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), which has built a strong foundation for animal health regulation by providing greater capacity, consistency, and predictability. But the next phase must go further. Specifically, we need a regulatory framework that is equipped for the speed, complexity, and technological possibilities of modern animal health challenges.
Existing regulatory systems have not always kept pace with animal health innovation, but recent responses to the New World screwworm demonstrate what is possible when urgency, collaboration, and scientific rigor work together. This effort shows how regulatory systems can move efficiently while maintaining high standards for safety and effectiveness. The same spirit of practical problem-solving should guide ADUFA VI.
To that end, AHI is focused on three priorities for ADUFA VI: speed, innovation, and harmonization.
First, speed matters because delayed access to animal health products can have real-world consequences for veterinarians, farmers, ranchers, and pet owners, and disease-response efforts. Improving timeliness and predictability in the review process means taking a holistic view of drug development and identifying where FDA and industry can better align on data needs, review expectations, and scientific standards. Faster access to safe and effective tools strengthens our ability to prevent, manage, and contain disease outbreaks before they escalate.
Second, for America’s animal health leadership to flourish, we must be the most attractive environment in the world for research, development, and launch. Modern regulatory systems should encourage investment in breakthrough tools while ensuring that veterinarians and producers have access to the best available science. A strong innovation ecosystem ultimately improves animal care, protects food systems, and strengthens preparedness against emerging threats.
Third, harmonization is increasingly important in a globalized world. Animal diseases do not respect borders, and neither does scientific development. Aligning with trusted international regulatory standards and leveraging high-quality foreign data and experience can reduce unnecessary duplication and improve efficiency without compromising scientific rigor.
This is an important issue for farmers and ranchers, pet owners and veterinarians. Farmers and ranchers especially need more solutions to the animal disease threats they face. Innovation promises tools to extend and lengthen the quality of life for our treasured companion animals. These stakeholders also spoke at the ADUFA public meeting emphasizing the need for access to additional animal health tools.
ADUFA VI is an essential part of a broader modernization effort that will help our country address current and future animal health challenges. Modernizing animal health regulation is an investment in resilience, preparedness, and long-term food security. Collaboration across government, industry, veterinary medicine, agriculture, and the broader animal health community, can build a modernized system that supports timely access, scientific advancement, and effective disease response for years to come.
