Veterinary industry panel calls for transforming animal health for 21st century

A panel of animal health industry experts is calling for transforming and modernizing regulations governing animal health and nutrition. The recommendations range from enhancing new animal drug and food ingredient reviews to improved communication among regulatory bodies.

The Reagan-Udall Foundation for the Food and Drug Administration (FDA) in June released “Transforming Animal Health in the U.S. for the 21st Century,” identifying ways to modernize federal oversight of animal drugs, food, and biologics.

The foundation, at the behest of the FDA Center for Veterinary Medicine (FDA CVM) convened a panel of experts to conduct a strengths, weaknesses, opportunities, and threats analysis of challenges and unmet needs in the veterinary profession, and animal health, animal feed, and food-producing animal industries. The FDA CVM may use the recommendations in the report to help advance its Animal and Veterinary Innovation Agenda.

“Many of the recommendations in this report are rooted in the economic reality that outdated laws and regulations are constraining the FDA, other regulators, and U.S. industry, particularly in the food-producing and companion animal sectors,” the expert panel wrote in the foreword. “These outdated laws and regulations result in cost and time requirements that may lead global companies to abandon product development or choose to seek product approval in foreign countries rather than the U.S., which limits options for U.S.-based veterinarians.”

Report recommendations

The eight panelists—representing academia, professional associations, and industry—pointed to the 21st Century Cures Act (Cures Act) as a potential model for reform.

The bipartisan Cures Act, signed into law in 2016, was “designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently,” according to the FDA.

Writing that the Cures Act “dramatically” improved human medicine innovation by modernizing regulations and enhancing the expertise of regulatory staff, the report urges a similar transformation of the animal health regulatory process.

Specifically, the panel’s report makes recommendations in the following nine areas:

• New authorities: The report says the current regulatory framework for animal health and food products under the FDA has resulted in a rigid interpretation that is stifling innovation and hindering the availability of new products in the U.S. The current definition of an animal drug encompasses characteristics of certain animal food ingredients, forcing the FDA to classify some ingredients as new animal drugs, while other countries have regulatory authorities that allow greater flexibility in categorizing products as food ingredients. The report recommends that Congress modernize the regulatory pathways for animal health products and provide the FDA with more flexibility to interpret the definitions of a drug and food.
• FDA CVM product oversight and review process: The report states that the drug review process for new animal drugs has been described as “out-of-date, onerous, very slow, unpredictable, overly risk-averse, and expensive.” It recommends the FDA and Congress pursue regulatory and statutory changes that allow streamlining data requirements, such as considering a new animal drug review process with a structured risk-benefit assessment framework. The report also recommends that the FDA expedite ongoing efforts to clarify the most appropriate review pathways for various types of ingredients and streamline processes, where possible, to minimize delays in introducing new food ingredients.
• Minor uses and minor species: The report suggests that the FDA consider restructuring the Office of Minor Use and Minor Species (OMUMS) to ensure that the drug review and approval process for minor species falls under its jurisdiction. Adding to that, to address the unique challenges of developing drugs for minor species, OMUMS should take the lead in all product approvals for minor species. “Additionally, greater labeling flexibility is essential to alleviate regulatory burdens and prevent the need for entirely new drug approvals for minor modifications,” according to the report.
• One Health: The One Health approach, which considers all sectors where antimicrobials are used—human, animal, and environmental domains—was described as essential for understanding whether and how antibiotic use contributes to resistance. The report recommends collecting and analyzing antibiotic use data across all animal sectors, acknowledging species-specific needs. Specifically, the report states, “While federal initiatives have focused on livestock, there’s a critical need to expand efforts to companion animals due to their close proximity to humans. Enhanced education for veterinarians and pet owners, along with tools like digital dashboards to track prescribing, can promote more judicious antibiotic use.”
• Global competition and trade impacts: To allow domestic food animal producers to better compete globally, as well as streamline approvals and promote innovation while maintaining safety, the report recommends a harmonized regulatory approach, including reciprocity agreements and mutual recognition of foreign regulatory outcomes. The report proposes starting with drugs for minor species. Further, the report suggests that, to improve the availability of products, industry and regulators collaborate to conduct risk assessments of supply chains for feed ingredients and pharmaceutical manufacturing moving forward. It says the current disparity in regulations—in which imported animal products treated with foreign-approved drugs have fewer hurdles with respect to residue limits and lower costs than U.S. domestic products—creates an unfair competitive landscape for U.S. producers.
• Emergency preparedness and emergency use authorization: The report urges the Department of Health and Human Services to streamline, clarify, and expedite the application of Emergency Use Authorization and Public Health Emergency declaration processes for animal needs. This clarification could include establishing tiered emergency use levels to address immediate, upcoming, and temporary needs, such as drug shortages. In that vein, the report recommends that the FDA explore its enforcement discretion in allowing veterinarians access to drugs, vaccines, and diagnostics that are already approved in other countries to address emerging diseases and other threats in the U.S. The report also states that “a credible, centralized, science-driven coordinator is vital to streamline crisis response among federal, state, and local agencies.”
• Communication and collaboration across key agencies and other stakeholders: The report points out that the U.S. animal health ecosystem is complex because of overlapping and unclear jurisdictions among federal and state regulatory agencies, such as the FDA, U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). To improve clarity, the report recommends that the FDA, USDA, and EPA establish a standing interagency working group to address discrepancies in terminology and processes. With respect to other stakeholders, the report states, “Broadening the scope of regular communication beyond drug sponsors would enable an active dialogue with animal sectors and veterinarians, keeping the FDA up to date with both the immediate needs and forward-looking concerns of the various animal sectors and identifying where gaps in therapy affect the health and well-being of animals.”
• Enforcement gaps and resulting market disincentives: Guidance for Industry #256 (GFI #256), “Compounding Animal Drugs from Bulk Drug Substances,” establishes the parameters within which veterinarians or pharmacists may compound drugs from bulk drug substances. The report recognizes that widespread availability and minimal enforcement against unapproved or illegally compounded drugs disincentivizes companies from pursuing proper drug approvals, creating unfair market competition and hindering innovation. Inconsistent state and federal compounding regulations further complicate matters. The report recommends that the FDA identify pathways to ensure the availability of safe and efficacious FDA-reviewed products for animal sectors that predominately or solely rely on compounded products. The report also recommends that the FDA enforce its stated priorities for compounded drugs, and update and clarify its enforcement priorities for unapproved drugs.
• Workforce considerations: The report recognizes that the FDA CVM is facing an expertise gap in reviewing drug submissions, particularly for minor animal species, as staff may lack familiarity with specific sectors. The broader animal health ecosystem is also dealing with workforce gaps because of various factors, with fewer people serving major and minor food-producing species or working in rural areas because of lower salaries, poor work-life balance, or lack of community support. The report recommends that the FDA use “the agile hiring authorities and salary flexibility” of the Cures Act to increase efficiency and decrease timelines from application to hire to attract highly qualified professionals. It also recommends that the FDA join other animal health stakeholders in efforts to improve recruitment, training, and retention.

“The expert panel recommends efforts to augment the capacity, staffing, and expertise at CVM,” Dr. Lisa Tell, professor of veterinary medicine at the University of California-Davis and panel chair, told AVMA News. “Ultimately, such changes could result in novel approaches in reviewing animal drug and food product submissions that could ultimately have transformative impacts on the animal health industry.”

Stakeholder communication

One particular area of concern the 66-page report highlights is a perceived lack of ongoing communication between the FDA and the industry, especially regarding product development priorities.

The report states, “At present, product development and stakeholder discussions are disproportionately (and somewhat logically) focused on regulated products applicable to major species, which are seen as more economically viable in the U.S., rather than addressing the needs of veterinarians for the enhancement of animal health and welfare. As a result, certain species are being overlooked because of limited return on investment.”

The report also details specific recommendations for the FDA, such as providing clear thresholds for achieving protocol concurrence, well-defined endpoints required for efficacy and safety evaluations, and reducing data burden requirements by more consistently allowing the submission of aggregate data.

“The U.S. review process for animal drugs, including cell and gene therapies, is perceived as lengthy and unpredictable, which results in significant economic consequences and hinders the introduction of innovative products to the U.S. market,” the report states. “This perception may deter some U.S. and global companies because of high costs and regulatory uncertainty.”

Innovation and integrating new technology is the path forward, not only to tackle emerging diseases in real time, but also to address existing animal health issues that affect our food supply, says Katelyn McCullock, AVMA’s chief economist and panelist.

“Veterinarians play a critical role and are at the forefront of many of these issues. Enabling access to the very best therapies, whether its greater access to drugs approved globally, or faster-to-market processes for new drugs, biologics, food additives, or cell therapies, will also have enormous economic implications,” she said.

“The economic impacts of animal disease are tangible, and the U.S. does not have to look far back into history to find a dramatic case that had broad implications. Transforming FDA regulations and improving processes will help lead to lower economic burden and may slow the ripple effect of emerging diseases,” McCullock added.

The panel used various information-gathering methods to inform its report, including roundtable discussions, conversations with FDA CVM staff members, and public comment periods. It sought input from a diverse range of stakeholders, including representatives from federal, state, and local government agencies; nongovernmental organizations, such as the AVMA; pharmaceutical and animal food industries; and users of FDA-regulated products—such as farmers, ranchers, pet owners, zoo operators, and veterinarians.

“The U.S. is due for a holistic overhaul of regulations for animal drugs and animal food,” Dr. Tell said. “To take advantage of significant advances in science, health, and nutrition developed by American innovators, current animal drug regulatory laws desperately need revamping. Pet owners, veterinarians, food animal producers, and farmers would all benefit from Congressional members engaging and focusing on the animal health sector.”

A version of this story appears in the October 2025 print issue of JAVMA