An industry-wide call to streamline and modernize the complex regulatory frameworks that currently oversee animal health in the US is gaining traction in veterinary circles. Veterinary oversight is surprisingly out of date despite its crucial importance, and experts claim this gap is limiting their capacity to protect both people and animals.
A remarkably thorough report from the Reagan-Udall Foundation, which was ordered by the FDA’s Center for Veterinary Medicine, is at the center of the conversation. The report outlines a plan for what many consider to be a long-overdue change that could modernize the development, approval, and distribution of animal medications, food ingredients, and biologics.
| Item | Detail |
|---|---|
| Primary Concern | Outdated, fragmented regulations hindering veterinary care |
| Leading Bodies | Reagan-Udall Foundation, FDA CVM, AVMA |
| Core Recommendation | Modernize and unify regulatory pathways for animal health |
| Global Relevance | Aligns with One Health goals across human, animal, and environmental health |
| Notable Challenges | Antimicrobial resistance, inconsistent drug approvals, regulatory delays |
| Urgency Factors | Supply chain disruptions, zoonotic threats, workforce shortages |
| Opportunity Highlighted | Improve veterinary innovation, global competitiveness, and emergency response |
The report suggests a more open, flexible, and responsive system based on the 21st Century Cures Act. It highlights the stark contrast between the relative stagnation on the animal side and the innovation in human healthcare. For instance, animal health is still constrained by strict interpretations of regulatory categories that were created decades ago, whereas advancements in human medicine today enjoy the advantages of expedited pathways and flexible review procedures.
One of the more perplexing examples is the misclassification of some nutritional ingredients as drugs under current regulations. This discourages businesses from investing in the development of animal-specific products in addition to delaying their entry into the market. Consequently, veterinarians have fewer resources available to treat their patients, especially in rapidly expanding fields like precision livestock farming and pet wellness.
In order to allow regulators to evaluate products based on risk and use-case rather than out-of-date definitions, the report urges Congress to intervene and redefine the fundamental terms that serve as the basis for these reviews. More flexibility would be possible with this strategy, which would be especially advantageous for small species and newly developed animal treatments.
It also draws attention to the persistent problem of compounded drugs, which are pharmaceuticals made from bulk ingredients to suit the needs of specific patients. The lax enforcement surrounding unapproved compounded drugs has led to a competitive imbalance, even though it is frequently necessary. Less regulated alternatives undercut businesses that adhere to official FDA pathways, discouraging appropriate research and development.
The FDA has made some progress in this area over the last ten years, including issuing industry guidance. However, enforcement is still uneven, and the Reagan-Udall report calls for significantly better oversight in addition to more easily accessible legal pathways for customized drugs.
The One Health framework, which acknowledges the intricate relationships between environmental, animal, and human health, is a crucial component. There has never been a more pressing need for a coordinated response given the rise in antimicrobial resistance and zoonotic diseases. The study promotes more thorough monitoring of antibiotic use, particularly for companion animals, which have traditionally gotten less attention despite being close to people.
One rural veterinarian I spoke with at a roundtable last fall described how she continues to manually track antibiotic prescriptions using spreadsheets and sticky notes. Others in the room shared her frustration, particularly when she contrasted their shortcomings with the advanced systems found in hospitals for humans a few towns away.
The report goes beyond medications and diagnostics. It examines structural inefficiencies in federal agencies more broadly. Regarding animal products, the FDA, USDA, and EPA frequently have overlapping, occasionally conflicting, jurisdiction. For both businesses and practitioners, this leads to redundant reviews, muddled terminology, and regulatory backlash.
The expert panel suggests creating a permanent interagency working group to address this. Streamlining definitions, coordinating review processes, and making sure that creativity isn’t buried in bureaucratic red tape are the duties assigned to such a group. The report makes the case that by doing this, the United States could considerably speed up the release of essential products, especially in times of medical emergency when time is of the essence.
Veterinary care underutilizes emergency use authorizations, which are frequently used in human health emergencies. The Department of Health and Human Services should streamline the procedure for animal-specific requirements, like new vaccines or imported treatments during outbreaks, according to the report. If put into practice, these suggestions would be especially creative in preparing vets to act quickly in the event of a supply chain disruption or zoonotic spillover.
Workforce capacity is another major issue. Like many agencies, the FDA CVM has trouble hiring experts with extensive industry knowledge, especially when it comes to minor species or rural livestock care. In order to attract talent, particularly in underserved areas, the report suggests utilizing flexible hiring authorities and raising salaries. It also urges the larger veterinary community to support new training and retention pipelines, which would be particularly helpful in filling in gaps across species and geographic divides.
The United States has the chance to improve its domestic veterinary systems and bring them closer to their international counterparts through strategic reforms. A unified, science-based regulatory framework could expedite exports, cut down on approval redundancies, and guarantee that a fragmented compliance environment doesn’t penalize American producers.
Importantly, the suggestions don’t seem like wishful thinking. They are based on concrete, doable recommendations, such as interagency agreements or changes to the statute. However, they need industry cooperation and political will. That alignment will be difficult because stakeholders include everything from nonprofit animal shelters to pharmaceutical manufacturers. However, the way forward is remarkably obvious.
The veterinary industry can no longer afford to function in silos at the time the Reagan-Udall report is released. Global competition, rising public interest in pet wellness, and the emergence of diseases driven by climate change are all forces that call for a coordinated response. In addition to requesting improved regulations, the veterinary sector is providing a model for their creation.
From this perspective, the demand for standardized, future-ready frameworks is more than just a professional issue. It is a national duty that affects public health, food security, and the intricate, frequently unseen systems that underpin daily existence.
