There is a simple economic problem hidden inside veterinary medicine: developing a new medicine is expensive, and companies need some reasonable expectation that enough patients will need it to justify that cost. But the biological need does not disappear just because the commercial market is small.
That tension sits behind a new three-year strategy from the U.S. Food and Drug Administration. In June 2026, the FDA’s Center for Veterinary Medicine published its Minor Use and Minor Species Blueprint for Success: 2026–2028, setting out plans to modernise and expand the programme intended to encourage development of medicines for underserved animal populations. The terminology sounds niche. The problem is not. It includes medicines for sheep, goats, fish, honey bees, wildlife and other species that fall outside the seven species FDA classifies as “major,” and it can also include treatments for uncommon diseases affecting major species such as cattle, pigs, chickens, turkeys, horses, dogs and cats.
FDA connects better access to these medicines with animal welfare, food security, agricultural sustainability, conservation and the ability of veterinarians to respond to emerging health threats. Behind all of those objectives lies a broader One Health security question: what happens when the economic value of developing a medicine to its manufacturer is smaller than the biological value of having that medicine available to society? That is not simply a veterinary drug-development problem. It is a problem in the economics of preparedness — and, as we set out below, a natural lead-in to the question at the heart of our forthcoming Monthly Review No.002, The Economics of Prevention.
What does “minor” actually mean?
The language can be misleading. Under the U.S. regulatory system, seven animal species are classified as major species: horses, dogs, cats, cattle, pigs, turkeys and chickens. All other animal species are minor species. That means “minor” includes animals of substantial agricultural, ecological and economic importance — sheep, goats, fish, honey bees, bison, gamebirds and many aquaculture species, alongside zoo animals, wildlife and less common companion animals, are all minor species in this regulatory sense.
A minor use, meanwhile, can occur within a major species: a disease affecting cattle, pigs or chickens can qualify if it occurs infrequently, affects a sufficiently small number of animals, or is geographically limited. The distinction is economic and regulatory. It is not a judgement about biological importance, and that difference matters.
The orphan-drug problem of veterinary medicine
The basic market failure is familiar from human rare-disease medicine. Drug development requires investment in discovery, formulation, toxicology, manufacturing, clinical studies and regulatory approval. A company contemplating that investment estimates the potential market. For a medicine used by millions of animals, the economics may be attractive; for a disease affecting a relatively small population, the calculation changes, because development costs do not necessarily fall proportionately with the number of animals that will ultimately receive the medicine. The market does.
FDA recognised this problem formally when Congress passed the Minor Use and Minor Species Animal Health Act in 2004. The resulting MUMS programme performs a role broadly analogous to orphan-drug policy in human medicine: change the economics sufficiently that medicines which would otherwise be commercially unattractive have a better chance of being developed. More than twenty years later, however, the problem has not disappeared.
The independent evidence is important
In March 2026, the U.S. Government Accountability Office examined unmet animal-health needs and the effectiveness of federal incentives intended to encourage veterinary drug development, in a report titled Animal Drugs: Strengthening Federal Incentives Could Help Address Unmet Animal Health Needs. Its conclusion was unusually clear: high development costs and limited markets continue to contribute to shortages of FDA-approved medicines for minor species and uncommon diseases. GAO found that existing FDA incentives had helped, but were not sufficient to overcome the low profitability of some products.
That matters because it changes how the issue should be understood. This is not simply a case of pharmaceutical companies overlooking worthwhile products. There are circumstances in which the market is behaving exactly as economic incentives tell it to behave. The social problem is that the resulting outcome may still be undesirable.
How government tries to change the equation
The MUMS framework already contains several mechanisms intended to alter that commercial calculation. A sponsor can seek MUMS designation for an eligible drug and intended use — designation does not mean FDA has approved the medicine, but it provides access to development incentives, and if the designated drug subsequently receives approval or conditional approval, the sponsor can receive seven years of exclusive marketing rights for that particular drug, dosage form and intended use. A longer protected market can increase the potential return from developing a product for a small population.
Designation can also make sponsors or their research partners eligible for federal grants supporting qualifying development studies. For the FY2027 programme, FDA states that awards can reach $250,000 per year, with up to two years available for routine safety, effectiveness and some manufacturing studies, and potentially three years for toxicology work. These grants do something different from exclusivity: instead of increasing future revenue, they reduce development cost today.
Eligible MUMS drugs can also use a conditional approval pathway. A conditionally approved drug must meet applicable safety and manufacturing requirements and demonstrate a reasonable expectation of effectiveness, and can then become legally available while the sponsor completes the effectiveness evidence required for full approval — shortening the period between development and legitimate market access while allowing the developer to begin recovering some of its investment. Together these mechanisms attempt to reduce development cost, improve potential return, and accelerate access all at once. Yet GAO’s 2026 findings suggest there remain cases where even that is not enough, which is why FDA is now proposing further modernisation.
The new Blueprint
FDA’s MUMS Blueprint for Success: 2026–2028 sets out a three-year programme intended to create a stronger pipeline of veterinary medicines for underserved species and conditions. The strategy includes improving regulatory processes, strengthening engagement with developers and other stakeholders, increasing staffing and operational capacity within FDA’s specialist MUMS office, and exploring additional mechanisms that may require action by Congress.
The broader objectives are striking. FDA explicitly connects improved drug availability with domestic food security, the economic sustainability of minor-species agriculture, animal health and welfare, wildlife and endangered-species conservation, and preparedness for emerging animal-health challenges. That is much closer to a resilience strategy than a narrow pharmaceutical-policy programme.
Blackhead disease demonstrates the problem
One particularly useful example is blackhead disease, or histomoniasis, in turkeys. The disease is caused by the protozoan parasite Histomonas meleagridis and can cause severe disease and mortality in affected flocks, yet FDA identifies blackhead as an important unmet therapeutic need. This creates the uncomfortable situation in which a commercially significant livestock species can face a serious disease without an FDA-approved treatment capable of filling the therapeutic gap. The problem is not that nobody recognises the disease; the problem is converting recognised need into a commercially and scientifically viable development programme.
FDA has therefore made blackhead one of the early targets of its wider veterinary innovation work. Through an Animal and Veterinary Innovation Center at the University of Arkansas, researchers are investigating H. meleagridis, including its biology and the screening of potential inhibitors. The intervention is revealing: public infrastructure is effectively being used to reduce part of the scientific uncertainty that the commercial market has struggled to justify addressing alone.
A small market can create a large vulnerability
This is where the issue becomes particularly relevant to One Health security. Commercial market size and systemic importance are not the same thing. Consider honey bees: from a pharmaceutical-market perspective, they sit within FDA’s minor-species framework, but from an ecological and agricultural perspective, pollinator health intersects with crop production and ecosystem function. Or consider aquaculture — an individual fish species may represent a relatively specialised pharmaceutical market, but collectively, aquaculture is a major component of food production. Sheep and goats similarly represent smaller U.S. markets than cattle, pigs or chickens while remaining economically and nutritionally important in many agricultural systems.
A conventional market calculation asks how much medicine can be sold. A resilience calculation asks what capability we lose if nobody develops the medicine. Those are not the same question.
Preparedness has an option value
There is another way to think about this economically. A medicine does not have value only when it is being administered — its availability can itself have value. Suppose a disease occurs rarely: maintaining a treatment for that disease may look inefficient during years in which very little product is required, but if an outbreak occurs, the existence of an authorised treatment can change the response options available to veterinarians and producers.
Economists sometimes describe analogous situations through the concept of option value: society pays something today to preserve the ability to act tomorrow. Insurance works partly on this principle. So do strategic reserves, emergency-response capacity, and preparedness against biological threats generally. The economic case for a veterinary medicine may therefore be larger than its annual sales revenue suggests.
This is the same problem prevention repeatedly encounters
The issue connects directly with a broader difficulty we are examining for the next One Health Security Monthly Review, The Economics of Prevention. Prevention frequently produces benefits that conventional accounting struggles to see. If surveillance identifies an outbreak early, some infections never occur. If vaccination prevents disease, the hospitalisation or production loss never appears. If farm biosecurity prevents pathogen introduction, there is no outbreak to count. If a therapeutic capability allows a disease to be controlled rapidly, some of the downstream losses become counterfactual. Success appears as an absence.
Veterinary drug preparedness can suffer from the same problem. The annual market for a product may appear small precisely because the event for which it is most valuable is uncommon. That does not necessarily make maintaining the capability economically irrational. It means the economic model needs to capture more than annual product sales.
A Prevention Ledger view
This is exactly the kind of problem we want the experimental OHS Prevention Ledger to make visible. Instead of beginning with how profitable a medicine is, we might map a chain running from public incentive or R&D investment, through therapeutic development capability, to an approved or conditionally approved treatment, to veterinary response capability, to reduced disease duration, mortality or spread, to potential animal, production and economic losses avoided.
That does not automatically prove that every veterinary medicine deserves public subsidy, nor should it — some interventions will still fail a reasonable cost-benefit test. The important point is that the assessment should include the value of the capability created, rather than looking only at the commercial market available to the manufacturer.
The counterfactual must remain honest
This kind of analysis also creates a danger. It is easy to claim enormous benefits from prevention by constructing an enormous hypothetical disaster — “a $10 million investment prevented a $1 billion outbreak,” for example. Perhaps. But unless there is strong evidence for the probability and scale of that outbreak, the claim can become little more than arithmetic attached to speculation. A credible economics-of-prevention framework needs to distinguish clearly between measured outcomes, modelled outcomes, plausible counterfactuals, and highly uncertain scenarios.
The same discipline should apply to veterinary drug preparedness. The existence of a treatment does not mean an outbreak would otherwise have become catastrophic, but it may change mortality, duration, treatment options, production losses or the range of control measures available. Those effects can be estimated. The uncertainty around them should be visible too.
Antimicrobial stewardship adds another dimension
Therapeutic gaps can also have consequences beyond the untreated disease itself. Where appropriately authorised treatments are unavailable, veterinarians can face more constrained therapeutic choices — depending on species, indication and legal framework, this may increase reliance on alternative drugs, extra-label use where legally permissible, or management interventions that are less targeted than a purpose-developed treatment. That matters particularly in the context of antimicrobial resistance: One Health policy increasingly asks veterinarians to use antimicrobial medicines carefully and selectively, and that objective becomes harder when the therapeutic toolbox is narrow. Investment in appropriate veterinary medicines can therefore contribute not only to treatment capability but also to better antimicrobial stewardship. Again, the value extends beyond units of product sold.
Innovation could change the economics
There is also a technological question. Some of the economics that made minor-market medicines unattractive historically may not remain fixed. Platform technologies could reduce development costs, computational screening can reduce candidate space, shared research infrastructure can lower experimental barriers, improved diagnostics can identify eligible populations more accurately, new manufacturing technologies may make smaller production runs more viable, and reusable regulatory knowledge may reduce uncertainty around subsequent products. None of these automatically solves the MUMS problem, but if the fixed cost of developing a medicine falls, the market size required to justify development falls with it — which makes innovation policy part of preparedness policy.
There is a global dimension
The FDA Blueprint is an American policy initiative, but the underlying problem is global. A species considered commercially minor in one country may be central to food security somewhere else. Goats provide livelihoods and nutrition in agricultural systems across Africa and Asia. Sheep remain economically important across Europe, Oceania and parts of the Middle East. Aquaculture is fundamental to global aquatic-food production. Diseases affecting those animals do not become less important because the U.S. pharmaceutical market for a particular treatment is small.
This creates an interesting international-policy question: who pays for medicines whose biological benefits cross markets but whose commercial value is fragmented between them? That problem will become increasingly important as climate change alters disease distributions, livestock systems evolve and animal populations encounter new pathogen pressures.
The market is not wrong. It is incomplete.
It is tempting to frame this as a conflict between pharmaceutical companies and public interest. That is too simple. A company declining to invest millions of dollars in a product with little prospect of recovering those costs may be making a perfectly rational decision. FDA’s MUMS programme exists precisely because policymakers recognise that rational private decisions can collectively produce an undesirable public outcome. The role of policy is therefore not necessarily to fight the market. It is to change the incentives where the market does not capture the full value of the capability society needs. Grants reduce cost. Exclusivity increases potential return. Conditional approval changes development timing. Public research reduces scientific uncertainty. Regulatory support reduces friction. Each intervention attempts to close a different part of the same economic gap.
Drug development follows markets. Biological risk does not.
That may be the most important lesson from FDA’s new Blueprint. A pathogen does not know whether its host species represents a commercially attractive pharmaceutical market. Disease does not respect sales forecasts. Animal welfare does not become less important because the affected population is small. And the systemic importance of an animal population cannot always be measured by the potential revenue from treating it.
The FDA’s 2026–2028 Blueprint is therefore worth watching for reasons extending beyond veterinary regulation. It represents an attempt to answer one of the hardest questions in biological preparedness: how do we create and maintain capabilities that society may need when ordinary market incentives are not sufficient to create them? There will not be one answer. Sometimes the right intervention will be a grant, sometimes regulatory flexibility, sometimes public research, sometimes market exclusivity, sometimes international collaboration — and sometimes the honest conclusion will be that the expected benefit does not justify the investment. But the calculation needs to begin with the right question. Not simply how big the market is, but what biological capability we need, and what happens if nobody has an economic reason to build it.
Questions & Answers
What does MUMS mean?
MUMS stands for Minor Use and Minor Species. The FDA programme is intended to encourage development of medicines for minor animal species and for uncommon uses in major animal species.
Which animals does FDA consider major species?
FDA identifies seven major species: horses, dogs, cats, cattle, pigs, turkeys and chickens. All other animal species are considered minor species for this regulatory purpose.
So are sheep and goats really “minor species”?
Yes, under FDA’s regulatory definition. Fish, honey bees, bison and many other agriculturally important animals are also minor species. “Minor” refers to the regulatory category and market context; it does not mean the species is biologically or economically unimportant.
What is a minor use?
A minor use involves treating a disease or condition in a major species when it occurs infrequently, affects a relatively small number of animals annually, or occurs within a limited geographic area and affects relatively few animals.
What has the GAO said about this problem?
A March 2026 GAO report (GAO-26-107896) concluded that high development costs and limited markets continue to contribute to shortages of FDA-approved medicines for minor species and uncommon diseases, and that existing FDA incentives have helped but have not always been sufficient to overcome low expected profitability.
How does this connect to the Economics of Prevention?
It is a case study in the same underlying problem: prevention and preparedness capability often produces value that conventional market accounting cannot see, because the benefit shows up as an absence — a disease that never spreads, an outbreak that never escalates — rather than as revenue.
References
- U.S. Food and Drug Administration (2026). FDA Releases Blueprint to Expand Animal Drug Development for Minor Uses and Minor Species. 30 June 2026.
- U.S. Food and Drug Administration (2026). Minor Use and Minor Species (MUMS) Blueprint for Success: 2026–2028.
- U.S. Government Accountability Office (2026). Animal Drugs: Strengthening Federal Incentives Could Help Address Unmet Animal Health Needs. GAO-26-107896, 3 March 2026.
- U.S. Food and Drug Administration (2026). FDA Opens First FY2027 Grant Funding Application Period for Animal Drugs for Minor Uses and Minor Species.
- U.S. Food and Drug Administration. Blackhead Disease in Poultry.
- University of Arkansas System Division of Agriculture (2024). Histomonosis, a Deadly Turkey Disease, Researched With New $3.2 Million FDA Grant.
- One Health Security. Help Us Build the OHS Prevention Ledger.
Key Takeaways
- The FDA published its MUMS Blueprint for Success: 2026-2028 on 30 June 2026 to expand access to medicines for minor species and uncommon diseases affecting major species.
- FDA's regulatory definition of "minor species" includes agriculturally and ecologically significant animals such as sheep, goats, fish and honey bees — only horses, dogs, cats, cattle, pigs, turkeys and chickens count as "major".
- A March 2026 U.S. Government Accountability Office report (GAO-26-107896) found that high development costs and limited markets continue to create unmet animal-health needs, and that existing incentives have not always been sufficient to overcome low expected profitability.
- Current MUMS mechanisms include designation, development grants, conditional approval and seven years of exclusive marketing rights for qualifying products following approval.
- FDA's FY2027 MUMS grants can provide up to $250,000 per year, for up to two years for routine safety and effectiveness studies or up to three years for toxicology work.
- Blackhead disease in turkeys illustrates the problem: a commercially significant livestock disease with no FDA-approved treatment, now the subject of publicly funded research.
- Commercial market size is not the same as One Health importance, food-security value, or preparedness value — which is exactly the problem the Economics of Prevention needs to solve.