MUMS White Paper

Introduction

In 1996, Congress approved the Animal Drug Availability Act (ADAA) to streamline the animal drug approval process with the goal of increasing the number of products available to prevent and treat disease in companion and food animals. The ADAA did not mandate specific changes to improve the availability of drugs for minor animal species or minor uses but it did require the US Food and Drug Administration (FDA) to propose ways this might occur. The shortage of approved drugs causes animal suffering, loss of animal life, and financial loss.

The Minor Use and Minor Species Animal Health Act ("MUMS") is a consensus document based on the proposals put forth by the FDA in response to the congressional mandates in the ADAA. This legislative proposal was developed through the efforts of FDA, veterinarians (including wildlife, zoo and public aquarium DVM's), livestock, poultry, fish, game bird, and rabbit producers, and pet product manufacturers, feed manufacturers and the companies that develop animal drugs.

Minor Species

Minor species are by regulatory definition, any species other than dogs, cats, horses, cattle, swine, chickens and turkeys. Terrestrial minor animals include sheep, goats, game birds, emu, ranched deer, elk, rabbits and cavies (e.g. guinea pigs), earthworms, crickets, frogs, salamanders, snakes, lizards, tortoises, caged birds, free-ranging wildlife and those in zoos and small pet mammals (not dogs and cats). All aquatic animals, including all finfish, aquatic turtles, crustaceans, and mollusks are minor animal species. Minor species include a wide range of animals including those that are kept as household pets, those kept for display and educational purposes in zoos and public aquariums, and those that are raised commercially as food or for recreational fishing. While there is a great variety of minor species, they all share a significant need for pharmaceutical tools to improve their health and welfare.

Minor Uses

A minor use is a use of a drug in a major species for an indication that occurs infrequently or in limited geographical areas.

Significance

Each minor species has significant impact nationally, regionally or locally. For example, in a recent survey, it was shown that 61% of all US households shared their home with a least one species of pet animal.

Nearly 2 million American homeowners own a pet rabbit.

Retail sales of ornamental fish and fish products were estimated at $1.34 billion in 1994 and of this, $463 million went toward the purchase of live fish. About 95% of the ornamental fish produced in the US originate from Florida's tropical fish farms that collectively raise over 800 varieties of fish. Ornamental goldfish and koi producers generate approximately $40 million in farm sales that translate to about $200 million at the retail level. The US baitfish (golden shiners, goldfish and fathead minnows) industry is valued at approximately $60 million. The catfish industry is the largest aquaculture sector in the US (over 50% of all aquaculture production) with production of about 600 million pounds annually. It is estimated that the catfish industry (production and processing) generates over $2 billion with over 6000 jobs. Tilapia farming generates about $20-30 million and the trout industry about $74 million annually (wholesale value). Other aquatic minor animal species raised include striped bass, lobster, shrimp, clams, mussels and oysters.

In the US there are 68,000 sheep producers raising approximately 7.3 million sheep.

The game bird (pheasant, partridge, quail, duck and wild turkey) industry is valued at $81 to $176 million with about 47.6 million birds produced each year.

Although more people visit zoos than all of the major sports events combined, zoos have become more than a mere place of entertainment. The modern zoo assists the cause of species conservation and as such has developed numerous species survival plans designed to help maintain our planets' biological diversity. Maintaining the health of rare, threatened, and endangered animals is the responsibility of the zoo veterinarian; however, the availability of drugs for this class of animal is limited.

Like the zoo veterinarian, the wildlife veterinarian is often limited in their efforts to maintain the health of our wildlife or to provide treatment due to the limited availability of effective drugs.

For each species, various conditions exist that require a drug treatment. Approved pharmaceutical agents are limited or just not available for terrestrial and aquatic minor animal species raised and kept in the US for farming, for education, for sports, for species preservation or as companion animals.

Basic Need for Legislative Relief

Due to the nearly complete absence of drugs to treat each of these minor species, most animals either go untreated or treatment is delayed. Delayed treatment is poor treatment; the result is increased suffering, loss of life and loss of social and economic value. The emotional and economic impact of these losses for individual families and the public can be significant. The sheep industry loses nearly $45 million worth of sheep each year and the catfish industry estimates their losses at $60 million from disease conditions for which therapeutic medicines are unavailable. Internationally, the availability of drugs to treat minor animal species is much greater.

In Japan, their aquaculture industry has over 29 different drugs or combinations of drugs to treat just a few fish species while the US industry, with over 800 different species, have only five approved drugs. This puts US producers at considerable economic disadvantage in minor species food production and exacerbates our seafood trade imbalance. The loss of one individual of an endangered or threatened species due to lack of available approved drugs cannot be measured in dollars.

Minor Use and Minor Species Animal Health Act

The MUMS Act creates several new ways of providing drug approvals for use in minor animal species health management programs. The Act

  1. incorporates the significant proposals made by the FDA's Center for Veterinary Medicine to increase the availability of drugs for minor species or rare diseases and conditions in all animals;
  2. creates incentives for animal drug manufacturers to invest in product development and obtain FDA drug-marketing approvals;
  3. creates a program very similar to the successful Human Orphan Drug Program that has, over the past 20 years, dramatically increased the availability of drugs to treat rare human diseases;
  4. creates incentives and sanctioning programs while maintaining and ensuring protection of the public health.

Each of the groups participating in this effort believes the Act will help alleviate animal suffering, will promote the health of minor animal species while protecting human health and will benefit the public and their companion animals as well as farmers and their livestock.

Anyone with an interest in background information, updates on the legislative process, or the impact of this legislation, should contact:

American Veterinary Medical Association, Headquarters at (847) 925-8070 or Dr. David Scarfe
AVMA Governmental Relations Division at (202) 789-0007 or Dr. Mark Lutschaunig

Background Information