A Major Animal Health Concern : The MUMS Bill

by Food and Drug Administration (FDA)

Each October, when the mountain wind begins to carry a hint of winter chill, Lyle Johnston of Rocky Ford, Colo., loads hundreds of wooden boxes containing a special cargo onto flatbed trucks. He wants those trucks and their valuable cargo — 30 million honeybees per truck — to be well down the road and on their way to California before the season's wintry blasts sweep through the Rockies.

The bees are destined to be put to work pollinating the almond fields of California, the source of more than half of the world's almonds. Johnston relies on the almond industry, and the almond industry relies on him and his fellow beekeepers. "Without the bees, the growers get only 300 to 400 pounds of almonds per acre," says Johnston. "With good hives, they get 2,200 to 2,800 pounds per acre."

American farmers rent honeybees to pollinate almonds, apples, melons, and more than a dozen other crops, raising the value of agricultural production by more than $14 billion per year, say entomologists at Cornell University.

Even so, the honeybee industry is dwindling. "It's a tough game right now," says Johnston, a third-generation beekeeper whose grandfather started the business in 1908. Bees are declining in number, largely because of the destructive efficiency of parasitic mites and American foulbrood, a bacterial disease that infects the young bee larvae and is killing off bee colonies across the nation.

Currently, there are no drugs approved by the Food and Drug Administration to treat the blood-sucking Varroa mites or the suffocating tracheal mites, and the one FDA-approved drug to treat American foulbrood is more than 40 years old. "Consequently, the bacteria have become resistant to treatment across large parts of the United States," says Mark Feldlaufer, Ph.D., research leader at the U.S. Department of Agriculture's (USDA) Bee Research Laboratory in Beltsville, Md.

But through the efforts of the Beltsville Bee Research Lab, the FDA, and a national research program called the USDA Minor Use Animal Drug Program, two more antibiotics to treat foulbrood may soon be available, and studies of a drug to treat Varroa mites will soon begin.

Despite their importance to agriculture, bees are considered a "minor species," and drugs to treat them are included in a category known as "minor use" drugs. There are few FDA-approved drugs available for minor use, but efforts to increase their number are being pursued on two fronts: through new legislation and through research partnerships. These partnerships among government agencies, minor species animal interest groups, universities, public hatcheries, and pharmaceutical companies are producing the data needed to support drug approvals.

A minor species is any animal species other than cattle, horses, pigs, chickens, turkeys, dogs, and cats, which are classified as major species.

Minor species include a wide variety of land animals such as sheep, goats, game birds, deer and elk, bison, emus, ostriches, rabbits, free-ranging wildlife, and zoo animals. They also include birds, ferrets, guinea pigs, and reptiles that are kept as pets. Aquatic animals, such as finfish, turtles, crustaceans, and mollusks, also qualify as minor species.

In addition to treating minor species, minor use drugs can also refer to those used in a major species to control a disease that occurs infrequently or in limited geographic areas. An example of a minor use in a major species is a drug to treat the parasitic infection babesiosis in dairy cattle in tropical regions of the United States.

The MUMS Bill

Only one or two drugs a year, on average, are approved for minor species, says Meg Oeller, D.V.M., the FDA's liaison to the USDA Minor Use Animal Drug Program. "It's a small number compared to the need."

But this number could increase with passage of the Minor Use and Minor Species Animal Health Act, known as the MUMS bill. In response to a congressional mandate under the 1996 Animal Drug Availability Act, the FDA proposed legislative and regulatory changes to improve the availability of drugs for minor uses. Building upon these FDA proposals and with the FDA's technical assistance, a coalition of animal health groups drafted the MUMS bill.

The bill would create a program similar to the FDA's human orphan drug program, which has dramatically increased the availability of drugs to treat rare human diseases. The human program encourages drug companies to seek approval of drugs for rare human diseases and conditions by offering companies help with study design and by giving financial incentives, such as tax relief, grants, and extended periods of marketing exclusivity. Similar incentives might encourage animal drug developers.

The MUMS bill also would provide the FDA some options such as conditional approval when reviewing drugs for minor uses. However, "The bill does not circumvent the need for public health and animal safety standards to be met," says Randy MacMillan, Ph.D., chairman of the MUMS Coalition and president of the National Aquaculture Association. "It would still have the mechanisms in place to address antibiotic resistance concerns, public safety concerns, and environmental concerns."

The MUMS bill was introduced in Congress in 2001 and again in 2002. "We continue to work with ... congressional people to get the MUMS bill passed as expeditiously as possible," says MacMillan.

Cooperative Research

Drugs to treat minor species used in agriculture are getting a boost from the Minor Use Animal Drug Program. This USDA program, officially known as National Research Support Project No. 7 (NRSP-7), funds and oversees many of the costly studies required to obtain FDA approval of an animal drug. The results of these studies are made public, and a drug company can then use them without cost to complete the process of applying to the FDA for drug approval. Once approved, the drug can be labeled, marketed, and made available for minor use.

The Minor Use Animal Drug Program works through the cooperation of many organizations. A drug manufacturer agrees to sponsor the drug; state agricultural research services, universities, and veterinary schools conduct studies; animal producers do field testing; and the FDA's Center for Veterinary Medicine (CVM) advises on the requirements needed for drug approval and reviews study results and other data.

Most of the program's efforts involve drugs already approved in a major species. For example, a drug approved for cattle may be studied for its safety and effectiveness in sheep. "With the sponsoring drug company's consent, we can use their toxicology and other data so we don't have to duplicate studies," says Stephen F. Sundlof, D.V.M., Ph.D., director of CVM. "This reduces some of the data requirements and saves a tremendous amount of money."

The program prioritizes and selects projects from requests made by animal producers, veterinarians or researchers. Current funding allows for about 1 in 6 requests to be researched.

About the Author

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