The game bird industry in this country includes the raising of pheasants, quail, partridges, ducks, and wild turkeys. These birds are raised for sale to restaurants, direct to consumers, or for release into hunting areas. The North American Game Bird Association (NAGA) conservatively estimates that 5 to 10 million pheasants, 5 to 12 million Bobwhite quail, 15 to 25 million Coturnix (Japanese) quail, 2 to 4 million Chukar partridges, 100 to 300 thousand Hungarian partridges, 500 thousand to 1 million Mallard ducks, and 100 to 200 thousand wild turkeys are hatched and raised in the U.S. each year.

These birds face all of the challenges faced by other animals raised in groups. They are subject to infectious diseases, parasitism, and production pressures which often necessitate the use of animal drugs. As minor species, they also face the problem that few animal drugs have undergone testing and review to gain FDA approval for them. A minor species is any other than horses, cattle (except veal), swine, dogs, cats, chickens, and turkeys.

In most cases, it is not economically worthwhile for a pharmaceutical company to pursue a minor use approval. The income from the sale of an animal drug for minor species use is limited to such an extent that it rarely can offset the cost of development, production and marketing. In many respects, minor species/minor use drugs are similar to "orphan drugs" in human medicine. Unfortunately, at the present time, unlike orphan drugs for human use, there is no statute that provides economic incentives for pharmaceutical sponsors to pursue animal drug approvals for minor species. This is an area worthy of further exploration.

The limited number of drugs approved for use in minor species places producers such as the game bird growers in a predicament. The producers are prohibited by law from treating their own animals with drugs that are not specifically approved for such a use. Under a policy of regulatory discretion, veterinarians are permitted to use animal drugs in an extra-label manner, including for minor species. The FDA policy on the extra-label use of animal drugs in food-producing animals defines the limits of regulatory discretion to exclude the production of a medicated feed containing an animal drug that was not specifically approved for that use.

Recently, the passage of the Animal Medicinal Drug Use Clarification Act (AMDUCA) essentially legalized FDA's regulatory discretion policy. AMDUCA created a legal means for minor species producers to gain access to drugs for use in their animals through a veterinarian. However, the provisions of the act did not completely address the needs of the minor species producers. Despite the value of using the services of a veterinarian, the economic value of many minor species animals is such that the producers cannot always justify the extra expense to treat their animals. Further, the husbandry practices for many minor species, including game birds, makes medication in the feed the most practical way to achieve appropriate dosing. For example, catching birds for multiple injections or oral dosing of medication is labor intensive and dangerously stressful for the birds. Game birds raised in large outdoor pens will preferentially drink rain water over medicated water making this method of drug administration unreliable.

The North American Game Bird Association is taking the initiative on behalf of its members to address this dilemma. The game bird producers want to work within the law, and protect the safety of their customers who consume game birds. They also want drugs available for use in their animals to be safe and effective. They recognize that the best solution is to get drugs approved specifically for their birds. Toward this end, the organization has followed the model of the aquaculture industry and established a committee to identify and prioritize the drug needs of the industry. Their president met with CVM's Center Director, USDA representatives, and the National Research Support Project #7 (NRSP-7) minor species program liaison to develop a long-term plan.

The NAGA has identified 14 animal drugs, already approved in other species, that are needed for the production of game birds. These include coccidiostats, antimicrobials, anthelmintics, and growth promotants. First priority projects will be for therapeutic needs.

Table I

NRSP-7 assists groups such as the NAGA by providing administrative assistance and funding for studies to support minor use approvals. These studies are reviewed by CVM and subsequently published in a Public Master File (PMF). The studies are intended to support the drug's efficacy, safety to the treated animal, safety in human food, and safety to the environment. This data may then be referenced by a pharmaceutical company to support expansion of their label to include the minor use indication. The pharmaceutical companies provide the necessary manufacturing information, and in many cases, other support to complete the New Animal Drug Application. The following drugs have already been approved for use in game birds.

Table II - Drugs Already Approved for Use in Game Birds

NRSP-7 has been instrumental in the approvals of 2 of the 5 drugs approved for use in pheasants, 3 of the 5 drugs approved for use in quail, and for the only drug approved for use in partridges. There are also 4 drugs currently approved for use in ducks. One of the products on the NAGA's list is already an NRSP-7 project which is complete and ready for publication. Two others are already projects with studies in progress. The other proposals are being examined for feasibility and potential sponsor support.

FDA's Center for Veterinary Medicine will continue to meet with NAGA and NRSP-7 representatives to discuss the data requirements that would be necessary to develop the drugs on the prioritized list. Working together, product development plans are being constructed. CVM will also assist NAGA and NRSP-7 by advising and offering suggestions in the design of the necessary studies.

The cooperative efforts of NAGA, NRSP-7, the FDA Center for Veterinary Medicine, and pharmaceutical companies should lead to the eventual approval of the necessary drugs for use in game birds. Achievement of this common goal will answer the needs of the regulated industry while protecting the public welfare without placing an undue financial burden on the pharmaceutical companies. That is good news for everyone.

Minor species issues will be discussed in detail at the 8th Bi-annual NRSP-7 Workshop to be held September 12 and 13, 1996, at the Holiday Inn in Bethesda, MD. The workshop is open to the public and is enhanced by the diversity of attendees. Interested readers are invited to participate in the Workshop.

Readers who wish to obtain further information on game bird production may contact the North American Game Bird Association at the following address: Walter Walker, Secretary, P.O. Box 2105, Cayce-West Columbia, SC 29171, telephone (803) 796-8163.

Further information on the NRSP-7 minor species program may be obtained from

Meg Oeller, D.V.M., FDA Center for Veterinary Medicine, HFV-130, 7500 Standish Place, Rockville, MD 20855, (301) 594-1650.