Animal Drug Shortages, Focus on Fish, Alternative Meat Animals

by Food and Drug Administration (FDA)

(Page 2 of 3)

Animal Drug Shortages

The continued shortage of minor use drugs not only poses a serious threat to the health of animals — it also may set in motion a chain of events that could adversely affect nearly every American.

First, American farmers could find their livelihoods threatened, since unhealthy animals create significant losses to producers. Second, the American economy could face a worsening trade deficit, since more food animal products would need to be imported to make up for the loss. And third, American consumers could be exposed to a poorer quality of some imported food, since certain animal products originate in countries whose safety and environmental laws may be less stringent than U.S. standards.

So why the shortage of minor use drugs? "There is no economic incentive for pharmaceutical companies to get approval for these drugs since they affect a small population," says Sundlof. "Companies may feel that the size of the market doesn't justify the drug development costs."

Animal drugs must be approved for each species they are intended to treat. Just to add a new species to the label of an existing drug costs $2 million to $8 million. To get a brand-new drug approved, it costs a drug company an estimated $20 million and 8 to 10 years of concentrated research efforts.

Focus on Fish

Fish farming, or aquaculture, is one of the fastest growing segments of American farming, says the USDA. Yet to satisfy America's taste for seafood, the United States imports over $9 billion worth of fish each year — more than three times as much as it exports.

"The task for domestic producers is to supply a superior quality product at a reasonable cost," says MacMillan. "What the U.S. aquaculture industry needs is improved health-management systems. We need more vaccines and we need to be able to prevent infectious diseases. In the interim, we need methods to treat sick fish."

The USDA estimates losses of more than $100 million each year, attributable to 50 different fish diseases.

Aquaculture organizations and government agencies are investing heavily in drug research to help ease future losses to industry. The International Association of Fish and Wildlife Agencies, U.S. Fish and Wildlife Service, U.S. Geological Survey, USDA Minor Use Animal Drug Program, and commercial aquaculture operations are among those working in partnership to increase the availability of treatments for fish diseases.

Japan, a major seafood producer, has more than two dozen drugs or combinations of drugs approved for use in its aquaculture industry, according to the American Veterinary Medical Association. The United States has just six drugs approved for use in food fish.

"Water quality in many developing countries is not as good as ours," says Roz Schnick, who helps producer groups and pharmaceutical and chemical companies work together to gain drug approvals. "This creates more stress on the animals, and with stress comes disease so they have to use more drugs," says Schnick. "In the United States, we don't need a lot of drugs — just a basic medicine chest that we are currently attempting to achieve through proper approval procedures."

Schnick reports that through the efforts of federal and state government agencies and a consortium of aquaculture organizations, the medicine chest will soon fill up — four new aquatic animal drug applications and two supplemental applications are close to being submitted to the FDA for approval.

Additional aquaculture drug research may be expedited through "species grouping." In aquaculture, where there are hundreds of species, it is not practical to test a drug on all of them, says the FDA's Oeller. Researchers are trying to group similar species of fish in order to test drug effectiveness, safety in target animals, and safety in human food. This grouping may yield representative species whose data can be used to support including similar species on the label of a new animal drug.

Fish are not the only animals that can benefit from species grouping research, says Oeller. Other groups may include game birds (pheasants, partridges, quail), deer (white tail, red deer, elk), and ratites (ostriches, emus). "It may be that the research will show that the species are not similar, or are not similar for some classes of drugs," says Oeller. "Learning what is and is not suitable for grouping will be very valuable in making drug approval for minor species more efficient."

Alternative Meat Animals

Although much of its minor species research centers on aquatic animals, the Minor Use Animal Drug Program also is investigating the needs of other animals used in agriculture. Some of this research is motivated by the needs of American farmers seeking healthful alternatives to the traditional red-meat market.

Meats from ostriches, emus, bison, deer, and elk have some nutritional benefit over other red meats, according to a USDA-funded study conducted at the University of Wisconsin-Madison. "These alternative meats, like traditional meat and poultry, are high in protein," says Dennis Buege, Ph.D., lead study researcher. "Their cholesterol content is similar to the other meats and poultry. However, they tend to be lower in fat than beef, pork and dark meat chicken, and higher in iron than beef, pork, and light and dark meat chicken." (See "How Meats Measure Up.")

The Minor Use Animal Drug Program has conducted research to support the approval of a drug for bison, and several projects are in progress for deer and elk. As yet, there are no drugs approved to treat flightless birds known as ratites, but the program recently has received several requests from this growing industry.

The program is researching treatments for diseases in sheep and goats, also minor species. A number of drugs to treat these animals have been approved, but more are needed, particularly to aid America's declining sheep industry.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.