- The Washington Times - Monday, September 8, 2003

Life:

lack-and-white Holsteins grazing contentedly in a grassy field on the 160-acre site of the Food and Drug Administration’s Center for Veterinary Medicine are doing their bit to protect the American consumer, just like scientists inside the nearby laboratories.

So is the stock of large Atlantic salmon swimming in carefully monitored tanks inside CVM’s aquaculture building.

Cows and fish don’t work quite as hard as their human overseers — certainly not with the same degree of diligence — but they are part of everyday life at the center, a state-of-the-art complex in suburban Laurel.

The fish are fed tiny nutrient-rich pellets regularly. The cows are milked in the barn twice daily, just like at a commercial dairy. Only here, fresh milk goes to lab research projects that, among other things, give CVM drug reviewers the background information they need to evaluate the safety and behavior of drugs used on animals. The routine tests used to screen for the presence of antibiotics in milk are themselves tested for accuracy and reliability.

Those healthy salmon specimens can be checked through catheterization and other means for reactions after being treated with drug potions similar to what might be used to cure diseases among fish in an overcrowded hatchery.

Since few drugs have been developed by commercial sponsors for use in the booming business of fish farms, at least not to the point of seeking FDA approval as required by law, a CVM veterinarian heads up pilot programs to gather data about how to test for the safety of drugs and other products. The labs also study methods used to determine the safety of imported food products, such as seafood.

Directly or indirectly the FDA, which oversees the safety and efficacy of numerous consumer goods, is in your blood, your diet, your cell phone, your medicine cabinet and even your pet. Most headlines about agency activities have to do with decisions involving human health and welfare. Unknown to many people, animal care, chiefly pets and food-producing animals, comes under its purview as well.

Decisions made on animals’ behalf are typical of some of the agency’s more unusual work. Approval of a stair-climbing wheelchair as a human medical device, which was granted last month, sounds novel enough, as does approval of a growth hormone for children to improve their short stature. Just as surprising, perhaps, was FDA endorsement in May of the first injectable chemical sterilization product for male puppies.

The animal product, sold under the name Neutersol and available only to veterinarians, took nearly 10 years to bring to market, according to Dr. Stephen Sundlof, director of CVM. The smallest of FDA’S seven divisions, it has only 320 out of the agency’s total of nearly 10,000 employees.

“[The FDA] regulates more than 20 percent of the U.S. economy,” says Peter Pitts, FDA associate commissioner for external relations. Their responsibilities have increased with the establishment of the Department of Homeland Security. Not only does FDA now oversee the nutritional safety of imported foods, it must also be sure such foods contain no elements likely to threaten national security.

The FDA, a branch of the Department of Health and Human Services that calls itself a science-based law enforcement agency, is headquartered in Rockville with offices scattered across the country. The annual $1.2 billion budget amounts to about $4 per taxpayer a year.

What the agency does and does not regulate is confusing to outsiders. For some reason, possibly a quirk in the law, the U.S. Department of Agriculture regulates animal vaccines while the FDA’s CVM regulates animal drugs.

“I must admit it doesn’t make a lot of sense,” Dr. Sundlof says.

Some everyday consumer products such as cosmetics and dietary supplements can generally be marketed to the public with no prior approval, according to the FDA’s comprehensive Web site (www.fda.gov). Should any product prove harmful or defective later, however, the agency moves in.

The FDA last year issued an alert when some imported dog chews made of animal parts were found to be contaminated with salmonella, which is harmful to both dogs and humans.

“Pig ears are considered food,” Dr. Sundlof explains. “If it is found to be unsafe once it is on the market, we can take action.” (The FDA oversees food products in a way that is different from drugs, says FDA spokesman Brad Stone. Whenever a new type of food is introduced on the market, the agency by law must see that it is safe to eat and is properly and accurately labeled.)

The FDA does not make drugs, nor does it conduct clinical studies. Instead, the agency works with and eventually verifies manufacturers’ approaches and data on the development of a new drug or product. This entails an elaborate and expensive series of steps that can cost an average of $50 million and take many years. Manufacturers bear the cost in hopes of recouping its money from sales.

Some of the original lab work done by the agency involves reviewing items that may have previously have won approval but whose uses are being adapted for new purposes.

CVM issues about 80 product approvals yearly, according to Dr. Sundlof. “Not all of them are brand new drugs but are new indications for existing drugs — sometimes for one species in animals and not in another,” he says. “In most cases, drugs are approved for human use and then there is a trickle-down effect for animals.” He cites as an example the case of a pill approved for treating ulcers in humans that also can work for horses. “Horses get ulcers, too,” he says.

Sometimes the opposite occurs. A drug developed and approved first for animals, such as drugs used to treat parasitic conditions, will then be approved for humans.

“Breakthroughs on the human health side provoke us to find what can be done to improve animal health,” says Ron Phillips, spokesman for the Washington-based Animal Health Institute, a trade organization representing manufacturers of animal drugs and products. It helps that many, if not most, animal health companies are divisions of human health companies.

“The requirements for approving a drug on the animal side [are] almost identical with the human side; some of the basic science done is the same,” he says. “Original research is done by companies, but all the data has to be examined and approved by the FDA. It’s not like companies operate in a vacuum. Before tests are even done, the FDA has to approve the way they are done. Research is expensive so you don’t want to waste money.”

The FDA often does surprise inspections to see whether companies are conducting clinical studies properly, Dr. Sundlof notes.

The chemical for neutering puppies, which is available primarily for use by humane shelters that can’t afford surgical neutering, is not a traditional product, he admits.

Another unusual drug now in the pipeline, is an injection that can sterilize the deer population encroaching on residential areas and endangering themselves in the process. It’s unusual, too, to find the Humane Society of the United States being a formal drug sponsor as it is on this one, according to Allen Rutberg, a research professor at the Tufts Center for Animals and Public Policy in North Grafton, Mass. The society is collaborating with a number of research facilities, he says.

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