Dimetridazole

A federal grand jury recently returned an 11-count indictment against an Iowa veterinarian for manufacturing and distributing animal drugs in violation of FDA regulations. If convicted on all counts, Andrew J. Cotten, D.V.M., faces a maximum sentence of 41 years in prison and fines of up to $2,750,000.

The May 16 indictment is part of an intensive FDA and U.S. Department of Justice crackdown on illegal sales of animal drugs. Acting FDA Commissioner James Benson has called the Cotten case an important step in dismantling the illegal animal drug trade."

Nearly 30 individuals and four corporations have been convicted in the past two-and-a-half years on various charges involving conspiracy, smuggling, false statements, and violations of the Federal Food, Drug, and Cosmetic Act. More than 40 tons of unapproved animal drugs have been seized.

According to Jan Longenecker, FDA's expert investigator on black-market animal drug cases, the agency learned of Cotten's alleged activities in 1982 from a legitimate animal drug manufacturer. The competitor reported to the agency that Cotten was obtaining from foreign sources a pure powder form of the animal wormer levamisole. He then reportedly manufactured and distributed an unapproved version of the drug.

Around the same time, according to a federal government official, Cotten's name was linked to distribution of illegal animal drugs obtained through numerous other sources. When asked by federal investigators where they obtained certain drugs, salesmen said they bought them from Cotten.

FDA investigators immediately started to review Cotten's operation. Cotten is the principal partner in several veterinary companies, including Kossuth Vet Supply, Inc., in Algona, Iowa. When, on several occasions, Cotten refused entry to FDA investigators, inspection warrants were obtained in January and August 1984 from a federal magistrate in the Northern District of Iowa. In June, FDA sent Cotten a warning letter advising him that he was an unregistered manufacturer of unapproved animal drugs manufactured without adequate controls.

During the August inspection, FDA investigators found empty drums labeled with the names of bulk animal drugs (including the antibiotics oxytetracycline and dimetridazole) that Cotten did not have approval to distribute.

This was the first big break" in the Cotten case, says Longenecker. Airfreight labels on the drums indicated that they had been shipped from Toronto, and investigators were able to trace drugs involved in distribution through Canada.

(According to Longenecker, it is typical in black-market animal drug distribution for individuals to buy, at discount prices, foreign-made bulk drugs that do not comply with the requirements of the FD&C Act. They then have the drugs smuggled into the United States-in this case, allegedly through Canada-where they sell them as generic equivalents of approved drugs. The black marketers, however, neglect to submit the drugs to FDA to demonstrate generic equivalence through the required approval process.)

Soon after the August inspection, Cotten signed a statement in which he agreed to cease all "prohibited practices."

The indictment charges Cotten with the following violations:

* Conspiring to violate the FD&C Act by manufacturing and distributing adulterated and misbranded animal drugs. In the conspiracy, Cotten allegedly entered into a business arrangement with Jeffrey Engel, of Omaha, Neb., who pled guilty last January to smuggling and distributing illegal animal drugs. Engel allegedly arranged to obtain foreign drugs, which Cotten then reportedly distributed through United Vet Supply, one of his operations.

Examination of Cotten's bank accounts show records of checks for the drugs he bought from the intermediary company Engel established as a front to sell illegal drugs to Cotten:

November 1982: payment of 33,000 to MWM Chemical Company for chloramphenicol, an animal antibiotic now banned for use in food-producing animals because the drug can cause aplastic anemia in humans. MWM, New York, N.Y., now known as Zetapharm, pled guilty in January 1989 to violations of the FD&C Act for supplying unapproved bulk animal drugs to Engel, Cotten, and other black marketers.

June 1983: $54,000 paid for 2,000 kilograms of the animal drug dimetridazole, a chemical since banned for use in food-producing animals because of its cancer-causing properties in animals and concern that residues in meat might cause cancer in humans.

October 1983: $18,900 paid for sulfadimethoxine, an antibiotic illegally used by Cotten to manufacture unapproved animal drugs.

April, August, September, and November 1987: four payments totaling $42,445.50 for the animal antibiotic gentamicin.

Cotten also allegedly distributed unapproved dimetridazole and oxytetracycline for resale in Iowa. Longenecker says that FDA learned of this suspected offense during its surveillance of the veterinarian. Investigators observed that on Monday mornings Cotten would load up two or three truckloads of drugs and make deliveries to veterinary clinics in Iowa and surrounding states.

In June 1984, after following one of Cotten's salesmen, FDA investigators inspected and sampled the contents of Cotten's truck and found numerous unlabeled and unapproved animal drugs.

* Distributing drugs not properly labeled with the names and locations of the manufacturer, packer and distributor, or with adequate directions for use of the product.

Cotten also is charged with distributing unapproved and misbranded carbadox on three occasions in 1986. According to one government official, Cotten obtained a pure form of this antibiotic through illegal channels. In this form, the drug is more explosive than gunpowder, presenting a danger to people mixing it. The legitimate U.S. manufacturer of carbadox processes the drug in a 30 percent diluted form.

* Falsifying records to conceal his activities. The indictment describes a scam in which Cotten allegedly sold animal drug products containing carbadox, but covered up the transaction by providing an intermediary in the sale with false invoices representing the carbadox as vaccines.

* Manufacturing and repacking animal drug products for commercial sale without proper FDA registration. The establishments for these operations were Kossuth Veterinary Supply, Inc., Thorn's DVM Supply, and Kossuth Vet Clinic, located in Algona, Iowa.

At the time of this writing, Cotten's trial was scheduled for Nov. 6, 1990.

COPYRIGHT 1990 U.S. Government Printing Office
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