Retired sales rep sentenced for selling Rx drug samples

FDA Consumer, July-August, 1997 by Paula Kurtzweil

A retired drug company salesman became the sixth person convicted and sentenced in an illegal money-making scheme to sell prescription drug samples to retail pharmacists and others in the Buffalo, N.Y., area.

At press time in May, Edward Mikula, of Cheektowaga, N.Y., was serving seven months in federal prison for violating the Prescription Drug Marketing Act of 1988. The law bars the sale, purchase, trade, or the offer to sell, buy or trade prescription drug samples. Such practices are considered hazardous because of the risk of counterfeit, adulterated, misbranded, subpotent, or expired drugs being sold to consumers. They also constitute fraud against legitimate prescription drug sellers.

Mikula, a former Wyeth-Ayerst Laboratories sales representative who retired from the company in 1987, was convicted in the U.S. District Court for the Western District of New York in July 1996 and sentenced in December. The evidence showed that between 1988 and 1993, he sold prescription drug samples of Premarin, Procardia, Inderal, Lodine, Feldene, Reglan, and others made by various companies, including Wyeth-Ayerst, Lederle Laboratories, A.H. Robins Co., and Pfizer Labs, to former business acquaintances, such as pharmacists and other pharmaceutical purchasers.

"He sold anything he could get his hands on," said Raymond Kent, a compliance officer in FDA's Buffalo district office.

Kent heads a team of FDA investigators that, along with FBI and Internal Revenue Service agents, is "heavily investigating" the sale of prescription drug samples in the Buffalo, N.Y., area, Kent said. Those previously convicted and sentenced include pharmacists, a dentist, a pharmaceutical salesman, and a retired hospital administrator.

Mikula's role in the scheme came to light earlier in the investigation when his name was linked in documents and conversations with others. Sifting through various records and piecing together various bits of evidence, investigators learned that Mikula, according to a grand jury indictment, met "on various occasions" with a co-conspirator to buy drug samples from another co-conspirator. Mikula refused to name his co-conspirators.

The indictment said Mikula and his co-conspirators sold drug samples in their original packaging or in plastic sandwich bags and other containers.

The indictment cited five instances in which Mikula received cash or checks for amounts ranging from $500 to thousands of dollars for selling drug samples. But, Kent said, "We don't know how much he made in all."

A previous defendant who pleaded guilty to his involvement in the Buffaloarea drug diversion scheme and who spent time in a minimum-security prison, earned an estimated $80,000 from his illegal activities.

A grand jury handed down the three-count indictment against Mikula in May 1995. He pleaded guilty to all three counts July 22, 1996.

Citing the "seriousness" of Mikula's offenses, his "misguided belief" that it would be unfair to cooperate with the investigation, and his apparent belief that he had "done nothing wrong," District Judge Richard Arcara sentenced Mikula to the maximum allowed under sentencing guidelines.

Upon completing his prison term, Mikula, who is in his early 70s, will spend seven months under home confinement and serve one year of supervised release. He also was fined $1,000.

FDA's investigation of the prescription drug diversion scheme continues.