SAN DIEGO (CNS) - The operators of a Pennsylvania oncology practice admitted Thursday in federal court in San Diego to buying, over a several-year period, cancer drugs unapproved for use in the United States.
In light of the guilty plea, Magistrate Judge Karen Crawford ordered Pittsburgh-based Jan C. Seski M.D. & Associates to pay a $100,000 fine and place two medical-journal advertisements warning of the dangers of unauthorized medications, according to U.S. Attorney Laura Duffy.
Officials with the 40-year-old medical practice conceded that they ordered $973,795 worth of foreign versions of the cancer drugs Eloxatin, Gemzar and Taxotere from GlobalRxStore.com between December 2008 and May 2011, and had them shipped by Oberlin Medical Supply of San Diego. The medications were unapproved by the U.S. Food and Drug Administration for domestic use, according to prosecutors.
The manner or degree to which the practice may have utilized the substances was unclear.
According to sentencing documents filed with the court, the criminal case came to light when federal agents visited Oberlin Medical Supply's San Diego offices. Maher Idriss, owner of the supplier, had been working with GlobalRxStore.com to supply foreign oncology drugs to doctors throughout the United States.
At Oberlin, the agents discovered numerous boxes of oncology drugs that bore labeling indicating that the products had been manufactured in foreign countries and were not sanctioned for use in the United States. The medical practice provided agents with a copy of a label for boxes of Gemzar received from GlobalRx.
The tag indicated, in English and Turkish, that the product was manufactured by Eli Lilly in Fegershaim, France. It did not bear the words "Rx only," as required by the FDA, nor include National Drug Code numbers used for Medicare billing in this country. Also, it was a different color than FDA-approved labels for the U.S. version of the product.
The medical practice also surrendered a drug vial that was in one of the boxes, and it was found to have the active ingredient used in the manufacture of Gemzar. Without such testing, however, there was no assurance that other foreign drugs purchased by the defendants outside the closed chain system established by the FDA contained the key ingredient, according to prosecutors.
Seven months ago, the FDA warned physicians about batches of counterfeit Avastin, an oncology drug that had been marketed to U.S. doctors. The sales of the imitation drug, which contained none of the active ingredients that are in the genuine medication, was the third such incident that had occurred over a period of several months, according to government officials.