At the end of June in 2013, the FDA sent warning letters to close to 800 medical practices throughout the United States concerning their business exchanges with a black market medication wholesaler called Medical Device King/Pharmalogical. The subsequent investigation of Medical Device King has resulted in counterfeit drug and fraud charges being leveled against the president and vice president of the Great Neck drug wholesaler.
One year after the FDA warned health care providers about counterfeit cancer medication being found in shipments from Medical Device King, the Department of Justice (DOJ) announced charges against the president and vice president of the company. According to the DOJ, William Scully and Shahrad Rodi Lameh have been charged “with multiple counts of conspiracy, mail fraud, wire fraud, distribution of misbranded and counterfeit prescription drugs, trafficking in counterfeit goods, and smuggling.”
The DOJ reports that the defendants are alleged to have sold counterfeit cancer medication to an oncology practice located in Iowa. The defendants are also alleged to have sold black market IUDs that were supposedly imported from Finland. None of the drugs or medical devices sold by Medical Device King were FDA approved.
As a result of this, the FDA was forced to warn 776 medical practices in 46 states, plus one in the U.S. Virgin Islands and four in Puerto Rico that they may have received misbranded or counterfeit drugs in their purchases from Medical Device King/Pharmalogical. In the letter, the FDA stated that “The U.S. Food and Drug Administration (FDA) has received information indicating that your medical practice may have received prescription drug(s) distributed by Medical Device King (MDK), a distributor that is not licensed in any state. FDA is very concerned these products may cause harm to patients, because they may be unsafe or ineffective.”
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The FDA letter expressed particular concern about counterfeit versions of the cancer medication Avastin (bevacizumab), which is labeled “Altuzan” in other countries. “In particular, counterfeit units of product labeled as Roche’s “Altuzan (bevacizumab) concentrate for solution for infusion,” and distributed by MDK, have been discovered in the United States. Units of this product labeled as “Altuzan (bevacizumab) 400 mg/16 mL,” with the lot numbers B6022B01 or B6024B01, are particularly suspect. FDA lab tests have confirmed that at least one batch of such product distributed in the U.S. contains no active ingredient.”
The Reno-Gazette Journal reports that at least one oncology practice in Carson City received counterfeit cancer medication, and that some of the medications and devices sold by Medical Device King had improper labeling, while others were labeled with the names of foreign versions of drugs that are not approved for use in the United States.
News Long Island 12 reports that Scully and Lameh are facing 73 federal charges in total. According to the DOJ, if they are convicted, they will each face a maximum sentence of 20 years, forfeiture of $17 million in assets, and a $250,000 fine.
Said FDA OCI Special Agent-in-Charge Mark Dragonetti, “The FDA will remain vigilant in our efforts against those who would threaten the integrity of the prescription drug supply chain by introducing counterfeit and unapproved products for their own financial gain. We commend the work by the U.S. Attorney’s Office, and together we will continue to pursue those who jeopardize the health of the public.”