The FDA more than a year ago warned cancer docs that it had discovered a counterfeit of Roche's ($RHHBY) Avastin being shipped from a supplier in New York. Now authorities have come down hard on the owners of the company, indicting them on 73 counts for selling more than $17 million worth of fake or unapproved drugs.
According to Newsday, the indictments were handed down for William Scully, 45, of Commack, NY, and Shahrad Rodi Lameh, 40, of Manhasset, NY. The two men pleaded innocent to the charges and were let out on $500,000 bail each. The men ran Pharmalogical, which sold drugs through the name "Medical Device King." The two men face up to 20 years in prison, the forfeiture of up to $17 million and fines of $250,000 each.
The drugs the company allegedly imported illegally included cancer drugs Avastin, Aloxi, Aredia and Rituxan, as well as Remicade. The countries they were imported from included Scotland, Turkey, the United Kingdom, the Cayman Islands, Canada, the United Arab Emirates and Finland, the indictment said.
In a warning to healthcare providers in February 2013, the FDA said that a counterfeit of Roche's cancer drug Altuzan had been shipped to some providers from Medical Device King. Altuzan is the trade name used in Turkey for Roche's Avastin. Lab tests found the shipped products contained no active ingredient. The agency said that even if the Altuzan (bevacizumab) was not counterfeit, only Roche's Avastin is approved by the FDA for sale in the U.S. The FDA said that no patients received the fake.
The FDA and Department of Justice have several running cases against companies like Medical Device King that import unapproved drugs. They have also gotten convictions for some doctors who knowingly bought the products to get the deep discounts they were being sold for.
- read the Newsday story