The FDA has been fighting an assault on the legitimate pharma supply chain on two major fronts in the last year. Scammers have been selling to doctors outright counterfeits of high-value drugs, like Roche's ($RHHBY) cancer treatment Avastin. They have also been pedaling imports of foreign-made versions of some drugs, convincing doctors they are getting equal quality at a discount price. Now a hybrid has appeared.
According to a notice on the FDA website, an unapproved, foreign version of Allergan's ($AGN) cosmetic treatment Botox has shown up in the U.S., this time in counterfeit packaging that makes it appear to be the same product that is made for the U.S. market. The products were offered with names like "Onlinebotox" but were being marketed on the cheap through "blast faxes."
While the drug may be a version approved for use in other countries, the FDA said that because it did not come through the approved supply chain there is no way to guarantee its quality or its safety. Botox is a sterile, purified version of the same toxin that causes botulism, and maker Allergan told Reuters that the drug must be stored and distributed following exacting standards. Federal authorities last year prosecuted a case in which a shipment of foreign-made "cold chain" cancer drugs arrived at a doctor's office as a "gooey mess."
Federal authorities have reported a spate of foreign-labeled drugs showing up in the U.S., some of which have turned out to be counterfeits. Foreign labels are a giveaway, and the new technique of camouflaging them with counterfeit packaging comes after the feds extracted guilty pleas in February from two men they said imported and sold $7 million worth of oncology drugs from Turkey, Pakistan, India and elsewhere. At about the same time, the FDA was warning doctors that Altuzan sold to doctors by a company in New York was fake and contained no active ingredient. Altuzan is the trade name in Turkey for essentially the same Roche drug that is sold as Avastin in the U.S.
While counterfeiters still focus primarily on so-called lifestyle drugs like erectile dysfunction products Viagra and Cialis, they have been branching out into higher priced products where the risks to patients are greater. Last year, the FDA put out alerts that fraudulent versions of Roche's cancer treatment Avastin had been sold to physician practices throughout the U.S. In December, the FDA warned that Botox some doctors had bought through companies with ties to the Internet pharmacy CanadaDrugs.com might be counterfeit.
- here's the FDA warning
- here's more from Reuters