A new wrinkle has developed in the fight by the FDA against counterfeit drugs. An unapproved, foreign version of the 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 agency said in a notice on its website that the products were offered with names like "Onlinebotox" but were being offered 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 ($AGN) told Reuters that the drug must be stored and distributed following exacting standards. The news service pointed out that in 2004, four people ended up in the hospital with poisoning after a doctor injected them with unapproved botulinum toxin, which he was selling as Botox. The drug is prescribed for uses beyond its wrinkle-relieving properties and is approved for treatment of headaches and for overactive bladders, as well as other conditions. Allergan in 2012 sold about $1.8 billion worth of Botox.
While counterfeiters still focus primarily on so-called lifestyle drugs, like erectile dysfunction drugs Viagra and Cialis, they have been branching out into higher priced products where the risks to patients are greater. Last year, the FDA put out alerts that fraudulent versions of Roche's ($RHHBY) cancer treatment Avastin had been sold to physician practices throughout the U.S. Foreign versions of some other Roche cancer drugs were also found in the U.S. Federal authorities prosecuted one case last year in which a shipment of foreign-made "cold chain" cancer drugs arrived at a doctor's office as a "gooey mess."
This is not the first time for unapproved Botox to be pedaled to doctors, either. In December, the FDA warned 350 doctor practices that supplies of Botox they bought through companies with ties to Internet pharmacy CanadaDrugs.com were at best unapproved foreign versions--and therefore had been sold to them illegally--and could in fact be counterfeit.
- here's the FDA warning
- read more from Reuters