Another counterfeit drug may have made its way into the U.S. through Canada.
The FDA warned 350 medical practices that what they believed was the wrinkle remover Botox was unauthorized and could be counterfeit. The letter says that because they are unapproved foreign versions of Allergan's ($AGN) Botox, they have not been shipped properly and could be fake. The agency ordered them to stop using the products.
The agency said the practices bought the drugs through companies tied to CanadaDrugs.com, the Winnipeg-based online drug supplier that the agency has been after for years. Earlier this year, authorities discovered that a counterfeit of Roche's ($RHHBY) cancer drug Avastin had been shipped to cancer clinics. Tests of those drugs found that they contained no active ingredients. An investigation by The Wall Street Journal reported that those supplies also came through companies tied to CanadaDrugs.com, the online pharmacy that has since morphed into a much larger drug supplier. More than 150 medical practices were warned that they might have bought the counterfeits.
In its latest warning, the FDA urged medical groups to look at their "purchasing practices to make sure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States. Health care professionals, pharmacies and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported."
The agency didn't mention that in some cases doctors and medical practices might be prosecuted for their purchasing practices. Earlier this month, Dr. William R. Kincaid, 67, the principal owner of McLeod Cancer and Blood Center in Knoxville, TN, pleaded guilty to charges of "receiving misbranded drugs with intent to defraud or mislead." McLeod bought unapproved cancer meds from some of the same companies the agency is now warning sold the unauthorized Botox. According to federal authorities, Kincaid acknowledged that the practice bought $2 million in misbranded drugs from a Canadian wholesaler to save money and then charged federal health programs full price. Among the misbranded drugs--some of them made at foreign plants not approved by the FDA--were Abraxane, Alimta, Avastin, Eloxatin, Gemzar and Rituxan. He faces three years in jail and a $250,000 fine.
- here's the FDA announcement and letter