The FDA is warning healthcare providers that one way counterfeit drugs can slip into the U.S. is when they stray from an approved supply chain to source products. The warning came as the FDA notified 350 doctors in the U.S. that they may have purchased unapproved and possibly counterfeit versions of Allergan's ($AGN) anti-wrinkle drug Botox.
In an announcement about the potentially fake Botox, the FDA urged medical groups to look at their "purchasing practices to make sure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States. Health care professionals, pharmacies and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported."
In the case of the unapproved Botox, the agency said the practices bought the drugs through companies tied to CanadaDrugs.com, the Winnipeg-based online drug supplier that the agency has been after for years. Earlier this year, authorities discovered that a counterfeit of Roche's ($RHHBY) cancer drug Avastin had been shipped to cancer clinics. An investigation by The Wall Street Journal reported that those supplies also came through companies tied to CanadaDrugs.com, the online pharmacy that has morphed into a much larger drug supplier. More than 150 medical practices were warned that they might have bought the counterfeits.
The latest FDA announcement did not mention that in some cases, physician practices could face criminal charges for buying from outside suppliers. A Tennessee doctor in December pleaded guilty to charges of "receiving misbranded drugs with intent to defraud or mislead," after buying $2 million in misbranded cancer drugs from some of the same sources that the FDA says supplied the Botox to U.S. doctors. He faces three years in jail and a $250,000 fine.
- here's the FDA announcement and letter
FDA warns that Botox bought through CanadaDrugs may be fake
FDA's counterfeit drug probe sweeps up cancer
Some 'misbranded drugs' turned up in Avastin probe came from Roche plant
Drugmakers played unintended role in counterfeits hitting
FDA shoots warning across bow of CanadaDrugs.com