SecuringPharma reports that Japan’s counterfeit Harvoni incident has been traced to “small wholesale firms with a reputation for selling drugs from unreliable sources.” Japanese authorities believe “back-channel, cash only” wholesalers were responsible for distributing the fake hepatitis C virus treatment, according to a local newspaper, the report adds. But is our country susceptible to this type of counterfeiting incident? Well, we should be very concerned. There’s no room for complacency, despite enhancements brought about by the Drug Supply Chain Security Act (DSCSA), and here’s why.
First, our supply chain is replete with corrupt smaller (i.e. secondary) wholesalers, perhaps not unlike those in Japan. There have been many examples throughout the years where such wholesalers were implicated in the distribution of counterfeit, stolen, and diverted drugs from illicit sources. For instance, licensed wholesale distributors in Tennessee and New York were implicated by FDA in the well-publicized counterfeit Avastin and Altuzan incidents which first surfaced in early 2012. And even though pharmacies, doctors, and other “trading partners” are now prohibited by the DSCSA from purchasing drug products from unlicensed/unauthorized sources, who is going to make sure they are not still doing so? Without a cop on the beat, criminal supply chain schemes involving corrupt doctors and pharmacists will continue to go undetected and undeterred.
In October 2016, a Long Island, New York pharmacist was sentenced to 8 to 24 years in prison for his role in selling diverted HIV drugs worth close to $274 million. Do you think this pharmacist ever asked his illicit suppliers for a license, or a pedigree (this case pre-dated the DSCSA’s product tracing requirements)? Of course not! And do you think he would have known if counterfeit drugs (think counterfeit Harvoni) had been substituted for the diverted drugs he bought? Not likely.
This is an all-too-likely scenario that should keep regulators up at night. Until the presence of corrupt trading partners within our supply chain becomes more of a state and federal priority, we can be assured that it’s just a matter of time before our country has to deal with a counterfeit Harvoni incident of its own.