Two oncology specialists in California, US, have agreed to plead guilty to federal charges related to the distribution of unapproved copies of a Roche cancer medicine.
Drs Stanley Rossman and Mark Goldstein are expected to plead guilty later today to obtaining more than $1m-worth of Altuzan – an overseas name for Roche’s big-selling Avastin brand – that was at the centre of a major falsified medicines scandal a few years ago, according to an Orange County Register report.
The two physicians could face suspension or revocation of their licenses to practice medicine and up to $1.2m in fines, according to the news platform.
In 2012, counterfeit vials of Avastin (bevacizumab) bearing the Turkish trade name Altuzan and Turkish packaging were discovered in the US market. Analysis revealed some of the vials contained no active ingredient, which could suggest they were counterfeit.
A subsequent FDA investigation revealed that the distribution of the falsified Altuzan in the US was fairly broad, with nearly 100 physicians, mostly in California, purchasing the bogus cancer drug. Distributors were forced to stop selling drugs to US physicians and at least 11 criminal proceedings were brought against the principals.
The case prompted Ronald Noble, secretary-general of the international police organization Interpol to describe the case as "a watershed moment for law enforcement to recognise that this is not a problem that can be restricted to one part of the world. It let the US know it's not immune to [falsified] drugs."
In 2014 and 2015, two Turkish nationals were sentenced to jail terms in connection with the case, after being found guilty of smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the US.
The falsified Altuzan packs continued to crop up in the supply chain in the years after the falsification was first discovered. In 2017, for example, the Cyprus' Ministry of Health has revealed that three batches of suspect Altuzan had been discovered.
It's not clear why it has taken so long for the case involving Rossman and Goldstein has taken so long to come to this stage.
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