Three individuals have been formally charged in the US for their alleged involvement in the counterfeiting of Pfizer's Lipitor (atorvastatin) as investigators try to unravel the intricate web of conspirators behind the case.
The Lipitor case emerged earlier this year and prompted a US Food and Drug Administration's drive to prevent drug counterfeiting. The number of fake drug cases is still low, at around 20 cases a year, but this represents a significant increase over the 1990s when around five cases a year were uncovered.
The defendants are all accused of receiving kickbacks and commissions from a drug wholesaler, Albers Medical, believed to be involved in the Lipitor scam. However, neither of the indictments refers specifically to fake Lipitor and investigators believe it will take some time to find the source of the counterfeit versions, which passed through a number of distributors on their way to US consumers.
In May, Pfizer filed lawsuits against Albers and another wholesaler, Med-Pro, for their role in handling the fakes. Albers is protesting its innocence in the affair, and has filed its own lawsuits against 10 other distributors in the chain for its 'inadvertent' purchase and distribution of counterfeit Lipitor. Med-Pro has since filed for bankruptcy.
Although there are only a few counterfeiting cases uncovered in the US each year, the FDA was concerned by the scale of the Lipitor scam, which led to more than 200,000 bottles of Lipitor being recalled.
The case has also focused attention on the issue of drug re-packaging. This involves the bulk purchase of medicines outside the US, where they are often cheaper, and their re-packaging into smaller bottles that can be labelled for US distribution. There is some evidence that this may have been the route of entry for at least some the fake Lipitor, leading for calls to ban the trade and measures to allow the tracking of prescription medicine batches.