In 2003, the Food and Drug Administration (FDA) ordered the recall of some 18 million doses of Lipitor when counterfeit pills were found in the United States.
An investigation by the FDA and the Justice Department has centered on a major pharmaceutical distributor, H. D. Smith Wholesale Drug of Springfield, Illinois, which claims it was unwittingly involved in the scheme as a result of the actions of a “rogue employee” who purchased the fake Lipitor pills from an unauthorized wholesaler.
According to documents filed by the Justice Department in a civil case in federal District Court in West Virginia, an indictment of the company may be forthcoming as early as August.
To date, the Lipitor case has resulted in eight indictments and five convictions in what has been the largest counterfeiting investigation ever by the FDA’s Office of Criminal Investigations. The counterfeit Lipitor pills have been traced to Costa Rica through a series of sales by secondary wholesalers.
Lipitor, the world’s largest-selling pharmaceutical with annual sales in 2004 of $10.86 billion, is only one of many drugs to have been caught up in the growing problem of counterfeit medications involving the “secondary drug market.”
The Lipitor case has spawned several civil actions as well as the criminal investigation. Among the cases against H. D. Smith is one by Rite Aid which had to recall all of its Lipitor stock because it was unable to distinguish the counterfeit Lipitor pills from the real ones it had purchased. Rite Aid bought 3.8 million Lipitor pills from H. D. Smith for approximately $6.2 million.
In addition, many consumers have brought personal injury lawsuits involving the fake drugs.
Now, the Medicines and Healthcare Products Regulatory Agency (MHRA), which is the UK equivalent of the FDA, in conjunction with Pfizer, has announced a recall of 20mg Lipitor tablets as a result of finding counterfeit versions of that particular dosage of the drug.
The fake tablets can be identified because they do not come in the sealed packages used to market the real 20mg pills.
Since 2004, the UK too has been encountering a growing problem with counterfeit medications. Previously, fake batches of Cialis and Reductil were discovered there.