The Food and Drug Administration (FDA) and the United States Attorney for the Western District of Missouri, in Kansas City, have announced the indictment of 11 individuals, a drug re-packer, and two wholesale distributors in cases related to the sale of counterfeit Lipitor, the most widely prescribed cholesterol reducing drug.
The indictment alleges numerous charges including conspiracy to sell counterfeit, illegally imported and misbranded drugs as well as conspiracy to sell stolen drugs.
The conspiracy involved the manufacture of counterfeit Lipitor at a secret facility in Central America, the purchase of genuine Lipitor intended for distribution in South America, and the illegal importation of both products into the U.S.
"This case demonstrates that the FDA will take the necessary steps to protect the drug supply in America," said FDA Commissioner Dr. Lester Crawford. "I am pleased that the U.S. Attorney’s Office and FDA have been able to put together this case and stop these fraudulent schemes to sell pharmaceuticals of unknown safety and efficacy to the public."
In 2003, Albers Medical Distributors, Kansas City, MO, (a drug wholesaler) distributed over $20 million in illegally imported and counterfeit Lipitor that was sold to H.D. Smith Wholesale Drug Company (Wood Dale, IL).
H.D. Smith distributed these Lipitor tablets throughout the U.S. The counterfeit Lipitor was repackaged by Med-Pro, Lexington, NE., a drug re-packer. All three participants in this scheme were named in the indictment today. It is believed that these particular counterfeit Lipitor products are out of circulation.
In addition, it is alleged in the indictment that members of the conspiracy distributed pharmaceuticals stolen from GlaxoSmithKline and Roche Pharmaceuticals and counterfeited drugs.
The FDA’s Office of Criminal Investigation (OCI) was able to put together the case by tracing back the various steps in this scheme. OCI was able to document where the chemicals and products came from, where the counterfeit was being manufactured, and how it was distributed.
Working together with the U.S. Attorney’s Office in the Western District of Missouri, these findings led to today’s indictment of all parties involved.
The FDA and federal law enforcement authorities are also becoming increasingly concerned with the sale of counterfeit drugs over the Internet and at pharmacies in Mexican border towns.
Although the operators of several Internet (and mail-order) operations have been arrested recently and charged with illegal drug sales through online pharmacies, the authorities have been frustrated by the fact that new websites are up and running almost immediately.
The Mexican problem is also becoming quite serious since counterfeit versions of drugs like Lipitor, Viagra, and Evista, which can be quite dangerous, are readily available in border towns like Juarez, Los Algodones, Nogales, and Tijuana.
The FDA has been working with Mexican authorities to address this problem throughout Mexico and, as a result, 19 pharmacies have been suspended and over 105 tons of medicines have been confiscated. Counterfeiting is known to be taking place in China and Russia.
Recently, five heart patients in Hamilton, Ontario, Canada may have died after taking fake medication dispensed from the same pharmacy. The drug in question, Norvasc, is used to treat unstable angina and high blood pressure.
An investigation prompted by a local woman who was suspicious of an oddly colored pill in her supply of Norvasc. The pill turned out to be made of talcum powder.
The Medicines and Healthcare Products Regulatory Agency (MHRA), which is the UK equivalent of the FDA, in conjunction with Pfizer, recently 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.