FDA Finds More Counterfeit Cancer Drugs

The U.S. Food & Drug Administration (FDA) has found more counterfeit cancer drugs, it said. A prior international counterfeit Avastin investigation spanned from California, to Turkey, to Egypt.

This new scam also involves a batch of counterfeit Avastin—a cancer medication manufactured by Roche—that was discovered in the United States, purchased in Turkey, and shipped through Britain by a U.K.-based firm, according to officials today, said Reuters. The shipment pattern is similar to the prior case; however, the middlemen involved are different, noted Reuters.

As with the prior case, the fake Avastin does not contain the key ingredient in Avastin, bevacizumab, which is prescribed for the treatment of colon, lung, kidney, and brain cancers, the FDA confirmed to Reuters.

The repeat crime serves to further draw attention to weaknesses in the worldwide medical supply chain, which leaves patients vulnerable to ineffective or tainted drugs.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) is investigating how this new batch of Avastin made its way into Britain before it was sold in the U.S. “It’s an ongoing investigation,” spokeswoman Jennifer Kyne told Reuters. “We’re helping the FDA (Food and Drug Administration) with their investigation and doing all we can on our side,” she added.

In this case, a British wholesaler bought 120 packs of Avastin from a supplier in Turkey; 38 packs were exported to the United States, with the remainder sold to a different British firm and for the purpose of exporting the to the U.S., Kyne explained to Reuters. It does not appear as if the counterfeit Avastin made it to Britain.

The Avastin issue is of concern because, said Reuters, up to now, counterfeiters have focused on simple pills. Avastin a complex injectable biotech medication is different from what has previously been seen.

The fake Avastin was labeled as Altuzan, the Avastin brand sold in Turkey. The FDA advised the MHRA on March 28 that Altuzan batch B6021 was counterfeit, said Kyne. A spokesman for Roche confirmed that authentic Altuzan bears only Turkish-language packaging; however, images of the fake medicine posted by the FDA on its website revealed English-language packaging, said Reuters.

According to the FDA, U.S. medical practices purchased the recent fake Avastin from overseas suppliers, namely “Richards Pharma.” The MHRA said it was following up on all lines of inquiry, including Richard’s Pharma Ltd, based in Warwick, central England, said Reuters. In both cases, the supply source was Turkey. The wholesalers were different, however, with the prior network involving middlemen in Egypt, Switzerland, Denmark and Britain, according to Reuters.

In the prior case, the bogus medication was sold in the U.S. by Montana Healthcare Solutions and Tennessee-based Volunteer Distribution, which are under investigation by the FDA. The FDA said 19 oncology practices might have purchased counterfeit Avastin. “The counterfeiters are so good at what they do, and they’re so good at making a product that looks real, it’s easy for someone to say, ‘well, I didn’t know, it looked right,’” said Ilisa Bernstein, an FDA official.

A source at one of the practices said the Montana Healthcare sales rep was “a good con man…. He had a legitimate business license and he had a legitimate distributor’s license, or it seemed he did,” said the source, wrote Reuters previously.

The source at one of the practices said it bought drugs from Montana Healthcare’s list of U.S. products, not from its “lower-priced European alternatives,” which included Avastin under its Turkish brand name. The source did acknowledge that the presence of these drugs should have alerted the practice that Montana Healthcare was breaking U.S. laws.

This entry was posted in Avastin, Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.