FDA Discovers Yet Another Batch of Fake Avastin

FDA Discovers Yet Another Batch of Fake Avastin

April 4th, 2012 // 1:21 pm @

Source: Pharmalot

Like a game of whack-a-mole, the FDA is finding counterfeit Avastin continues to pop up. And the latest batch appears to have been distributed by a different group of suppliers that were identified when the agency first publicized the problem two months ago, according to a safety alert that was issued late yesterday.

The newest round of counterfeits were discovered in boxes that were labeled as Altuzan, which is the actually the brand name for Avastin in Turkey, and also listed Roche, which manufactures the cancer med. The FDA says lab tests confirmed the fake batch did not contain any active ingredient (here is the FDA Medwatch report).

When the news about counterfeit Avastin first surfaced, the distributors cited were based in the US and Canada, but their own suppliers were later traced to other countries, including the UK, Barbados, Denmark, Switzerland and Egypt. And the supply was labeled with writing in French (back story).

Yesterday, the FDA says the newly uncovered counterfeit Avastin was distributed by Richards Pharma, which is also known as Richards Services, Warwick Healthcare Solutions or Ban Dune Marketing. There is a Richards Pharma based in a town called Warwick in the UK and apparently operates other companies that sell pharmaceuticals and healthcare products (see this).

Two months ago, James Newcomb, who ran Ban Dune Marketing, pleaded guilty to one felony count of conspiring to distribute adulterated prescription drugs to as many as 60 US physicians between 2008 and 2011. The drugs came from overseas suppliers in Canada the UK. The drugs involved were Herceptin, Neuopogen and Rituxan, according to the feds.

Newcomb and others, including another Ban Dune employee named Sandra Behe, reportedly began distributing cancer that had specific storage and handling requirements, failed to do so, rendering some shipments into a “gooey mess.” He faces more than three years in prison and must forfeit $1.4 million and a Land Rover seized during an investigation. He will be sentenced next month

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