FDA alerts on fake cancer drug imports

By Dr. Ananya Mandal, MDApr 5 2012

This week, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals that 120 vials of fake cancer drug Altuzan - which contained no active ingredient - had entered the U.S from distributors in the U.K. after being purchased from wholesalers in Turkey.

Connie Jung, who is with the FDA's Office of Drug Security, Integrity and Recalls, said, “What we're seeing is a pattern of this risky practice of purchasing unapproved drugs from foreign suppliers.” Altuzan has the same active ingredient as the cancer-fighting Avastin, but is sold only in Turkey and not approved for use in the United States.

According to British authorities, 82 of the counterfeit vials were shipped to the U.S. by River East Supplies, located in the U.K. and owned by Canadian businessman Tom Haughton. Haughton is currently under federal investigation for shipping counterfeit Avastin into the U.S., offering Avastin for about $2,000 a vial - some $400 less than the manufacturer's price. The FDA said one distributor of the fake Altuzan was California-based Ban Dune Marketing. In February, its owner pleaded guilty to distributing “adulterated prescription drugs” used for cancer treatment and not approved by the FDA. According to the government, it offered big discounts on cancer treatment drugs – “14 to 60 percent” - requesting doctors keep its price list confidential.

Doctors bought the counterfeits through Richards Pharma, a United Kingdom-licensed distributor that also does business as Richards Services, Warwick Healthcare Solutions and Ban Dune Marketing Inc.

Avastin is used to treat cancers of the colon, lung, kidney and brain. No deaths have been reported in connection with the counterfeits. The agency says any packages or vials labelled with the lot number B6021 should be considered counterfeit. The agency is advising doctors to stop using any drugs acquired from the network. No deaths have been reported in connection with the counterfeits.

In February the FDA announced an investigation into a different batch of fake Avastin distributed to doctors in several states. Those counterfeits appeared to have moved through a different network of distributors. European regulators traced the packages through Britain, Denmark, Switzerland and the Middle East. The original country of origin remains unclear.

Roche sells Avastin in 120 countries and manufactures and packages the drug at eight sites worldwide. The company is headquartered in Switzerland. A spokeswoman for Roche’s Genentech unit said authentic Altuzan packaging has text in Turkish, while the counterfeit packages obtained by the FDA have English text. She added that importing even authentic Altuzan into the U.S. is illegal. “The only Avastin that can be legally purchased by wholesalers in the United States is FDA-approved Avastin manufactured by Genentech,” said Charlotte Arnold, in a statement.