Saturday 4 January 2014

FDA shoots warning across bow of

FDA shoots warning across bow of

The FDA has sent a warning letter to one of the most prolific Internet drug providers from Canada, which reports have tied to an investigation of counterfeits of the cancer drug Avastin that were sold to physician practices in the U.S. this year.The agency this week posted a warning letter sent to a lawyer in Manitoba claiming that hundreds of websites it identified, including, were offering for sale drugs made at unapproved facilities. It said the sites were even offering domperidone, which it said is no longer approved for sale in the U.S. because of dangers to breastfeeding women. 
A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010. 
An investigation this year by The Wall Street Journal tied the owner of, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.The FDA in February and April discovered the counterfeit cancer drugs. Some of the recovered boxes were labeled Altuzan, which is the brand name for Avastin in Turkey. Tests, however, determined that there was no active ingredient in the counterfeits. So far, there have been no reports of problems related to the drugs, according to the FDA and Genentech, the Roche ($RHHBY) unit that makes the cancer treatment.The letter came only days after the agency launched a new campaign it hopes will discourage the practice of buying drugs online, or at least, teach consumers how to determine what sites are potentially legit. The agency last week launched BeSafeRx, to warn against the dangers.- here's the warning letter to
- here's the letter to Arkadiy Kisin/White Forest SolutionsRelated Articles:
Fake of Roche's Avastin shipped from Canadian supplier
Phony Avastin vials contained chemicals, but no drugs
Avastin alert likely to revive discussion of pharma-financed tracking system
U.S. market size, shortages lead to more counterfeits
FDA tries to teach consumers of Internet dangers read more..


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