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
CanadaDrugs.com, 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 CanadaDrugs.com, 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.
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 CanadaDrugs.com, 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.
Read the remainder of the article here
The warning letter to CanadaDrugs.com
The letter to Arkadiy Kisin/White Forest Solutions
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