October 2, 2012 | By
Eric
Palmer
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.
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