Yesterday the FDA alerted healthcare providers that a cancer drug illegally imported and distributed to medical practices by a licensed pharmaceutical distributor going by the names “Medical Device King” and “Pharmalogical”, and Taranis Medical, is counterfeit.  The FDA alert can be found here.  Once again, the drug is labeled as Altuzan, a version of bevacizumab which contains the same active ingredient as Avastin.  Here is AP story about it.  Here is the WSJ article about it.

Avastin was the subject of a counterfeit importation crime about a year ago, (see “How Counterfeit Avastin Penetrated the U.S. Supply Chain“).

It is illegal to import drugs that are not approved by the FDA for sale and use in the U.S., and so even if the drug had not turned out to be a counterfeit version, this would have still been a crime.  It makes me wonder if the reason this case came to light was because the drug name on the package was clearly not approved here.  What if the counterfeit drug had been labeled as plain old approved Avastin with a valid NDC?  Would it have been detected so easily?

The actual counterfeiter in this case was probably not targeting the United States.  Because the Altuzan brand of bevacizumab (made by Roche) is approved for sale and use only in Turkey, that is the country that was probably originally targeted.  It is possible (likely?) that the units that made their way here started out as a case of diversion which turned out to be fulfilled with counterfeit units!  That is, the U.S. importer may have intended to divert real Altuzan from sources in Turkey to the U.S. where they could be sold in place of orders for Avastin at a much higher profit.  The fact that the Altuzan turned out to be counterfeit may have been a case of the source defrauding the criminal importer.

If so, too bad for the importer.  Now that the FDA Safety and Innovation Act (FDASIA) is law, he or she will face significantly increased penalties for endangering patients by distributing counterfeit drugs.

Dirk.