What is a counterfeiter to do today? Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line. It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities. Or is it? Let’s take a closer look.Continue reading Pharma Counterfeiter Strategies In a Track & Trace World
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 Continue reading InBrief: Illegally Imported Drugs Found To Be Counterfeit…Again
It’s hard to imagine why people would actually prefer to buy drugs from internet websites that are obviously not licensed legitimate pharmacies. That is, those that do not require proof of a valid prescription from a legitimate prescriber, and/or do not carry an online pharmacy certification (especially from the National Association of Boards of Pharmacy, NAPB, VIIPS program). In an earlier essay I said this about people who would buy drugs from these illegitimate sources:
“Most of the criminal activity has moved out of the legitimate supply chain, mostly onto the internet. You know, the internet, where criminals can sell drugs directly to the few consumers who are dumb enough to think that someone will sell them legitimate prescription drugs, but do so illegally by not requiring a prescription. That is, they think that some faceless company would be willing to knowingly break one law, but could then be trusted to provide real pharmaceuticals at below market prices. In the age of the internet, how do you protect people who are that gullible?”
A few weeks after writing that rather disparaging passage I met one of those gullible people Continue reading Some People Actually WANT To Buy Counterfeit Drugs
The internet lit up last week when the U.S. Food and Drug Administration (FDA) posted an announcement that they are aware of counterfeit Avastin in the U.S. pharmaceutical supply chain (see “Counterfeit Version of Avastin in U.S. Distribution” on the FDA website and Genentech’s announcement).
I found out about it when I received notice of Dr. Adam Fein’s (PhD) excellent blog posting “Greedy Physicians Invite Fake Avastin Into the Supply Chain” on his DrugChannels.net blog, but multiple national news agencies picked the story up and many articles were written about it. Most simply reflected the contents in the FDA’s announcement.
But at least one news source seemed to do some additional investigating. Bill Berkrot and John Acher of Reuters published the excellent article “Fake Avastin’s path to U.S. traced to Egypt” on Thursday. In the article they provide a little more background on the path the drugs allegedly took before apparently arriving on the shelves of U.S. physicians and potentially in the bodies of unsuspecting U.S. patients.
And Pharmaceutical Commerce Online reports that Avastin isn’t the only incident of recent counterfeit injectable cancer drugs making it into the U.S. market that the FDA is currently investigating.
HOW COUNTERFEIT AVASTIN MADE IT INTO THE LEGITIMATE U.S. SUPPLY CHAIN
Now keep in mind, this is only investigative journalism so far, and while the information source listed in the Reuters article is the Danish Medicines Agency, criminal investigators may already know more than this and in the end, some or all of the contents of the Reuters article may eventually be found to be untrue. Whether ultimately true or not Continue reading How Counterfeit Avastin Penetrated the U.S. Supply Chain
There was a flurry of discussion last week over a recent Wall Street Journal blog by their “Numbers Guy”, Carl Bialik, regarding the often quoted “estimate” that 10% of drugs worldwide are counterfeit. On September 10, Bialik posted an essay titled, “Dubious Origins for Drugs, and Stats About Them“. The next day he published an article on the topic called “Counterfeit Drug Count Is Tough to Swallow“. Both essays call into question the origins and the accuracy of the “estimate”. On September 13, Dr. Adam Fein posted an essay titled, “The Counterfeit Counterfeit Drug Count” on his DrugChannels blog, citing the WSJ essays and providing some additional insight.
Don’t miss the many comments left by readers of Bialik and Fein’s postings. It’s surprising how Continue reading Stop Claiming that 10% of Drugs Worldwide are Counterfeit