Fighting the onslaught of counterfeit drugs in the U.S. seems to be a fight against the online pharmacies responsible for selling them. Much of the news and many of the high-profile cases have centered on this pathway for fakes to make their way into the hands of U.S. consumers.
There was the arrest of Andrew Strempler, the former owner of a Canadian Internet pharmacy that an indictment alleges sold counterfeit and unapproved drugs to U.S. citizens. There was the recent Interpol crackdown on illegal pharmacy websites globally, an effort to try strike at some of the operators and to put on notice the hosting companies they rely on.
In fact, anti-drug counterfeiting efforts in the U.S. are a race against death. It is a sprint to get into place more enforcement and more protections before that first inevitable case when someone dies from taking a counterfeit, either because it kills them directly or because the pseudo treatment fails to keep them well.
As this reports points out, the appearance of counterfeit Avastin and other cancer drugs in the U.S. earlier this year raised the stakes enormously. It was the wakeup call that counterfeiting was no longer relegated to fakes of just so-called lifestyle drugs like Viagra and Cialis.
When it does happen, when that first case of death or serious harm hits the public consciousness, there will be a huge public outcry that will light a fire under politicians to act. If there are not already sensible programs and precautions under way, there is no way of knowing what direction that kind of legislative knee-jerk response will propel regulators and the industry.
There will be questions about why the track-and-trace program the FDA supported got killed in backroom political deal-making and there will be questions about why we can't do more to regulate products coming in from China or India, believed to be the key sources of counterfeits.
The World Health Organization (WHO) is hardest on developing countries where fakes of treatments for conditions like malaria result in untold and unnecessary deaths. Financially, WHO estimates counterfeiting costs the pharma industry $75 billion a year. With the way the industry has segmented out with cheap labor countries now accounting for an estimated 80% of raw materials for the industry, it makes the regulation and enforcement many times more challenging.
This report points to some of the most significant events in the effort to address counterfeiting to have occurred this year. Maybe you know of others not mentioned. It would be great if the report could start a public discussion of what steps need to be emphasized next because there is little question that more needs to be done and it is best if it is done with some forethought. Click here to check out the full report >> -- Eric Palmer (email |Twitter)