Three pharmacists from Western Pennsylvania allegedly purchased wholesale quantities of illegal foreign-sourced drugs from an illegitimate Canadian supplier, and while we don’t yet know which pharmacies or drugs are involved, you can be certain more criminal charges and information detailing the insidious nature of this scheme will follow.  According to the DOJ press release, the Canadian supplier (Quantum Solutions, SRL), “purchased prescription drugs made for foreign markets and sold wholesale quantities to three pharmacists in Western Pennsylvania. Quantum purchased the drugs from suppliers located in Turkey, Great Britain and other countries.”

This most recent warning sign demonstrates once again the dangers of regulatory vacuums and how they become the pharma supply chain criminal’s best friend. The NECC compounding catastrophe is a somber example of what can happen when regulators fail to make a stand.  Certainly, they faced a lot of challenges attempting to reign in the growth of compounding abuses that seemed to be spiraling out of control in the decade leading up to that tragic event, but the path to protecting vulnerable patients is not always a straight one. Sometimes it takes decisive action and a steely resolve in the face of obstacles to get the job done.  It’s not always an easy task, but FDA has proven it can do just that (i.e. the agency’s stellar cargo-theft strategy)!

“Analysis-paralysis,” as my former OCI colleague described it, benefits no one but the schemer, the criminal.  So, the million-dollar question then becomes- how many more diversion, counterfeiting, or illegal foreign-sourced drug cases involving wholesalers and pharmacies will it take before state and federal regulators begin to make a stand for patients?  Will it take the equivalent of an NECC-style catastrophe to get their full attention? I certainly hope not, but I fear that is the unfortunate destination to which we are headed.

The next supply chain catastrophe will likely involve a pharmacy, simply because their sheer numbers continue to overwhelm sparse state resources.  If that should happen, and I hope I’m wrong here, it should come as a surprise to no one.   I guess you can say it will be the next supply chain shoe to drop.  Bold FDA leadership, however, can be a difference maker, but that needs to happen soon. As the NECC incident showed-timing in this realm is everything.