Anti-malarials are some of the most frequently counterfeited drugs on the planet. Yesterday, chloroquine was a relatively-obscure anti-malarial, at least within our own borders. Today, it’s front and center in the fight against coronavirus (COVID-19).  This overnight transformation is a double-edged public health sword.

While hopes are raised for a swift conclusion to this pandemic, the counterfeit threat has also increased exponentially. A Google search for “counterfeit chloroquine” provides ample support for this chilling observation.  Adding to this mix, chloroquine and hydroxychloroquine are both recent additions to the ASHP drug shortages database.  All of this spells trouble for FDA and patients alike. In essence, a perfect storm is forming and opportunistic counterfeiters are certainly paying close attention to these developments.  I suspect, their clandestine facilities are already in overdrive.

Chloroquine’s status as a widely-counterfeited drug, the astronomical spike in demand that is sure to follow, and the current shortage of chloroquine, should send shivers up FDA’s collective spine.  Hopefully, FDA is keenly aware of these factors and is thoughtfully considering effective countermeasures that will secure the chloroquine supply chain and protect vulnerable patients from potential counterfeits.

The agency’s handheld counterfeit detection device (CD-3) may have a vital role to play. I suspect the agency will also need to assign more resources to our nation’s International Mail Facilities (IMFs) where counterfeit shipments of chloroquine are probably already arriving.  The potential impact of corrupt secondary wholesalers must not be discounted either. These supply chain offenders were implicated in the counterfeit Avastin and Altuzan incidents that began in early 2012 and continue to run amok today.

FDA clearly had its hands full before yesterday’s chloroquine announcement, but now it has even more to consider. However, I’m confident the agency is up to the task, especially since the stakes have never been higher.