Operation Pangea X has received a lot of attention in the media, and rightly so. Not only does this collaborative effort demonstrate a global resolve to protect patients everywhere from the insidious flow of counterfeit drugs and other illegal medical products purchased over the Internet, it pays enormous dividends when supply chain incursions like the 2012 counterfeit Avastin incident take place. One of Pangea’s greatest features is establishing relationships that would not have existed otherwise. The ability to call or email Pangea-forged law enforcement or regulatory counterparts across the globe when a counterfeit drug event breaks is an invaluable by-product of this decade-long operation. Although one could argue Pangea is a whack-a-mole approach to an ever-expanding Internet drug problem, anything less would signal defeat to criminals, incite more illegal activity in this sector, and spell doom for the vulnerable patients such schemes seek to exploit. Pangea is certainly here to stay and its significance will only increase over time.
While FDA’s commitment to Pangea is commendable, I have often wondered why the agency has shied away from a similar approach to address the well-documented presence of counterfeit and diverted drugs in our legitimate pharmaceutical distribution supply chain. This regulatory imbalance is perplexing. Patients who receive their prescription drugs from hospitals, medical clinics, and pharmacies expect and deserve the same level of attention from FDA as those who utilize online pharmacies, but that has not been the case. An intensive week-long FDA operation focused on supply chain security is long overdue.
For instance, FDA could spearhead an operation to detect possible drug diversion and counterfeiting schemes in collaboration with its state regulatory counterparts, while the agency’s Office of Criminal Investigations could partner with the Department of Justice and its Consumer Protection Branch when criminal investigations and prosecutions are appropriate. Perhaps FDA could even roll out its groundbreaking CD-3 technology during such an operation.
For one week a year, FDA directs substantial resources to combatting the global online pharmacy scourge in connection with Operation Pangea. Unless FDA adopts a similar approach to our nation’s woefully-underregulated legitimate pharmaceutical distribution supply chain, vulnerable patients will continue to fall prey to undeterred criminals whose drug diversion and counterfeiting schemes are placing the public health and safety on a very dangerous trajectory.