How many criminal drug supply chain cases will it take before FDA recognizes that state wholesale distributor and pharmacy licensing programs are failing to protect patients from drug diversion and counterfeiting schemes?  The fact is, patients are no safer under the DSCSA than they were under the PDMA.  I’m not aware of any data that supports a different conclusion.  Resource and leadership inadequacies that led to the demise of the PDMA have not improved in any meaningful way since the DSCSA was enacted more than five years ago. The regulatory landscape is not going to magically shift.  There is no resource or leadership genie.  Something has to dramatically change or patient safety will continue to erode, just as it has over the last few decades.

Just yesterday, The Brunswick News reported that a Florida doctor and his wholesale drug distribution business in Georgia were indicted by a federal grand jury on an array of criminal charges related to smuggling and selling counterfeit Viagra. The indictment reportedly charged Dr. Hugo Romeu with buying counterfeit Viagra from Hong Kong that was “falsely declared for customs purposes” and selling it to American customers through his wholesale operation, Pharmrce USA.

A doctor-owned drug distribution facility dealing in counterfeit Viagra is hard to fathom.  But we should not be too surprised considering the litany of drug diversion and counterfeiting cases involving pharmacists.  The presence of corrupt doctors and pharmacists in our drug supply chain is a troublesome harbinger that the DSCSA is headed for the same fate as the PDMA unless novel approaches are undertaken in earnest by all stakeholders.

FDA’s CD-3 could be the answer.  This counterfeit detection device has the potential to tilt the scales back in favor of patient safety.  For instance, CD-3 could be employed in droves by Pharmacy Benefit Managers to detect and deter drug diversion and counterfeiting schemes during hi-risk independent pharmacy audits.  State pharmacy boards and their counterparts could add CD-3 to their arsenals when inspecting hi-risk secondary wholesale distribution facilities.  Non-profits could also utilize CD-3 to ensure drug safety and legitimacy for HIV and hemophiliac patients whose drugs have been historical targets of drug diversion schemes.  CD-3 could also be used in hospitals and medical clinics throughout the country to detect and deter controlled substance tampering incidents before the dangerous products are ever administered to patients.  It’s also conceivable that widespread CD-3 implementation could have a positive impact on our nation’s spiraling health care expenditures as drug supply chain frauds dwindle.

CD-3 technology offers many exciting opportunities within the drug supply chain and I’m confident that its time has finally come. Without such novel approaches, it can be expected that supply chain incursions and fraudulent activity will only increase in scope and frequency.