It’s been more than four years since the counterfeit Avastin and Altuzan incidents first came to light. Since that time, we’ve also learned of three mammoth prescription drug diversion cases totaling close to $1.5 billion in fraudulent drug sales. Yet, it appears that securing our nation’s pharmaceutical distribution supply chain remains a relatively low priority among FDA and state regulatory authorities. How can this be? Future supply chain incursions on par with these diversion and counterfeiting events, or worse, are sure to be lurking just around the corner. It’s pure folly to think otherwise considering the exponential growth of the problem over the last decade.
When lives are potentially at stake, the public expects FDA to act with a sense of urgency. That is the big take-away from the New England Compounding Center (NECC) catastrophe of 2012. Unfortunately, I get the sinking feeling that FDA is approaching our nation’s increasingly vulnerable supply chain the same way it handled the rise of compounding abuses in the years leading up to the NECC disaster. For instance, FDA’s December 2012 meeting with the states took place three months after the NECC catastrophe and confirmed something the agency should have known years before-that states needed FDA’s help to reign in out-of-control interstate compounding along the lines of NECC. Why then did FDA wait until after the catastrophe to convene this meeting? Is that same pre-NECC mindset affecting FDA’s strategy on supply chain security issues?
Hopefully, my concern is unfounded and FDA leadership is resolved to pursuing supply chain security initiatives with a newfound sense of urgency and vigor. With that in mind, some potential initiatives that FDA may want to consider are provided below:
Timely collaboration with applicable state regulatory authorities to assess the adequacy of wholesale distributor and pharmacy oversight on supply chain security issues and the development of novel solutions designed to mitigate any major regulatory gaps that are identified;
An FDA letter to stakeholders about the prevalence of wholesale distributors in the agency’s public database that are licensed as or affiliated with pharmacies and which addresses how such relationships are fueling the continued diversion of shortage drugs and drugs intended for certain patient populations that are subject to special pricing provisions;
Revised agency guidance on suspect product identification that encourages product tracing validation efforts before, not after, suspect product determinations are made and which explains in detail how this process can be accomplished in coordination with trading partners to further secure the supply chain;
Regular FDA analysis of the number and types of illegitimate product notifications the agency has received since January 1, 2015 to aid trading partners in refining supply chain security programs;
FDA definitions of “diverted drug” and “fraudulent transaction” to remove the veil of willful blindness that is exploited by corrupt trading partners intent on avoiding suspect product determinations and which will greatly assist the efforts of legitimate trading partners committed to identifying suspect products with greater frequency;
Agency enforcement actions targeting wholesale distributors that have not yet reported to FDA in violation of the FD&C Act.
I understand more than most the extreme challenges FDA is facing as it attempts to implement the multi-faceted Drug Supply Chain Security Act with limited resources, but these highly achievable initiatives have the potential to dramatically enhance supply chain security and patient safety and can be accomplished without significant impacts on current resource levels.