Any law, no matter how well-intentioned or deftly crafted, will ultimately miss its mark without the requisite resources in place to ensure compliance. This is best described by the oft-used speeding analogy. Legislators can require the posting of speed limit signs at conspicuous intervals along the highway, but unless there are enough police officers dedicated to enforcement, most people will nonetheless continue to speed (some more than others, of course). The signs themselves are not the deterrent, it’s the flashing lights and the traffic stops on the side of the road that other passing motorists remember, regardless of whether the officer only issued a verbal warning. This vivid memory gets filed away until the driver next visits that stretch of road, unless he or she happens to be distracted at the time (an all too frequent occurrence nowadays).
It is no different with our nation’s pharmaceutical distribution supply chain, where criminal activity seems to have taken quite a foothold, reaching what certainly appears to be epidemic proportions. The DSCSA is the equivalent of posting speed limit signs along the supply chain highway, but understanding the number of trading partners on the road is key to building a comprehensive and successful DSCSA enforcement strategy. You may only need one or two officers patrolling the roads in Mayberry USA, but hundreds more are needed along our nation’s busiest interstates. You get the point…
With that in mind, consider that FDA estimates there are approximately 69,000 pharmacy sites in the United States, roughly half of which are considered independent or privately owned. Because the overwhelming majority of pharmacy-involved supply chain crimes are attributable to this segment of pharmacies, let’s assume for purposes of this discussion that 30,000 such entities are potentially at risk. FDA also estimates there are about 2,200 small wholesale distributors throughout the country (once established, FDA’s public database of wholesale distributors will provide a concrete number). Since this group of wholesales has almost always been associated with wholesaler-involved supply chain crimes over the last decade, let’s also assume that all 2,200 such entities are potentially at risk. This amounts to roughly 32,200 independent or privately owned pharmacies and small wholesale distributors throughout the country that are potentially susceptible to prescription drug diversion and counterfeiting crimes which the DSCSA alone is unlikely to deter. Broken down by state, this equates to approximately 600 such pharmacies and 44 such wholesale distributors per state.
Juxtaposing these figures against information from the April 2013 Congressional report on the New England Compounding Center catastrophe shows the extent of the resource issue facing state regulators. Congress found, “Even with increasing numbers of pharmacies and general increases in board of pharmacy budgets, on average states employ just 5 inspectors per state (emphasis added), with the most inspectors being utilized in California-30, Ohio-22, Florida-18 and Georgia-14 and the fewest being utilized in Alaska-1, Vermont-1, Hawaii-1, and Wyoming-1.5. These inspectors are responsible for inspecting all pharmacy activities, and based on survey results, the average number of 5 inspectors has stayed fairly consistent over the last decade. In several cases these inspectors are also split between the board of pharmacy and other professional licensed boards and are responsible for inspecting and investigating all such facilities (for example, dental and medical facilities or other drug distribution facilities including wholesalers) that fall under their purview.”
While corralling susceptible wholesale distributors through collaborative federal and state regulatory and law enforcement initiatives is certainly not an insurmountable task, the sheer volume of susceptible pharmacies, however, makes such a proposition involving those entities a far different story. Unfortunately, controlled substance diversion and compounding problems garner the majority of state resources and attention, to the detriment of growing supply chain security concerns and, ultimately, to patient safety as well.
FDA should therefore commit to designing and implementing a susceptible wholesale distributor detection and deterrence strategy in conjunction with its state counterparts as soon as possible. The number of such entities is entirely manageable and does not represent an obstacle. Remember, a police officer does not have to stop every speeder to establish compliance with posted speed limits, just enough to let drivers see the law is regularly being enforced. Likewise, FDA’s strategy does not have to entail a visit to all 2,200 susceptible wholesalers at once. A goal of 10 joint FDA/state risk-based inspections per month is realistic and achievable and would result in an inspection rate of approximately 5 percent each year. While this may appear to be too meager, it won’t take long for the word to get out that there is a cop on the beat, so to speak, and many wholesalers will quietly disappear before they are ever visited by state and FDA inspectors. If FDA can dedicate itself to this task, the number of corrupt wholesale distributors will begin to shrink dramatically and corrupt pharmacies will be forced to clean up their act, go out of business, or obtain diverted drugs directly from unlicensed suppliers, something many semi-legitimate pharmacies will be unwilling to do. All of these possible scenarios represent enormous victories for supply chain security and patient safety, but they cannot be realized without FDA leadership.