If you happen to take a stroll around FDA’s White Oak campus next week, you will see something unusual-few people and lots of empty parking spaces. Federal buildings resemble ghost towns this time of year as throngs of employees throughout government power down their computers until after the New Year. A major consolation for the skeleton crews that remain is a more relaxed work-pace until the end of the year. Which brings me to the real reason behind this post. I started to suspect, given the traditional late December slow-down, that FDA was going to fall short on meeting its self-imposed December 2016 deadline for establishing regulations for national wholesale distributor licensing standards. And I was right. Under the DSCSA, FDA was mandated to issue these regulations by November 27, 2015, but Office of Management and Budget (OMB) notices referenced actual agency timetables of December 2016 and then June 2017.
FDA likely has legitimate reasons for delaying this and other key DSCSA deliverables, but that does little to quell my unease about the status of our nation’s increasingly vulnerable pharmaceutical distribution supply chain. The unintended and troubling byproduct of this latest delay is to further embolden diverters and counterfeiters who may view FDA’s somewhat lackluster approach to meeting its DSCSA mandates as a green light to continue business as usual. As a result, it can be expected that legions of supply chain pillagers, undeterred by the current regulatory landscape, will continue to thrive. The stakes for patients couldn’t be any higher. A sea change is urgently needed to protect patients from the ever-increasing threat of diverted and counterfeit drugs. I’m hopeful that 2017 is the year when such a shift begins to unfold in earnest!