In one of the first criminal convictions of its type, two companies pled guilty for failing to provide pedigrees. Can you guess the year? No, it wasn’t 1988, the year President Reagan signed the PDMA into law. Not even 1998, a decade later. If you guessed 2004, a whopping 16 years after the PDMA became law, take a bow, you are correct. According to FDA’s Enforcement Story (see p. 40), two Ohio-based wholesale distributors, RxBazaar, Inc. and its wholly owned subsidiary, FPP Distribution, Inc., pled guilty in August 2004 to one misdemeanor charge under the FD&C Act and were each sentenced to five years of probation and fined $100,000. This case marked “a significant step in assuring that prescription drug wholesalers fully conform with laws that ensure the integrity of the nation’s drug supply,” FDA added. While this case was certainly a “significant step,” albeit one that was long-overdue, it was likely the last of its kind, a dinosaur. However, things changed dramatically in early 2012. The counterfeit Avastin and Altuzan incidents demonstrated that such criminal cases, once viewed as low priorities, could no longer be neglected.
So, it’s no stretch to say the June 2015 DSCSA-related cases I previously wrote about are a big deal. This time, it took less than two years for similar charges to be filed against three individuals for failing to comply with the DSCSA’s new product tracing provisions. Hopefully, these cases are emblematic of a steadfast resolve within FDA to aggressively target prescription drug diverters and their criminal cohorts which threaten our nation’s pharmaceutical distribution supply chain on a daily basis. Apollo Creed’s impassioned plea to Rocky in Rocky III sums it up-“THERE IS NO TOMORROW!”
Over the last 10 years prescription drug diversion has grown exponentially. The Albers Medical case of 2005, a landmark supply chain event, involved a $42 million dollar conspiracy to distribute counterfeit Lipitor, as well as smuggled foreign versions of Lipitor and Celebrex, and led to the recall of more than 18 million Lipitor tablets. The impact of this case was unprecedented. Fast forward to May 2015 when a mammoth case involving nearly $400 million in diverted drugs was announced. Judged solely by the dollar amount of these two cases, the problem has grown ten-fold over the last decade, but regulatory and law enforcement agencies have failed to keep pace with this alarming trend. The fate of our nation’s vulnerable patients hangs in the balance as long as such authorities fail to grasp the scope and urgency of the current problem. I’m hoping, like Rocky, they will ultimately rise to the challenge.