Once again, the feds have unfurled a massive prescription drug diversion case highlighting the indispensable role of bogus transaction histories (or pedigrees prior to 2013) in perpetrating these all-too-frequent criminal schemes.  A similar case was announced just last month.

According to an October 18th DOJ press release, “Joshua Ryan Joles, the CEO of LLC Wholesale Supply, LLC, Mohammad Mehdi Salemi, the CEO of Wholesalers Group, Inc. and Wholesalers Group, LLC, and bank account holders Angel Caminero Alvarez and Leonides Herrera were indicted on charges of money laundering, committing violations of the Federal Food, Drug, and Cosmetic Act, and mail fraud, related to their alleged participation in a scheme to sell diverted pharmaceuticals to unwitting pharmacies and consumers.”

DOJ referenced the corresponding indictment which alleged that Joles and Salemi “purchased and distributed millions of dollars in diverted pharmaceuticals, which are prescription drugs illegally trafficked in a secondary or underground market.” DOJ added, “The indictment explains that the diverted pharmaceuticals are not controlled substances, but rather, high priced medical drugs used to treat such conditions as mental illness, human immunodeficiency virus (HIV), and cancer.  They are branded drugs, produced by the original pharmaceutical developers as opposed to lower-priced generic drugs, but are acquired unlawfully — through fraud, pharmacy burglaries, and cargo thefts.”

In addition, it was alleged that Joles and Salemi “produced or caused the production of fraudulent paperwork, including falsified pedigrees, which are documents that identify the products and batch numbers of pharmaceuticals, describe their dates of manufacture and origin, indicate who purchased them, show when and where they were shipped, how they were purchased, and other information needed to trace them through the marketing chain.”

“Utilizing these false pedigrees, Joles and Salemi allegedly sold or caused the sale of these diverted pharmaceuticals to unsuspecting pharmacies and their patients,” DOJ added.

Interestingly, LLC Wholesale Supply was implicated in another massive drug diversion case in 2012 that also involved false pedigrees.  Should FDA have had this drug distributor on its radar ever since? Perhaps so. Whether they did or not is something only the agency can address.

It is an indisputable fact that criminals masquerading as legitimate secondary wholesale distributors rely on these sham records to sell their fraudulently-obtained medications to complicit, willfully-blind, or just plain careless independent pharmacy customers.  This scenario has been a common thread in almost every major drug diversion case over the last few decades, but for some unexplained reason it continues to be overlooked by FDA. I’m convinced this thread is the key to unravelling the pernicious and longstanding threat to patient safety from corrupt drug wholesalers, but FDA first has to pull it to find out. I hope this happens sooner rather than later because I’m running out of new ways to write about the same old issue.