Tag Archives: crimes

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Superhero right to leftLast week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now.  Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.

In this Part 2 essay I want to look at the issue in a different way.  I’d like to compare the approach that Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals

Studying the IOM reportI’ve been reading the Institute of Medicine (IOM) report called “Countering the Problem of Falsified and Substandard Drugs” that was published last week.  At 360 pages, it is quite literally a book, and you can buy it that way.  But they also allow you to download the “Pre-publication Copy:  Uncorrected Proofs” version in a 300 page PDF for free.  I’m not sure why they would post uncorrected proofs rather than the final document on their site but I assume the text is in its final edited form and only the formatting might be different between the book and the PDF.  I hope so anyway.

I have not yet read the whole thing so this isn’t intended to be a proper review (see the Regulatory Focus article about it).  The document offers Continue reading Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals

How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

Cumberland DistributionOn January 17, 2013 a federal grand jury indicted three individuals in 28 counts connected with Cumberland Distribution, a pharmaceutical distribution company licensed in Tennessee, on charges of conspiracy, mail fraud, money laundering and obstruction of justice.  Notably, some of the evidence used against the alleged co-conspirators are the pedigrees that they allegedly forged in an attempt to make their business look legitimate to their unsuspecting customers.

Now, as the press release about the indictment from the U.S. Department of Justice (DoJ), Middle District of Tennessee points out, “An indictment is merely an accusation and is not evidence of guilt.  All defendants are presumed innocent unless and until proven guilty in a court of law.”  So let’s just look at the evidence and how the DoJ is using it to build their case against the defendants in this case.  From that we can see what impact pedigrees might have in other cases like this.

The charges are for activities that Continue reading How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

The Built-in Protections Of The U.S. Pharma Supply Chain

Last week we learned that 11 people were charged with the record-breaking $75 Million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010 (see the excellent article by Jay Weaver in the Miami Herald, including a copy of one of the multiple indictments).  Importantly, all of the stolen drugs from the Lilly warehouse were apparently recovered before they could be re-introduced into the legitimate supply chain.  But this investigation and the charges go well beyond the infamous Lilly warehouse theft.  They include other pharmaceutical, liquor, cigarette and cell phone cargo thefts around the country, allegedly perpetrated by members of the same criminal organization.  Cracking this organization could end up disrupting the most prolific source of cargo theft in the United States over the last five years.

Congratulations are due to the law enforcement organizations who contributed to the investigation and to bringing the charges.  They include DEA, ATF, FBI, U.S. Attorney of Florida, Miami-Dade Police Department, Florida Highway Patrol, U.S. Attorney of Illinois and U.S. Attorney of New Jersey.

This episode highlights one of the things I call the built-in protections of the U.S. pharmaceutical supply chain—the things that, combined, result in the U.S. having the safest supply chain in the world.  In this case, it is strong and cooperative law enforcement organizations.  While far from perfect, would you trade our system of justice, including law enforcement, with that of any other country in the world?  I don’t think you would (unless you’re one of the Villa brothers or their associates!).

But what are the other components that result in the safest drug supply chain in the world?  It’s certainly doesn’t occur by accident, so what are the built-in protections? Continue reading The Built-in Protections Of The U.S. Pharma Supply Chain

Dangerous Doses

If you have chosen to read this blog but you still haven’t read Dangerous Doses by Katherine Eban, you have made the wrong choice. The book is a great read. It documents the events in the early 2000’s that led the State of Florida to pass the first state pedigree law in 2003. You can draw a straight line between those events and all of the state pedigree laws that came after it. The book is a detailed accounting of crimes that occurred after a few criminals realized that law enforcement and the courts would not take seriously any drug crime that did not involve illegal drugs. But a small group of detectives and a lone prosecutor took them on and eventually brought them to justice. The book alternates between narratives of the crimes, the pursuit of the criminals by the detectives, and Eban’s explanation of how the pharmaceutical supply chain worked back at that time.

But that’s just it. The book was written at a time when things were different than they are now in some very important ways. As I understand it, back then, you could have spent less money on a license to distribute pharmaceuticals than you would if you obtained a license to open a bar. As a consequence, there were thousands of drug wholesalers licensed in Florida. But in 2003 the state toughened its licensing laws, greatly increased the cost of the licenses and increased the penalties for crimes related to wholesale distribution of pharmaceuticals. The HDMA cataloged the significant changes to Florida’s drug distribution regulations as the result of those changes. The number of licensed wholesalers plummeted to only a few hundred in the following years.

Oh, and they passed a pedigree requirement too.

I have to admit that I don’t have a good window into what exactly is going on in the Florida crime scene today but given the heightened awareness in the press of counterfeiting and diversion stories, I have to think that there is not nearly the problem that there was back in 2002, or we would hear about it.

So that pedigree requirement really worked, right? Maybe, but I have to think that the increased licensing fees and other requirements, the increased penalties and the increased interest by the courts are the things that really caused criminals to think twice about getting into that business.

Dangerous Doses is a great book and I still highly recommend it to anyone, especially those like me, who are responsible for working on pedigree, serialization and track & trace systems for companies in the supply chain. But as you read it try to keep in mind, that era doesn’t exist anymore. Since that time many other states have taken comparable steps to strengthen their licensing and toughen penalties. And many of them have also passed some type of pedigree law. Stay tuned for more about some of those laws in later posts.

Do drugs still get counterfeited and sold in the U.S.? Probably, but the criminal activity seems to have moved from the supply chain to the internet where criminals can hide just across the borders. Check your spam folder for the evidence.