Everywhere I go lately I am asked “Do you think the California ePedigree dates will slip again?”. I don’t have any special or inside knowledge but, as usual, I do have a theory about that. I offer it to you here as one possible outcome. You can decide for yourself if you think it is dubious, merely plausible, fully probable, or somewhere in-between. Continue reading Will The California ePedigree Dates Slip Again?
Two weeks ago, confessed pharma supply chain criminal William Rodriguez of South Florida was sentenced to 10 years of prison time, and then two years of supervised release. He was also required to hand over $55 million, which represents the proceeds from his crimes.
What was his crime? He was the person who ran the licensed wholesale drug distribution company formerly in South Carolina, Ocean Pharmed, that bought the Novo Nordisk insulin that was stolen in a cargo theft back in 2009. In his plea, Rodriguez admitted that all of the drugs that Ocean had sold into the supply chain had been obtained from unlicensed or otherwise illegitimate sources, like the stolen insulin.
This is the story that was so well documented by Katherine Eban in her excellent March 2011 article, “Drug Theft Goes Big” in Fortune Magazine online, and which I discussed in my essay “Lessons from ‘Drug Theft Goes Big’” and further Continue reading InBrief: Pharma Supply Chain Criminals Get Justice
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
There are more than one reasons why you shouldn’t expect to use GS1’s EPCIS by itself to comply with the California pedigree law. Part 1 of this series showed that the traditional distributed network of EPCIS repositories in the U.S. pharma supply chain doesn’t work. But that analysis assumed the use of the “vanilla” EPCIS standard, without the use of any “extensions”. That’s not really the way GS1 intended EPCIS to be used. In this and future essays of this series I will explore some of the approaches that make full use of the extensibility that is built into the standard.
In this Part of the series I want to take a closer look at the work of the Network Centric ePedigree work group of the GS1 Healthcare Traceability group. I am one of the leaders of that group along with Dr. Mark Harrison of the Cambridge University AutoId Lab, Dr. Ken Traub, Independent Consultant, and Gena Morgan of GS1, along with strong contributions from Janice Kite of GS1 and Dr. Dale Moberg of Axway. The larger group consists of people who work for companies in the pharmaceutical supply chain, GS1, and solution providers from around the globe, although I think the majority are from the U.S.
The NCeP group published a very interesting recording of a presentation that explains the details of their work. It is called “NCeP – Technical Analysis Sub-Group, Event Based Pedigree”. The purpose of this recording is to help people outside of the close-knit NCeP group to learn about the pedigree models developed there, evaluate them and provide feedback to the group about which model(s) should be Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2
I attended the Partnership for Safe Medicines (PSM) Interchange 2011 conference on October 27 in Washington DC. (I’ll cover that event more fully in a future essay.) For me, the event couldn’t have been better, but I measure events like this perhaps a little differently than most people. The agenda is important and the quality of the speakers is absolutely important, but in my view those are simply the things that lead to the one thing that can transform a merely good conference into a great conference: the quality of the attendees.
(The quality of the attendees is exactly why I like the HDMA Track and Trace Seminar. BTW, this year’s HDMA event starts this Thursday).
In the case of this year’s PSM event, I rate the quality of the attendees very high, and that’s because I had a number of great conversations with some very knowledgeable people during the breaks and at the social event the evening before. That was my interaction with the attendees, not the speakers. One of the topics of conversation surrounded the question of what exactly it was the led to the successful challenge to the Prescription Drug Marketing Act (PDMA) pedigree provisions in the RxUSA v. HHS court case and appeal and whether or not the same thing might occur with other drug pedigree laws.
AN IMPORTANT QUESTION GOES UNANSWERED
One of the first speakers at the PSM event was U.S. Representative Jim Matheson (D-UT), sponsor of H.R.3026, the “Safeguarding America’s Pharmaceuticals Act of 2011” which was introduced into the House of Representatives on September 22, 2011. There are some differences, but the core of this new bill is basically the same as Continue reading Impact of RxUSA v. HHS On Future Pedigree Legislation
If you are a regular reader of RxTrace but you still haven’t read Fortune Magazine’s recent article, “Drug Theft Goes Big” by Katherine Eban, then I suggest that you stop reading this essay right now and spend the next 15 minutes absorbing her article carefully. And then return here for my analysis. It’s that good and that important.
Many of you will remember Katherine Eban as the author of the excellent book “Dangerous Doses, A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply”. See my comments on the book here where I point out that a lot has changed since the events that are documented so well in the book.
The new Fortune article is a great update on what drug supply chain criminals have been up to since “Dangerous Doses” was published back in 2005. The greatest thing about the article is Continue reading Lessons from “Drug Theft Goes Big”
Understanding the concept of “Normal Distribution” is important in understanding the status of pedigree regulations in the United States pharmaceutical supply chain. The term itself didn’t exist back in the late 1980’s when the federal Prescription Drug Marketing Act (PDMA) pedigree provisions were originally enacted by Congress but the concept is built into that law as the “Authorized Distributor of Record” (ADR) concept. When states began enacting their own pedigree legislation back in the early 2000’s, the term “normal distribution channel” was defined to describe the path of drugs when they move through the most common–or “normal”–sequence of supply chain owners. It’s a concept that is explicitly defined in most state pedigree legislation.
When a pedigree law is a “normal distribution” law, it generally means that pedigrees are not needed for any shipment or change of ownership where the drugs do not leave this common/typical/normal path as defined in the law. But as soon as a change of ownership or custody occurs where the drug leaves this “normal” path, a pedigree is then necessary.
Typically, when a pedigree is required outside the “normal distribution channel”, that pedigree must Continue reading The “Normal Distribution” Concept
I recently read in Pharmaceutical Commerce online magazine about the apparent resolution of the RxUSA lawsuit that had delayed implementaton of a couple of the pedigree provisions of the Federal PDMA (Prescription Drug Marketing Act). While Pharmaceutical Commerce did its usual great job of providing historical context, I thought it might be an appropriate topic for the RxTrace blog. But before I had time to document the history of the PDMA in my own words, Brian Daleiden beat me to it in the Supply Network Blog. So rather than writing my own version, I gladly refer you to his post. Between the Pharmaceutical Commerce article and Brian’s post, I have nothing more to say right now.
The Supply Network Blog is a fairly new publication of TraceLink, the successor to SupplyScape, my former employer. I look forward to hearing more from their blog in the future so I recently subscribed. Check it out and see what you think.
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