Ever since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach. The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).
My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary
Drug verification is at the heart of most pharma serialization regulations. It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not. We can tell a lot about the intent of a given serialization regulation by looking at the specific language that determines by whom and when a unique identifier must be verified. Continue reading Drug Verification: EU Vs US
When serialization of drugs was first being considered for pharmaceuticals back in the mid-2000s, I recall that it seemed to rattle the traditional brand protection vendors who offered package-level authentication technologies. They were more than a little worried that drug companies would end up using serial numbers in place of their more traditional offerings, like holograms, specialty inks, micro-printing and other technologies. Back then, some drug companies were looking at using Radio Frequency IDentification (RFID) tags to carry the serial numbers on their drug packaging, and perhaps these vendors feared that they would be left out.
I never understood what all the angst was about. Continue reading Your Plain Old Package: Unlock Its Built-in Brand Protection Capability
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.:
Continue reading The Future of Healthcare Supply Chain Security
Counterfeiting of drugs has become a favorite activity of organized criminals and it negatively impacts the citizens of every country in the world. The pharma industry is multi-national, the criminals are multi-national, the patients that are harmed are multi-national. What we need now more than ever before is a multi-national approach to fighting these crimes.
That’s why I was deeply disappointed last week to read that the World Health Organization (WHO) has barred a group of people with certain global crime fighting ideas from participating in their “member state” meeting on substandard/spurious/falsely-labelled/falsified/counterfeit medical products being held today through Wednesday in Buenos Aires, Argentina. See the Reuters article “Row flares over global fight against fake medicine” and see Roger Bate’s introduction to the group’s position “How to achieve international action on falsified and substandard medicines” and don’t miss the full PDF containing the group’s well-stated position.
The dispute is Continue reading Pharma Anti-Counterfeiting and Serialization
I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution Security. As promised last Thursday, here is my analysis. Overall I’d say it is a very serious attempt to develop a raw text that everyone can agree on.
But the only reason everyone can agree on it is that there are literally hundreds of multiple-choice options (they call them “policy choices”) built in–kind of like Mad Libs. Anyone can use a marker to go through and cross out all the choices that they don’t like and they would end up with a bill that their constituency would probably accept. The problem is Continue reading Congressional Legislation Development: Mad Libs Edition!
Yesterday I received several notices of the latest attempt to introduce a national drug supply chain security bill into Congress. That is, the publication of a discussion draft produced by the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee. Download it in PDF form from Senator Harkin’s website.
I wanted to get this notice out this morning but I won’t have a full analysis until my Monday essay. Stay tuned for that.
The email I received included the following explanation from Kathleen Laird of the HELP Committee: Continue reading The Congressional Draft Proposal to Improve Drug Distribution Security
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