Last Monday the Health Subcommittee of the House of Representatives Energy and Commerce Committee, chaired by Joe Pitts (R-PA16), published their own discussion draft of a national pharmaceutical track & trace bill and then on Thursday they held a hearing to discuss elements of it with a select group of witnesses. The draft was sponsored … Continue reading The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’
I finally had time to listen to the recording of the original webcast of the interview with Virginia Herold, the Executive Officer of the California Board of Pharmacy that occurred on March 20, 2013. Shabbir Dahod of TraceLink, a supplier of ePedigree solutions and other supply chain products and services, asked a series of very … Continue reading Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy
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 … Continue reading Congressional Legislation Development: Mad Libs Edition!
That’s right. We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it. I will explain, but first, what is a drug recall? Today, when the manufacturer decides that a recall is necessary—either on their own or through a request by the FDA—they issue a … Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls
I did not participate in the development of the Pharmaceutical Traceability Enhancement Code (RxTEC), a proposed Congressional bill that was created by the industry lobbying group known as the Pharmaceutical Distribution Security Alliance (PDSA). In fact, while I was aware that a group had been formed last year I wasn’t aware that they were working … Continue reading What If RxTEC Isn’t Adopted?
Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs. This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security. For this reason it is … Continue reading Pew Prescription Project: After Heparin
Conversations about the merits of various pedigree and authentication models usually start from dissatisfaction with some characteristic of the current GS1 DPMS pedigree model. I maintain that the design of DPMS—including its perceived flaws—is merely a reflection of the current state and federal pedigree laws and regulations. Characteristics that people don’t like—like digital signatures, a … Continue reading What are Pedigree Laws Trying to Accomplish Anyway?