On October 17 – 19, 2017 the global GS1 Healthcare community came together for their fall conference in Chicago, IL. The conference was packed with practical information for implementing GS1 Standards across every spectrum of the Healthcare industry. To cover the entire event, I’ve asked Karen Fleshman, Co-founder, COO of the Haskins Advisory Group, to cover the medical device sessions while I cover the pharma sessions. Let’s hear from Karen first. Continue reading The Fall Global GS1 Healthcare Conference
What a surprise it was to learn yesterday from Phil Taylor of SecuringIndustry that Tracelink, a traceability software vendor, has filed a lawsuit against the Healthcare Distribution Alliance (HDA), a non-profit industry organization representing the larger wholesale distributors in the United States (see SecuringIndustry, “TraceLink sues HDA over control of pharma track-and-trace data”). I had to check the calendar to see if it was April 1st.
It wasn’t. Continue reading Tracelink vs. HDA
Back on June 30, 2017, the U.S. FDA extended the product identifier requirements under the Drug Supply Chain Security Act (DSCSA) to November 26, 2018 due to insufficient industry readiness. This gives the industry an extra full year to make sure their solutions are fully integrated and tested. Are you ready? Are you done? Even those who would have been ready this November are likely to have more to do to make sure their start-ups go smoothly. What about your European Falsified Medicines Directive (FMD) strategy? That’s right around the corner too. Continue reading Sponsored: Bio/Pharma Serialization and Traceability Summit 2017
The root cause of the US opioid epidemic was made visible on television two Sundays ago. Did you see it? I’m referring to the 60 Minutes/Washington Post expose called “The Whistleblower” that aired on Sunday, October 15. But if you watched that episode with the volume up, odds are you missed the root cause. Let me explain. Continue reading Opioid Epidemic: Root Cause Exposed
The two days after the next FDA DSCSA Public Meeting, IQPC will hold their Pharmaceutical Traceability Forum | Interactive event in Washington DC. The FDA meeting will be on December 5 and 6, and the IQPC event will be on December 7 and 8. Perfect for attending two vitally important meetings, and only having to travel once. The Pharmaceutical Traceability Forum | Interactive event includes a slate of excellent speakers who will provide you with their immediate impressions of the FDA meeting that will have just occurred, and the one that was held back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”). Continue reading Sponsored: FDA DSCSA Public Meeting Q&A
The Drug Supply Chain Security Act (DSCSA) makes it clear that the FDA must work with industry stakeholders to figure out exactly how the US pharma supply chain should meet its requirements after November 27, 2023–see DSCSA Section 582(g). That section specifies “The transaction information and the transaction statements shall be exchanged in a secure, interoperable, electronic manner…”. There is no mention of the creation of an independent third-party to design or coordinate that exchange, and Continue reading A US Medicines Verification Organization (USMVO)?
Except for Medicare/Medicaid, the United States and Australia are the only countries in the world that do not rely primarily on “single-payer healthcare”. The term refers only to who pays for the healthcare of citizens, not how that care is delivered. Those two countries rely primarily on private insurance companies to act as “payers” of healthcare for most citizens and the funds used to pay are Continue reading Why Aren’t Health Insurance Companies Interested In Pharma Traceability in the US?
Last week the Healthcare Distribution Alliance (HDA) submitted nine pages of comments in response to the FDA’s Request For Comments in docket number FDA-2017-N-3857 (find their submission here). It is worthwhile for you to read because the HDA generally sets the gold standard for detailed analysis of the Drug Supply Chain Security Act (DSCSA), and because this one is particularly pertinent to discussions going on at the FDA and around the industry right now. Continue reading HDA Schools FDA On DSCSA