Sponsored: FDA DSCSA Public Meeting Q&A

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

A US Medicines Verification Organization (USMVO)?

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)?

Why Aren’t Health Insurance Companies Interested In Pharma Traceability in the US?

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?

HDA Schools FDA On DSCSA

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