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?
Category Archives: DSCSA
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
Does Interoperability Change In 2023?
There are many terms specifically defined within the Drug Supply Chain Security Act (DSCSA) text (see “Don’t Skip The DQSA Definition of Terms Section”). One of the words you should expect to be defined there is “interoperability”, because it plays such a big role in the system(s) that must be used by everyone in the supply chain after November 27, 2023. That is, the “…interoperable, electronic tracing of product at the package level…” that is at the core of the Enhanced Drug Distribution Security (EDDS) phase that is defined in Section 582(g). But surprisingly, the term is not defined in the text.
In fact, it appears to be left up to Continue reading Does Interoperability Change In 2023?
DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again
A couple of days before President Obama signed the DQSA legislation back in 2013 I published an RxTrace essay that looked at what was going to be necessary in the next year from the FDA and the industry (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“). The initial standards necessary at that time were for data exchange, and the FDA had one year to come up with them. My essay was about the need for the industry to work with the FDA to come up with the standards that would work. The FDA didn’t have the expertise or the knowledge of how the supply chain operated and so I felt it was imperative for the industry to help them out.
Fast forward to today. Rather than data exchange standards, the FDA is facing Continue reading DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again
FDA DSCSA Public Meeting #1 Exposes Gulf In Goals
The FDA held the first of three scheduled DSCSA public meetings last week. This one focused on:
- The vision for 2023; and,
- The enhanced drug distribution security (EDDS) needs related to tracing prescription drugs at the package level.
The meeting started off with short presentations by representatives from:
- Biotechnology Innovation Organization (BIO)
- Association for Accessible Medicines (AAM)
- Healthcare Distribution Alliance (HDA)
- National Association of Chain Drug Stores (NACDS)
- American Pharmacists Association (APhA)
In the short time they were each given, these speakers Continue reading FDA DSCSA Public Meeting #1 Exposes Gulf In Goals
Identifying Trading Partners Under the DSCSA
The FDA published a new draft guidance yesterday with explanations intended to dispel various kinds of confusion over the five kinds of trading partners defined in the Drug Supply Chain Security Act (DSCSA) text. They are clearly on a roll, with the combination of the recent draft compliance policy, pilot and public meeting announcements, and now this draft guidance exceeding all of the DSCSA-specific communications they produced last year. We’ll know for sure that the logjam has been cleared when we finally see one of the four mandated guidance documents that were originally due on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“). But what about this new one? Continue reading Identifying Trading Partners Under the DSCSA
DSCSA Verification and Suspect Product
Last week I wrote about the debate over the number of possible responses to verification requests in any potential solution the industry might adopt to meet the Drug Supply Chain Security Act (DSCSA) (see “DSCSA Red Light Green Light: Verification Responses”). Today I want to take a closer look at a related issue: the relationship between verification and suspect product. Most specifically, does a failed verification automatically force a product into the suspect product category? The answer might surprise you. Continue reading DSCSA Verification and Suspect Product
DSCSA Red Light Green Light: Verification Responses
There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request. Some say two: “Red light” or “Green light”. And others say three: “Yes”, “No”, or “It’s Complicated”. This might seem like a minor question, but people on each side are surprisingly passionate about their positions. Let me explain. Continue reading DSCSA Red Light Green Light: Verification Responses
