Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush.  One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs”, and “…develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.”

The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010.  That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it.  The text of the FDA’s standard says as much.

By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)?  I don’t think so.  In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”).  Alignment shouldn’t be confused with surrender.  The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.

WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD

In the case of the SNI aligning with GS1’s SGTIN we got the following things:

• An existing robust global standard that has multiple years of use by multiple industries—including the pharma supply chain—and in multiple countries;
• Automatic interoperability with the regulatory requirements of other countries who have, or will, align with the SGTIN;
• Automatic interoperability with all of GS1’s other—current and future—standards that use the SGTIN as a key component (see my essay “GS1 Standards – Betcha Can’t Use Just One!”);
• Automatic interoperability with lots of existing third-party applications that are already designed to work with the SGTIN.  Some companies in the supply chain had already deployed these systems and now they can proceed with further deployments knowing that by doing so they will remain compliant with the FDA SNI standard;
• Widespread existing knowledge and understanding of the SGTIN and how to apply it within the industry.

These are huge benefits.

In contrast, China’s State Food and Drug Administration (SFDA) chose to expand the use of their own existing product serialization standard to include drugs, but that standard does not align with the GS1 SGTIN.  That will probably benefit the government there and perhaps domestic companies who are serving only the China market, but it could also complicate international trade in pharmaceuticals where companies from China are a party.

SO SHOULD FDA CEDE ALL STANDARDS DEVELOPMENT TO GS1?

The fact that FDA’s choice to align with GS1’s SGTIN provided so many benefits should not be taken as a sign that the FDA should simply mandate other GS1 standards to fulfill their obligation under FDAAA of 2007.  It made sense when it came to the foundational SNI to use the foundational SGTIN as the aligned standard, but that’s about as far as you can go.  GS1 doesn’t have standards that are out-of-the-box usable for “…validation, authentication, and tracking and tracing of prescription drugs”.  Those are high-level applications, not foundational standards like SNI.

Yes, you can use some of GS1’s standards as the basis for applications that might validate, authenticate and track & trace prescription drugs—likely including GS1’s Electronic Product Code Information Services (EPCIS) and related standards—but it is much harder for the FDA to “align” with those standards without a lot more FDA-specific explanation of exactly how they might be applied to implement those applications.  That FDA-specific explanation would be the description of an authentication and track & trace “model”, which might use GS1 standards under the covers.

The best thing GS1 has done that the FDA might be able to use to help them formulate their authentication and track & trace “standards” is the output of the GS1 Healthcare Network Centric ePedigree (NCeP) work group.  That group simply documented the characteristics of eight different ePedigree models that would be based on GS1 EPCIS.  The documentation amounts to a concise “catalog” of authentication and track & trace models that the FDA could use to help them select a viable model for their “standard”.  (They should also see my RxTrace essays, “The Viability of Global Track & Trace Models”, “Plateaus of Pharma Supply Chain Security”, “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach” and a bunch of others in my back catalog.)

Regardless of what FDA chooses to do in the development of the standards mandated by Congress, they should not and certainly will not cede it all to GS1.  The mission of the FDA is completely different from the mission of GS1 and the standards they each publish reflect that difference.  While I wouldn’t be surprised if the FDA authentication and track & trace standards include some references to GS1 technical standards, they will need to provide a lot more additional details than they did in the SNI standard.

We shouldn’t have long to wait to get an initial glimpse of where the FDA is going with their track & trace standard.  As I reported in my essay “InBrief: FDA To Publish Track & Trace Standard By Year End”, we should see the first draft by the end of the year.

Dirk.