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: Continue reading Should FDA Cede All Standards Development To GS1? →