I stumbled across the FDA’s recently published “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012” while surfing the PharmTech website late last week. The guide is published each year in the spring to provide a “heads-up” on which guidance documents the FDA thinks they will be able to complete and publish by the end of the calendar year.
I first learned about the significance of the annual document about 18 months ago when an FDA official explained it in a conference presentation. In response to a question from the audience about when she thought the FDA would publish the Track & Trace (T&T) standard for pharmaceuticals, she recommended that people watch for a notice of it in the “Guidance Agenda…” each year. She said that the annual guidance list was usually pretty accurate. If the T&T guidance wasn’t listed, according to the FDA official, people would know that the standard wasn’t going to be published that year. It wasn’t included in last year’s list, but it is in this year’s edition, which apparently means that we will see the standard by the end of 2012.
Congress instructed the FDA to create standards for Track & Trace, Authentication and Validation of pharmaceuticals in section 505D of the FDA Amendments Act (FDAAA) of 2007. That’s the same section that instructed them to create the Standardized Numeric Identifier (SNI) guidance that was published two years ago. In that case the only difference was, Congress gave them a specific deadline for the publication of the SNI standard but no specific date for the T&T standard. But now we know it’s coming soon.
The FDA originally published draft guidance for the SNI and then, after collecting public comments on the draft, they modified it and published it as final guidance. In my opinion, that process worked well for the SNI considering how well the final standard turned out. I assume they will follow the same process for the T&T standard.
Like the SNI guidance, this new T&T standard will probably be non-binding, but remember, one of my theories is that this Federal T&T standard just could be the standard that ends up being adopted by States in place of their soon-to-be non-standard pedigree laws (see my essay “What Happens If RxTEC Isn’t Adopted?”). If that happens, it could eliminate the existing patchwork of pedigree laws over time (maybe a long time) without the Federal government adopting any binding national pedigree regulation.
It’s hard to say, but it appears that sooner rather than later we will have a new Federal Track & Trace standard to consider.