Happy New Year.  I wanted to kick off 2018’s first blog post with a recap of the December FDA meeting on DSCSA.  I have joked around with many of my colleagues and contemporaries that this unusual two-day meeting format was notable not only for its length but also for the critical DSCSA related topics that were to be discussed.  The range of agenda topics included discussions around future data architecture and data exchange standards, including the need for aggregation/inference. Playback of the meetings, are now available on the FDA’s website at:

https://www.fda.gov/Drugs/NewsEvents/ucm559090.htm

Overall, there were not any real surprises coming out of the meeting.  There seems to be overwhelming support for adopting the GS1 standards data architecture and as far as the first step towards interoperability utilizing blockchain technology for data exchange.  It is important to point out that overall as an industry, we recognize the limited lifespan of the current EDI infrastructure driving DSCSA today and although alternative approaches exist all of the industry efforts and energy is coalescing around making blockchain the way we manage the drug supply chain in the United States.  I will be posting later this year specifically about our plans around expanding our blockchain offerings, as we are currently leading one of the nation’s DSCSA blockchain pilots in conjunction with Systech, a strategic partners within the Center For Supply Chain Studies research.

https://www.c4scs.org/

The meetings wrapped up with several scenarios that were posed to the group for discussion as well as future state scenarios and questions about the benefits of an interoperable system.

The following is a short video of me answering one of the questions about the future stage of drug recalls:

http://bit.ly/FDARecall126

At the end of January,  we will be kicking off our DSCSA webinar series this year, where we will be recapping all of the FDA Guidance and industry news from 2017 and look forward into DSCSA in 2018.  Details and a registration link for the webinar are listed below:

DSCSA Planning 2018

Wednesday, January 24, 2018

2 PM Eastern Time

http://bit.ly/DSCSA2018