The first installment of the Saying The Quiet Things Out Loud Podcast where we will focus on current topics and trends in the pharmaceutical serialization space.

In today's episode we talk through the recent letters to the FDA regarding the upcoming November DSCSA milestone. We talk about the consistent themes of those letters, but also identify the critical questions we, as an industry, should be raising to the FDA.

Thanks for listening!!

Full Transcript- https://www.lifescienceserialization.com/2023/08/saying-quiet-things-out-loud-episode-1.html

Executive Summary:

• Today's episode focuses on the recent letters addressed to the FDA asking for more time to ensure the industry is ready to comply with DSCSA
• Everyone agrees more time is needed, but the critical question to be raising is "What do we do that additional time?"
• The wrong answer for the industry is to ask for additional time only to continue down the same path
• We, as an industry, need to do a self evaluation/self-reflection of the right way to go about enabling interoperability between entities. What we've collectively been doing thus far is not the right answer.
• This does not mean we start from scratch- but we need to accept the reality that we completely missed on establishing interoperability
• Despite what any vendor, conference or advertisement might claim- there is no true concept of a collaboration network in use across the industry today.
• A true collaboration network is the key foundational layer to enabling interoperability
• Major industry participants have done self-reflection/self-evaluation of their serialization journey and came to the conclusion that significant changes were needed- Why wouldn't we do the same as an industry?
• If we continue down the same path, in 1 to 2 years we'll simply end up in the same place as we are today- without having addressed the real issues that will lead to supply chain disruptions/drug shortages which are the severe data quality/integrity issues that the industry is only now starting to realize as more companies start paying attention to serialization data
• The next 2 months will shape the next 2 years in pharma serialization- if we are given more time, let's taken advantage of it by course correcting and setting a vision for a true supply chain interoperability