On Oct 9, 2024 the FDA announced further delays to the milestone of the DSCSA regulation. The new dates give manufacturers 6 additional months, wholesalers 9 additional months and non already-exempt dispenser an additional year.

But will this additional delay really make a difference? Listen to hear our thoughts/opinions on what the FDA and Industry really need to be doing if we ever want to get to a point that DSCSA is fully and strictly enforced.

We discuss the signifcance (or insignificance) that was Nov 27, 2023. What do companies need to know going forward as well as a look back on the last 10 years

We also dive into the new DSCSA Portal. What it's used for today, how that impacts company's SOPs and how it will bring the FDA (quickly) to a decision that has long hindered interoperability across the industry.

I hope you enjoy!

FDA DSCSA Portal: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-portal-cder-nextgen

This week we talk about a service offering from Jennason called doss digital which helps companies leverage no code/low code technology to build business applications that solve business challenges quickly and cost effectively.

***If you take away nothing else from this episode- skip ahead to minute 13:18 to see a DSCSA relevant business application built in 2 minutes***

Learn More: https://doss.digital

00:00 Introduction

03:45 Introduction to QuickBase

05:21 Engaging with doss digital

13:18 Smart AI Builder Prompts

22:30 doss digital's No-cost/No-commitment offer

We are back with episode 5 of the Saying the Quiet Things Out Loud Podcast. Today we discuss how one single email can provide significant insight into your serialization vendor's position on key topics such as interoperability as well as their ability to support critical implementation and ongoing support operations including testing and data reconciliation.

To make this as easy as possible we did the work for you. Below is a link to the email referenced in the episode. Copy/Paste and send it off to your vendor:

https://www.lifescienceserialization.com/2023/10/the-email-every-company-should-send-to.html

And when you hear back from your vendor- let me know your thoughts!!

Other important resources mentioned in this week's episode

NABP Pulse- https://nabp.pharmacy/pulse/

Initial NABP Pulse Partner Program Press Release (Say that 5 times fast)- https://nabp.pharmacy/news/news-releases/nabp-launches-pulse-interoperable-partner-program-to-accelerate-interoperability-in-drug-supply-chain/

Jennason Serialization Test Tool- https://jennason.com/solutions

Solution Demo- https://youtu.be/JQdUON1fZBI

FDA EDDS Guidance- https://www.fda.gov/media/171666/download

2 quick takes and the announcement of the Jennason DSCSA Trading Partner Directory

• Introduction
• Quick Take #1- DSCSA 'stabilization': Don't let vendors fool you into rushing
• Quick Take #2: NABP Pulse and the curious case of who's missing

https://nabp.pharmacy/news/news-releases/nabp-launches-pulse-interoperable-partner-program-to-accelerate-interoperability-in-drug-supply-chain/

• Announcing the Jennason DSCSA Trading Partner Directory

https://www.lifescienceserialization.com/2023/09/jennason-dscsa-trading-partner-directory.html

The FDA has announced a 1 Year enforcement description to the upcoming November DSCSA deadline.

In today's episode we discuss:

• A summary of the enforcement discretion
• What additional details companies should be watching for over the next few weeks
• How interoperability will be the primary focus in the industry over the next year and why its important that companies ensure their current systems and processes will allow them to take advantage of improvements in interoperability solutions going forward

Episode 2 of the Saying The Quiet Things Out Loud podcast.

Part 1

• The next 30 days. What pharma entities need to watch for related to DSCSA
• Why companies should be building their contingency plans now for if the FDA does, or does not, decide to act

Part 2

• Misleading information- How to filter out the predatory marketing from serialization vendors that flooded the market in the past week
• Cutbacks and layoffs in biotech- How companies can find significant cost savings in their serialization spend

Executive Summary:

• Balderson/Kuster letter to the FDA sets a response date of Sept 15. We should focus on that date for when some type of insight as to the Nov DSCSA deadlines will be revealed.
• Any action taken by the FDA that doesn't give Manufacturers more time (in addition to wholesalers/dispensers) will be worthless in terms of avoiding disruption.
• Companies need to be planning now for both scenarios- where the FDA does provide more time and where the FDA does not.
• If the FDA grants more time (as expressed in Episode 1) the first things companies should do is a self-evaluation of whether they are really on the right path.
• Predatory marketing/advertising from serialization vendors has spiked in the last week (and likely will continue for the next 1-2 weeks) as they try to take advantage of companies who are notably behind.
• If you're one of those companies- Hurry but don't rush, rushing leads to bad decisions- which has happened too often in this space as companies believe vendors promise of an 'easy button' for compliance. Good information is out there and shouldn't cost you a dollar (like emailing scott.pugh@jennason.com with any questions).
• The recent layoffs and cutbacks in pharma/biotech is unfortunate. Companies in tight financial situations, and even those that are not, would be well served to look at their serialization spend as one (of many) ways to cutback.
• The fact remains that many companies are significantly overpaying for their serialization systems. This post over a year ago provides a baseline for serialization system pricing https://www.lifescienceserialization.com/2022/07/a-baseline-for-serialization-l4l5.html

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