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