In Absence Of FDA Guidance, Follow PDSA Recommendations

PDSA LogoThe Pharmaceutical Distribution Security Alliance (PDSA) is a coalition of companies and organizations dedicated to the safety and integrity of the U.S. pharmaceutical supply chain.  When the Drug Supply Chain Security Act (DSCSA) went into effect on November 27, 2013 the PDSA began to serve as a voice for its members in communications with the U.S. FDA.  Their preferred way of communication is through formal letters signed by their legal advisor, Vince Ventimiglia.  PDSA letters to the FDA are really interesting because they do an excellent job of providing recommendations for the FDA to consider as they prepared to publish the four guidance documents that were due back on November 27, 2015.  The FDA has still not published those documents. 


Prior to that due date, PDSA letters contained very detailed recommendations.  These include recommendations for guidance on serialization Exemptions and Waivers (see PDSA letter dated May 14, 2015) and serialization Exceptions and Grandfathering (see PDSA letter dated June 8, 2015).  In my view their recommendations reflect a solid understanding of the problems the DSCSA is designed to address, a solid understanding of the content of the DSCSA, and the realities of how the U.S. pharma supply chain actually works.  I can tell that because their detailed recommendations are incredibly rational and workable.  For example, here is an extract from the June 8, 2015 letter regarding serialization grandfathering:

“The key to determining which products are grandfathered is defining the phrase ‘in the pharmaceutical supply chain.’ PDSA believes that determination should be tied to the date on which product is packaged. Specifically, we ask the Agency to clarify that any product packaged by a manufacturer prior to November 27, 2017 or repackaged by a repackager prior to November 27, 2018 is grandfathered. A homogenous case containing grandfathered product should also be grandfathered.

“Use of the packaging date to determine whether product is grandfathered is critically important to an effective and efficient transition to serialization. Such an approach is an appropriate interpretation of the statute. The statutory obligation to serialize product requires a manufacturer or repackager, as of November 27, 2017 and 2018 respectively, to affix a product identifier to each package ‘intended to be introduced in a transaction into commerce.’ The phrase ‘intended to be introduced’ indicates that the obligation applies at the point of packaging.

“The date on which a product is packaged or repackaged is well-documented by the manufacturer or repackager and will allow the Agency to easily confirm, upon request, whether a product not affixed with a product identifier was grandfathered. …”

They wrote those words to the FDA on June 8, 2015.  Some of the words I wrote three months later (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”) are similar, but I like theirs better.  Unfortunately, I did not see their words until last week, or I would have referenced theirs at the time.


In RxTrace essays published after the FDA missed the November 27, 2015 guidance deadline, I began hammering the FDA directly for missing it (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Forfeits Opportunity To Guide Industry”, and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”).  That’s the nature of a blog (or, I don’t know, maybe it’s just the nature of Dirk Rodgers). 

But thankfully, the PDSA took a more subtle and more productive approach.  They sent more letters to the FDA, stating, as I paraphrase, that their earlier recommendations were being treated by their members as de facto industry guidance, since the FDA did not respond to those original letters to say that they were wrong (see PDSA combined letters dated March 2, 2016 and November 14, 2016).  Here is an extract from their November letter:

“There are a variety of challenges that will impact supply chain implementation of the 2017 requirements. One such factor is that guidance on grandfathering, exceptions, exemptions and waivers has not yet been released. In the absence of guidance, PDSA reached a consensus understanding of how grandfathering applies, and has moved forward with implementation on that understanding. This understanding is outlined in the attached letters that PDSA submitted to FDA on June 8, 2015 and March 2, 2016. In short, any product packaged by a manufacturer prior to November 27, 2017 or repackaged by a repackager prior to November 27, 2018 is grandfathered. A shift in regulatory expectations of the grandfathering provision of DSCSA at this stage would significantly impact 2017 preparedness.”

A shift in expectations at this stage would “significantly impact 2017 preparations”.  In “Dirk words”, they are saying, “It’s too late.  If you publish grandfathering guidance now, don’t try to impose something other than what we previously recommended.”  Or, as I word-hammered in an essay last October, “By delaying publication so long, the FDA has forfeited their opportunity to establish grandfathering guidance.

But the FDA did not respond to those more recent PDSA letters either.  If they strongly disagreed, they should have responded, and done so publicly.  But since they didn’t, we can assume they agree…at least until they say otherwise.

The full PDSA letters are highly recommended if you have not read them.  Companies should feel free to use their recommendations as a stand-in for non-existent FDA guidance on exceptions, exemptions, waivers and grandfathering.  You will be in very good company when you do.