FDA Tea Leaves: Are They About To Delay The November Deadline?

Drawing of tea leaves to be read
Can you read these?

I don’t have any hard evidence, but there are some interesting things out there that just might point to a coming delay in the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for drug manufacturer serialization and electronic transaction data exchange.  Let’s call them “tea leaves”, and let me attempt to “read” them.  They might turn out to be meaningless, so don’t take any action based on such speculation.  And if you know something more, or interpret something differently, leave a message.

During the Cold War the U.S. government and the press attempted to figure out what was going on in the Soviet Union by paying attention to who was standing next to whom during military parades.  Our exercise might seem a little like that.

  1. FDA DSCSA “Listening” Session with Pharma Industry Associations
    On April 25 the FDA held an invitation-only meeting with pharma industry associations to hear how the industry is progressing toward the DSCSA November deadline. I wasn’t there, but I’ve heard a description of what went on during the meeting.  Apparently there were about 40 people present from the industry and there were apparently almost as many people present from the FDA.  That’s an indication that the FDA wants to expose a large number of staffers to the progress and issues companies are experiencing as they prepare to comply.

    What they heard was a sobering estimate that only 50% of the packaging lines of contract manufacturers will be ready to apply serial numbers by the deadline.  I am told that most of the manufacturer’s industry associations attending asked FDA for a 1 year enforcement discretion, and significantly, they asked for that to be announced by the FDA “sooner rather than later”.  They offered a very sound argument for an early announcement.  It would avert the implementation of compliance strategies that include building-up inventories of non-serialized drugs in advance of the deadline, which could have ill effects on companies if FDA ultimately announces a delay at the last minute (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”).

    That is, it would be very unfortunate if companies were to build-up their inventories only to have the deadline pushed out at the last minute.  That build-up takes time to execute and more time to sell off after the deadline.  A build-up that isn’t necessary would result in greater numbers of units being the subject of grandfathering, even after the pushed-out deadline, thus prolonging the non-serialized drug era.  This is a very logical argument.  Will the FDA adopt it?

    By the way, apparently when the downstream industry associations spoke, they noted the possibility that the FDA might use enforcement discretion on the manufacturer’s serialization deadline, and they asked, if that comes to pass, that all subsequent deadlines be pushed out a comparable amount.  No sense letting the manufacturers get all the goodies.

  2. FDA Reopens Docket for the Next 12 Months
    In April of last year, the FDA opened a docket for use by the industry and the public to submit written comments to the agency “…regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the…DSCSA.” At that time, the docket was open for a mere 30 days (see “HDMA Responds To FDA Pilots RFC”).

    Two weeks ago, the FDA re-opened that same docket, and this time they will leave it open for a full 12 months.  If companies were going to have to be fully compliant with the serialization and electronic data exchange requirements only seven months from now, why would the FDA bother leaving the docket open for a full five months beyond that date?  Does this indicate they are preparing to push out the deadline, in which case, they would want to continue to collect information about those issues?

  3. The DSCSA Deadline Nobody’s Talking About Is Only 3 Weeks Away!
    There is an often overlooked deadline that is only 3 weeks away, and if it passes without the publication of the overdue DSCSA guidance documents, the FDA will be forced to delay the November serialization deadline. Do I have your attention?  Here is a quick overview.  The DSCSA section that requires the FDA to publish guidance on waivers, exceptions and exemptions by November 27 of 2015 (Section 582[a][3]), which they missed a long time ago, includes a subsection that says:

    “(C) PROCESS.—In issuing the guidance under this paragraph, the Secretary shall provide an effective date that is not later than 180 days prior to the date on which manufacturers are required to affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction into commerce consistent with this section.”

    One hundred eighty days before November 27, 2017 is May 31, 2017.  That means the FDA not only has to publish the waivers guidance, but the deadline for applying for such a waiver can be no later than May 31, 2017.  Even if that guidance is published today, you can’t expect companies to react so quickly that they could have all necessary applications in within 3 weeks.

    If/When the FDA misses this deadline they will have no choice but to delay the November deadline.  Missing this deadline is not the same as missing the original 2015 deadline for publishing the guidance.  By missing that deadline you could argue that it would take months before it caused any harm in the supply chain (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  That deadline was almost arbitrary.  It provided plenty of time for the FDA to publish, and then lots of time for the industry to absorb the guidance and use it to prepare for future deadlines.

    But the May 31 deadline is different.  It is to provide enough time for the FDA to evaluate and respond to applications for waivers, exceptions and exemptions, and then time for the applicants to adjust their plans for meeting whatever the FDA demands in their response.  Obviously Congress did not expect the FDA to go right up to the deadline without publishing.  In fact, even if they publish today, having only 3 weeks to submit the necessary application, and then less than six months to implement would be a huge hardship.

If only the first two things had happened, I wouldn’t be writing this essay.  But when all three have happened, I’m willing to bet we are going to see an FDA announcement about enforcement discretion or some other delay in the next three weeks.  Whoops, given how slow to react the FDA has been with regard to the DSCSA, I’d better give myself an extra week or two so the FDA can miss this deadline too.

Disclaimer:  This is a speculative prediction based on observations and hearsay.  I do NOT recommend that anyone back off on their efforts to meet the DSCSA on time, until and unless the FDA makes an announcement.  While I’m at it, I am not a lawyer and none of this is  legal advice.  But if you need a better understanding of the text of the DSCSA, get a copy of my book, “The Drug Supply Chain Security Act Explained“.  Check out the new low price!

What do you think is going to happen?  Leave a comment below.