FDA Forfeits Opportunity To Guide Industry

fda-building-2016-10-14-16-38-20I hope you were able to attend last Friday’s FDA DSCSA Public Meeting at FDA’s White Oak, Maryland campus (see “FDA To Hold DSCSA Public Meeting”).  If you missed it, make sure you listen in on the recording that the FDA will provide on the event webpage.  You can also submit written comments through that page as well.  The event was called “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and it consisted of very brief introductory comments by the FDA followed by presentations made by attendees who applied for a speaking slot.  Presentations covering progress toward the November 27, 2017 DSCSA serialization requirements were made by:

Anita Ducca and Brian Waldman Healthcare Distribution Alliance
Heather Zenk AmerisourceBergen
Scott Mooney McKesson
Mark Hendrickson Generic Pharmaceutical Association
Eric Marshall Pharmaceutical Distribution Security Alliance
Riya Cao LSPediA
Susanne Somerville and Eric Garvin The LinkLab
Mike Rose Johnson & Johnson
JP Allard Optel Vision (Open-SCS)
Chip Meyers UPS

The FDA was represented by Dr. Ilisa Bernstein, Dan Bellingham, Dr. Connie Jung, Anita Richardson and Kate Bent.  There were about 150 people in the room.

The FDA Panel
The FDA Panel.  Click image to enlarge.


There were several issues that were brought up by multiple speakers.  One was whether or not aggregation is required by the FDA by 2019 as the big wholesale distributors are demanding (see “When Will The DSCSA Ever Require Investments In Aggregation?”, “Wholesaler Confusion Over DSCSA Aggregation Explained” and “Aggregation –> Chargeback Accuracy –> ROI”).  Dr. Bernstein put that one to rest by asking one speaker to identify which clause of the DSCSA leads him to believe that aggregation is a statutory requirement before 2023.  Of course, there is no explicit requirement like that, so the demands of the wholesale distributors result in a business requirement for aggregation, not a regulatory requirement.  A few people made statements making it clear they understood the difference.  Not everyone did, however.

One novel proposal for addressing the problem of aggregation was made by Mark Hendrickson of GPhA.  He called on the FDA to push out the wholesaler’s 2019 requirement for verifying all saleable returns using the serial number, until November of 2023.  That way the wholesale distributors would no longer need aggregation data in 2019 and drug manufacturers would be able to defer those investments until just prior to 2023, when they almost certainly need to capture that data for regulatory purposes.

Another reoccurring problem is the way some state governments are treating the preemption provisions of the DSCSA (see “Preemption: What Does It Mean?” and “The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA”).  Apparently some are going beyond what the DSCSA allows them to do.  Scott Mooney of McKesson gave the example of a new requirement in California that requires third-party logistics providers (3PLs) (see “3PL Operation Under The DSCSA”) who ship into their state to be licensed in their home state.  Some drugs shipped into California originate from McKesson’s 3PL distribution center in Tennessee, a state which does not yet have a 3PL licensing category so it is not possible for McKesson to apply for one.  Licensing of wholesale distributors and 3PLs is another program that the FDA is behind on implementing.  Chip Meyers of UPS’ 3PL business echoed Mr. Mooney’s concerns.


Questions and concerns around grandfathering were raised by most speakers.  The industry is desperate for guidance from the FDA on this topic and that was made clear by several speakers and questioners during the Q&A at the end of the day.  All the FDA representatives in the room could say about it is that they are “still working on” the grandfathering guidance and that they hope to publish it “soon”.  “Soon” is exactly the same timeframe that was given by Dr. Jung back in June at the GS1 Connect Conference (see “FDA Speaks At GS1 Connect”).  Most recently I have speculated that the four overdue guidance documents are probably stuck in Office of Management and Budget (OMB) review, so I was kind of shocked to hear that the agency is actually “still working on” the grandfathering guidance (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”).

The most revealing comments of the day came from Mike Rose of J&J.  Because of the unique way the J&J corporation is structured and operates, it is facing what is probably the most complex implementation of the DSCSA of all members of the supply chain.  As I understand it, J&J is a collection of a large number of semi-autonomous business units, each with their own DSCSA impact.  Overall, the company is somewhere near the top of the list of drug manufacturers who have the most packaging lines that need to be converted to apply serial numbers to individual packages and homogeneous cases to meet the DSCSA by the end of November next year.  Because of their unique situation, J&J has one of the largest and most knowledgeable teams of people focused on getting the job done right, and on time.  According to Mr. Rose, they are making good progress, and they are on track to meet the deadline, not only with serialization, but also aggregation and data sharing with trading partners.

Mr. Rose did not mention grandfathering in his presentation, so someone asked him how J&J was planning to handle it.  He acknowledged that they interpret the DSCSA to allow manufacturers to ship non-serialized drugs after the November 27, 2017 date as long as those drugs were manufactured before that date.  And that’s what they are going to do, because they project that they will still have non-serialized drugs in their inventory at that time.

Congress gave fda-meeting-2016-10-14-15-33-35the FDA instructions to determine whether or not manufacturers could continue shipping non-serialized drugs after the deadline, and if so, exactly how that could work.  Their deadline for doing so was November 27, 2015.  Because we still do not have their guidance, the industry could not wait.  Large companies, like J&J, had to figure out how they were going to meet the overall deadline and they had to solidify their plans a long time ago.  It is clear from Mr. Rose’s comments that it is now too late for the FDA to tell them otherwise.  By delaying publication so long, the FDA has forfeited their opportunity to establish grandfathering guidance.  Companies—big and small—will be incapable of moving up their serialization programs now, even if the FDA were to publish their grandfathering guidance tomorrow with anything more restrictive than “drugs manufactured after November 27, 2017” (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”).

And the same goes for the other guidances that are overdue.  The FDA has squandered half of the industry’s time necessary to comply with any guidance related to the application of the DSCSA product identifier (see “The DSCSA Product Identifier On Drug Packages”).  The other guidance this applies to is the one that was to establish a process for use by drug manufacturers to obtain exceptions to the product identifier requirements due to packages that are too small or otherwise unable to accommodate the full DSCSA product identifier.  I’ve spoken to a number of people from companies with these products and they are literally pulling their hair out because they have no way of applying for such an exception, so they fear they will be charged with a violation.  In my view, by using up half of the time available to address this problem, the FDA has, again, forfeited its opportunity to challenge any company who fails to apply a DSCSA product identifier by the deadline because they believe it to be too small, or otherwise incapable.

One solution to these problems would be for the FDA to extend the deadline for applying the DSCSA product identifier to be two years from the date that they publish these two guidance documents.  That way, the FDA could take as much time as they need, and drug manufactures would regain the time that Congress intended them to have so they could meet the requirements.  Of course, that would require pushing out all remaining DSCSA deadlines by the same amount of time, including the start of the Enhanced Drug Distribution Security (EDDS) phase in 2023.  I don’t think they are likely to do that, but it is always a possibility.


Up until this meeting I was giving the FDA the benefit of the doubt.  I chose to believe that they were working diligently behind the scenes and it was the OMB that was holding things up.  After Friday’s meeting, I’m no longer so sure they have even a single person working full-time on DSCSA implementation.  If true, that would be shocking, considering the thousands of people and billions of dollars that are being spent by the industry to prepare for this major change in the way drugs are identified and packaged for the U.S. market.  This is the third DSCSA public meeting held since the law was passed (see “The 2014 FDA DSCSA Workshop” and “The 2016 FDA Pilots Workshop”).  By my notes, all three of these meetings were specifically designed to eliminate any possible release of information about what the FDA is thinking.  When should we expect the FDA to provide even the least bit of help to companies who are honestly trying to meet the law on time?  Is this really what Congress intended when they enacted this law?