Last week I wrote about the recent FDA DSCSA Public Meeting where the FDA asked for reports on the progress of the industry toward meeting the November 27, 2017 serialization requirements contained in the Drug Supply Chain Security Act (DSCSA) (see “FDA Forfeits Opportunity To Guide Industry”). In that essay I expressed a view that the FDA has squandered too much of the time necessary for the industry to meet whatever guidance they might offer about grandfathering and exceptions for products that are too small to accommodate a DSCSA product identifier. These guidance documents are now 11 months late.
What if the delay in publishing these guidance documents is intentional? That is, what if the FDA has made a strategic decision to leave it up to the industry to figure out how to comply with these elements of the law? If so, then delaying publication of these guidance documents would be the way accomplish that. Of course, these guidance documents must be published someday. They are mandated by Congress, after all, but instead of containing proactive guidance to be followed by the industry, they could just end up documenting what the industry has already done. That is, whatever the industry has figured out on their own.
Perhaps the FDA has concluded that this is the best approach because it allows the industry to set their own achievable ways of meeting these parts of the law. Plus, the added benefit is that the FDA doesn’t have to figure out exactly what to say about them. To be able to provide guidance, you really have to know what you are talking about, and, because this is the first time the agency has had to deal with the pharma supply chain, the FDA doesn’t really have an internal knowledge-base to draw from.
There is already an example of something like this happening. Many RxTrace readers will remember the frenzy in the industry over what the FDA might say in their data exchange draft guidance that was mandated by Congress to be published by November 27, 2014, one year after the DSCSA was signed into law. Because the law was enacted later than the authors originally thought likely, that date ended up being only about 35 days before the DSCSA-mandated transaction data exchange was to begin (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act”).
The FDA did publish that draft guidance, and that time, they were right on time (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”). But because there was no time for the industry to switch from the technologies they had prepared for on their own to whatever the FDA might propose, the FDA’s draft guidance simply listed all of the technologies that were already known to be chosen by the industry. That is, that “guidance” met the FDA’s statutory requirement to publish a document, but it did very little to “guide” the industry. It merely reflected what the industry was already planning to do.
Did that experience set the model for the FDA to follow for future guidance documents? Maybe so. In fact, in that instance, the industry did successfully figure it out on their own. Any independent thinking by the FDA would likely have just gotten in the way. And data exchange technologies are just not an area the FDA has experience in—nor should we expect them to. In fact, what was Congress thinking when they imposed that data exchange guidance requirement on the FDA?
But, in my opinion, whether or not to allow grandfathering, and how it should work, and what size of a product constitutes “too small” for the DSCSA product identifier, and any potential selective elimination of some parts of the DSCSA Product Identifier on “small” products, are all too arbitrary to just leave to the industry to figure out on their own. In the instance of data exchange, the “Big-3” wholesale distributors were powerful enough, and organized enough through the Healthcare Distribution Alliance (HDA), to set their own requirements, which forced the industry to align around a very small set of appropriate technologies.
But there is no organizing force outside of the FDA to independently drive standardization of grandfathering and product identification on minimal package sizes. So I contend that this is a bad time to just let the industry figure it out on their own.
Is there any company or organization out there who might be counseling the FDA to let the industry figure these things out on their own? Maybe. In fact, during the FDA public meeting several speakers asked the FDA to leave as much open to the industry to figure out as possible. But from the number of queries I have received about these issues, I think most companies would prefer to have sound guidance on time rather than missed deadlines and silence.
If the FDA does not publish these guidance documents before the one year anniversary of their deadline (that deadline was November 27, 2015), it means the industry will have lost more than half of the time they would have had to adjust their plans and their solutions to meet these requirements. In that case, the courteous thing to do would be to push the compliance deadline out by one year.
But don’t hold your breath.