It’s true the last week of November 2015 came and went without any real repercussions owing to the FDA’s lack of compliance when it came to a deadline for publishing their new guidance documents under the Drug Supply Chain Security Act. This isn’t the first time that the FDA has not met its purported deadline for publishing, in fact the same thing happened last year around the same time. But what is it exactly that is causing this delay in guidance documents?
While the exact cause may remain largely unknown, this does present an opportune time to examine the logistics and funding involved in mounting this particular effort.
It’s important to note that although these guidance documents are mandated under legislation signed by the president and recognized by congress, the DSCSA is currently an “unfunded” mandate unto itself.
Without any context, that may make it seem improbable that any guidances would ever get published. However, the FDA submits an estimated budget proposal annually which outlines and supports the overall funding of Congressional Appropriations Committees and include time allocated to implementing the DSCSA.
Knowing that the funding for this mandate is not its own line item within the budget makes it seem like this could easily lead to a lack of prioritization when it comes to publishing these documents on time.
While this somewhat informal way of allocating resources to this cause may work well enough for now, it’s likely that the costs associated with implementing the “Enhanced Drug Distribution Security” (EDDS) (slated for late 2023) will require additional funds and likely a more detailed understanding of where it’s coming from and specific numbers.
In the meantime, however, we will have to wait and see how the FDA will approach this deviation from the proposed publishing date for these guidances related to the DSCSA.