FDA Delays UDI and FSMA: What About DSCSA?

Image of November 27, 2017 calendarA few weeks ago I predicted that the FDA would soon announce a delay in enforcement of the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for serialization of drug packages (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”, see also “Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance”).  As I said, I don’t have any “inside information”, I’m just looking at the evidence that we can all see.  I provided links to the public information I used for evidence so you can decide for yourself.  Don’t just take my word for it.  It is entirely speculation.

Now there is new evidence that the FDA is in a “delay” mood these days.  In the last 4 business days the FDA has announced their intention to push out some of the deadlines of both the Unique Device Identification (UDI) final rule and the Food Safety Modernization Act (FSMA) (see “FDA Delays UDI Requirements for Low-Risk Devices”, and “FDA Intends to Extend Compliance Dates for Agricultural Water Standards”). 

In both cases, they cite the complexity and difficulty companies are facing when trying to prepare for those deadlines.  In the case of UDI, the deadline being extended was originally to go into effect over three years from now, and it was pushed out by two more years!  In the case of the FSMA deadline, it was originally to go into effect in January of 2018 (and 2019 and 2020).  They have not even figured out yet when an appropriate deadline would be, so they will announce that later.

For us in the pharma supply chain, these announcements are just two more small indications that lend credence to my prediction that we will see a delay in the November serialization deadline.  From my perspective, it is impossible to determine what is going on at the FDA right now, but it seems logical that there are some adjustments being made due to the new administration (see “One Immediate Impact of President Trump On The FDA”).  Delays might be the new  go-to strategy.