Brian Nightengale, EVP and President, Healthcare
The FDA’s decision, formally announced Wednesday afternoon, to stagger enforcement of DSCSA compliance across pharmaceutical supply chain stakeholders is a great example of a government entity listening to the people and organizations it serves and acting in such a way as to benefit all those concerned. I applaud the FDA's decision and am confident that this step will play a significant role in helping our industry fully achieve the goals of the Act.
With the end of the stabilization period looming, trading partners throughout the healthcare space have been moving aggressively to establish electronic interoperability, ensure the uninterrupted flow of both product and serialized EPCIS data and enable the required traceability. And significant progress has been made. However, at the time of the FDA’s announcement, it had become obvious to those closely involved that, despite these concerted, collective efforts, achieving full readiness and compliance -- across the industry -- was far from guaranteed.
Now, with the updated enforcement plan, trading partners can continue to institute processes, train personnel and pursue compliance inside a window that more comfortably accommodates the operational enhancements that industry members must make in order to secure the pharmaceutical supply chain. Still, it is incumbent on all trading partners that their efforts neither slow nor abate and that achieving full DSCSA compliance remains a top priority.
There’s no question that the work done so far has been effective in strengthening the integrity of the pharmaceutical supply chain and enhancing patient safety. However, by giving healthcare trading partners additional time to achieve compliance, the FDA has acted proactively and thoughtfully to prevent potential disruptions in the distribution and dispensing of medications—a realistic possibility due to the current data flow challenges.
We have time now to do what we all know must be done. Let’s be sure to make full use of it.