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FDA’s delay will not alter industry goals
We’ve been covering the topic of pharmaceutical traceability and compliance
with the Drug Supply Chain Security Act (DSCSA) closely for years, in part because its implications are so fundamental to how drugs will be distributed and dispensed nationally and globally in coming years. There is a lot of DSCSA-related news in this issue—see our look at how blockchain technology (aka “bitcoin”) could solve some looming DSCSA problems; how installing serialization equipment (a DSCSA requirement for most) can be the spur to modernizing the entire pharma packaging process; and how an innovative 3PL, Woodfield Distribution, is offering serialization services to its pharma clients.
So it’s more than a little disconcerting, in the middle of all this, to hear that FDA has announced a one-year delay (from November 2017 to November 2018) for the next stage in DSCSA compliance. Does this presage an eventual fading away of the entire DSCSA compliance mandate?
We think not, and it’s not because
is so invested in the topic. Securing supply chains is a topic of vital interest outside the US (where counterfeiting is more prevalent)—the global initiatives are not going away, even if they’ve been struggling to keep to their own self-imposed schedules. Most of Big Pharma is already well along with the initial steps of installing serialization equipment, and more and more contract packagers are making the investment. And while retail pharmacy has been mostly a reluctant passenger on the DSCSA train, numerous health systems—who are building out their own pharmacy capabilities, particularly in specialty products—are getting more deeply involved (they are obligated to, of course, by the law; but it’s one thing to limp along the process, and another to give it momentum).
We surmise that while industry lobbyists were probably grumbling to FDA about the looming deadline, the main reason for the delay was FDA itself, which is resource-constrained as it tries to deal with a highly complex regulatory process. Newly installed FDA Commissioner Scott Gottlieb made some bold statements about patient safety in regard to compounding pharmacies in June; recall that that regulatory framework was set up by Part One of the Drug Quality and Security Act (DSCSA is actually Part Two of that Act). It’s difficult to envision FDA tightening drug supply chain security for compounding pharmacies on the one hand, and loosening it for packaged pharmaceuticals on the other, even given all the misdirection and backtracking going on in Washington these days.
It’s also worth noting that while the November 2017 deadline has been pushed off, successive ones for 2018, 2019 and finally 2023, were not delayed.* In Europe, the Falsified Medicines Directive has a February 2019 deadline for serialized products; pharma companies operating globally will have to comply with that mandate, as well as others around the world.
The intriguing aspect of DSCSA compliance is not meeting the requirements of the law, as important as those are, but what this level of supply chain visibility will enable the pharma industry to do in coming years. We’re hearing that some pharma companies are already building use cases for their marketing, patient support and pharmacovigilance efforts. It’s not to wonder how to capture the value of today’s supply chain by DSCSA compliance, but how to stay competitive in the supply chain of 2023 and beyond.
*A timeline of DSCSA compliance deadlines was published in Pharmaceutical Commerce’s annual Product Security Report, accessible at