How quickly would you be able to respond to notification of an illegitimate product in your supply chain? Or perhaps more to the point, just how good is your visibility into your supply chain?
By Rick Ruiz, Partner, Life Sciences, CSC
The US Food and Drug Administration has continued its push toward requiring greater visibility and transparency in the supply chain. A new section to the Drug Supply Chain Security Act (DSCSA) requires manufacturers to notify the agency and trading partners in the event of products posing a high risk of illegitimacy.
The section, For Manufacturers: High Risk of Illegitimacy Notifications, provides general scenarios that would require manufacturers to make notifications within 24 hours, as well as examples. This requirement is not surprising; on the contrary, I’m amazed it wasn’t mandated when the DSCSA was first drafted in June 2014.
While it creates another hurdle for manufacturers in terms of investing in the technology to meet the FDA’s demands, such technology is available and the mandate is very achievable. With the advent of the Internet of Things, it’s now much easier to have automated devices throughout your supply chain that provide you with the information to track your product in real time.
Eventually, the FDA will use Identification of Medicinal Product (IDMP) identifiers, including standardized package and batch lot IDs to track the product. This will enable a far more granular level of detail than the existing GS1 standards currently used for real-time tracking and traceability of the supply chain. It is expected that IDMP will allow you to get to a level of granularity to look for particular products and have discrete identification of products, which would mean not having to remove a whole shelf of products, but rather just those specific products deemed to be high risk.
Safeguarding the Brand
The message for companies is clear: the collection and scope of data is vastly increasing, and if you’re going to have to collect your data you might as well do it proactively to drive down your risk. While for the regulators that risk is solely about the patient, for product manufacturers it’s also about the health of the brand – once a product’s quality or authenticity becomes questionable, it’s very hard to regain public trust.
The other challenge for manufacturers is to improve collaboration with trading partners. More often than not, when a company hands over its product to a third-party logistics partner, traceability disappears because the distributor isn’t required to provide validation back to the manufacturer. The ideal situation would be for the manufacturer to be able to scan a unique serial number and get that information back from the point of disbursement, which would give them full insight into what products went out and got into the hands of the end user – the hospital, the pharmacist, or even the patient.
While that’s not currently an available option and will take a lot of collaboration, with serialization and ultimately with IDMP it will become easier to achieve.
Finally, enabling greater visibility and transparency of the supply chain will also help to strengthen the connection between the life sciences industry and healthcare. Currently in the United States, in particular, there is very little cooperation between these two industries, but we need to evolve to that model in order to improve healthcare for the patient.
Learn more about the supply chain and how to improve transparency and visibility by downloading our white paper, 5 Ways the Digital Supply Chain Drives Success for Life Sciences.