Why are the supply chain businesses that help move medicine across New Jersey thinking about a deadline that was set early into former President Barack Obama’s second term?
Because it hasn’t arrived just yet.
There’s still a year from the final implementation of the Drug Supply Chain Security Act, which was first established in 2013. In essence, it’s requiring life science companies and their supply chain partners to categorize and track products in a more uniform, digital-driven way. Industry leaders expect it to be a major adjustment, but a worthy supply chain security endeavor.
Antares Vision Group, an Italian company with a Mount Laurel base, is one of the supply chain companies that views itself as a leader in digitization and innovation in the life science supply chain. It also views itself as ready for the completion of a decade-plus implementation process of this Obama-era rule.
Chris Collins, the company’s North America sales manager, said the regulation was supposed to take full effect this November, but that deadline was extended an extra year to avoid undue stress on the drug supply chain or any drug shortages.
“The whole goal of this FDA-originated rule was to make supply chains more trustworthy, less prone to counterfeiting,” he said. “Even if that’s less of a problem in the United States than other countries, it still makes sense to know what a bottle of a drug is — where it has been and when — as it moves from a factory floor to the hands of the pharmacist at CVS.”
The longstanding problem of drug counterfeiting globally has only increased in the years since the Drug Supply Chain Security Act was introduced. Cases of counterfeits, thefts and illegally diverted products doubled between 2014 and 2019, according to the Pharmaceutical Technology Institute.
Although the regulation has already introduced some compliance measures over its 10-year-long phase-in, the final implementation deadline is when pharmaceutical companies in New Jersey and elsewhere will be asked to implement a serial number system for each product shipped along the supply chain.
One effect of that serialization mandate is that there’s going to be data generated that pharma companies will want to somehow leverage. Antares Vision Group is looking at pairing that information with advances in artificial intelligence technology to help companies with tracking manufacturing efficiencies, the quality of processes and predicting equipment maintenance needs.
“In a regulated environment such as the pharma, AI perks ears,” Collins said. “Life science divisions are typically slow to technology. They rely on validated systems that have to be proven not to be altering processes in a negative way.”
The local company, and the industry around it, is still in the early stages of utilizing machine learning innovations.
Meanwhile, it’s continuing to build on platforms, such as the DIAMIND system it introduced this year for the life sciences and other industries, which better documents the journey of products from origin to its destination, Collins said. That new cloud-based data management platform also implements the serialization solutions for life science firms they’ll be required to have going forward.
“We’re working to ensure transparency in the supply chain and to keep it running uninterrupted,” he added.