TraceLink Releases Results from FDA DSCSA Pilot Program on Top Pharmaceutical Supply Chain Challenges

TraceLink Inc. announced results from its pilot for the FDA Pilot Project Program under the Drug Supply Chain Security Act (DSCSA).

The TraceLink pilot focused on two workstreams—digital recalls across a supply network and an interoperable blockchain network solution. The pilots included 22 participating companies from pharmaceutical manufacturers, wholesale distributors, third-party logistic providers, hospitals and retail pharmacies.

The pilot employed early stage technology solutions to address top pharmaceutical supply chain challenges and establish a deep understanding of how technology can realistically ease those burdens. Both workstreams were designed to create a vision and blueprint for the data, operational processes, business systems, and network connections required to realize DSCSA 2023 compliance and to digitalize pharmaceutical drug recalls.

“The results from our pilot gleaned significant insights that will help solve different, but equally important challenges that the pharmaceutical industry will continue to face until DSCSA 2023, with both workstreams undoubtedly highlighting the value of a digital network in improving processes and efficiencies within the supply chain,” said Shabbir Dahod, president and CEO of TraceLink. “With the only established end-to-end digital supply network for the industry, TraceLink is in a unique position to help the industry begin acting on some of these pilot findings now. This includes improving processes and allowing better visibility, agility, and collaboration among supply chain stakeholders.”

Digital recalls across the supply network

Every year, drug-related recalls result in hundreds of thousands of preventable patient deaths, hospitalizations and adverse event experiences. In addition, a report published by McKinsey points to these recalls costing the pharmaceutical industry more than $4 billion in direct labor and recall management expenses; and tens of billions of dollars in potential product liability lawsuits, lost drug sales and brand erosion.

Pilot participants in TraceLink’s digital recalls workstream explored ways to solve challenges associated with today’s product recall process, plagued by disjointed systems, manual processes and long delays in communication between supply chain stakeholders including leveraging TraceLink’s emerging digital recalls network solution.

The recalls workstream identified a strong opportunity to improve the drug recalls process with the integration of bi-directional communications and digital recall notifications to bolster response times across the execution phase, which would require a collaborative effort among industry stakeholders to create an effective blueprint and roadmap for adoption.