Life Sciences & HealthcareApril 22, 2019

FDA Pilot for Drug Supply Chain Security Act Puts Spotlight on Pharmaceutical Traceability

Safety is paramount in life sciences businesses like pharmaceuticals. People demand that…
Avatar John Martin

Safety is paramount in life sciences businesses like pharmaceuticals. People demand that the meds they use are safe and effective, and rely on regulators like the United States Food and Drug Administration to enforce the rules. That’s the purpose of the Drug Supply Chain Security Act (DSCSA). Signed into law in November 2013, the first requirements kicked in on November 27, 2014; others came onboard in stages during 2015. The total package of requirements, development of standards and the system for product tracing will continue to be phased in until the final compliance date in 2023.

The goal is to stop illegitimate drugs from entering the supply chain. To accomplish that, the Act outlines “critical steps to build an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs as they are distributed within the United States,” the notice from the FDA in the Federal Register states. The Act applies to drug “products”—a prescription drug in finished dosage form for use by a patient without substantial further manufacturing. It sets out requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers.

It’s all about traceability. Compliance means being able to authenticate provenance and quickly track lots to their source, and the FDA wants the private sector to “game up” for the task. On February 7 of this year it launched a Pilot Project Program, as part of the DSCSA, that encourages life sciences firms to sandbox innovative approaches to full electronic traceability of where a drug product has been and who has handled it. It’s a huge world of touch points to cover—every location that came into contact with the product and everything that happened in-between, across a global, multi-echelon supply chain.

The pilot identifies issues for exploration like product identifiers, interoperability, verification and notification, and so forth. But the table stakes are clear—life science companies need fast, across-the-board access to information on a digital collaboration platform, with the supply chain connectivity and reach to find and manage the data and provide viewing access for authorized users. A single, enveloping platform rationalizes this information administration task and enables reporting to facilitate collaboration. It will host needed systems for data acquisition, quality and regulatory submission management, electronic document management, incident and complaints management, and so forth.

Grouping all this data on a single platform also simplifies advanced analytics: AI and machine learning can more easily crunch both the archives and a continuous flow of new information to detect attribute clusters, uncover patterns, make predictions and prescribe actions to further the compliance effort.

The stakes are high. “Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond more rapidly when such products are found,” said FDA Commissioner Scott Gottlieb, M.D.

Editor’s Note: Interested in hearing from industry experts on transforming the patient experience? Register here for the 3DEXPERIENCE FORUM 2019, taking place May 13-16 at Caesars Palace, Las Vegas.

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