FDA eyes blockchain as DSCSA pilot programme starts

The FDA has launched a new pilot programme to look at technology that can help it meet its commitment to implement a track-and-trace system for medicines by 2023.

The requirement laid out in the Drug Supply Chain Security Act (DSCSA) is for an electronic, interoperable track-and-trace system aimed at reducing diversion of medicines distributed domestically and keeping falsified drugs from entering the US supply chain.

“We’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain,” said FDA Commissioner Scott Gottlieb (pictured) in a statement that references blockchain on multiple occasions.

It’s interesting that the FDA figure that will work most closely with Gottlieb on the pilot programme is Frank Yiannis, a former Walmart food safety executive who has become a big supporter of blockchain in the last few years. Yiannas has taken on the FDA’s top food safety job, succeeding Stephen Ostroff who retired last month.

At Walmart, Yiannas implemented a mandatory blockchain-based farm-to-store traceability platform for the fruits and vegetables industry that is due to come into effect in September. After that date, produce without blockchain traceability won’t be able to be sold at Walmart stores in the US as well as overseas.

Gottlieb said Yiannis “will be working closely with me on ways for the FDA to facilitate the expansion of such methods…to further strengthen the US food supply,” and also suggested blockchain could also be used to enhance drug supply chain security.

“For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it,” he continued.

The aims are also to establish a more robust product verification to ensure that a drug product is legitimate and unaltered and to make sure that any party involved in handling drugs in the supply chain have the ability to spot and quarantine and investigate any suspect product. The federal Register notice announcing the start of the pilot is available here.

The start of the DSCSA pilot programme comes right after the EU’s own medicines verification system started operating on February 9. That isn’t a full track-and-trace system as envisaged by the DSCSA legislation, rather an ‘end-to-end’ approach that relies mainly in verifying medicines at the point they are dispensed to patients.

It’s been anticipated for some time that the DSCSA approach would follow a similar pattern, i.e. that unique identifier codes will be applied to medicine packs at the point of manufacturing that could then be scanned and verified as the pack moves through the supply chain, and pharma manufacturers are already adding serialized 2D barcodes to packs to meet an interim requirement.

Once the DSCSA is fully operational, data will have to be generated on the movement of medicines from manufacturer to dispenser, with the ability to share that data with supply chain partners and authorised bodies.

Adding blockchain into the system could enhance the security of the system as it would create an unchangeable, transparent ledger of all the transactions in the distribution chain, but could also add to the complexity of the implementation.

The pharma industry has already started its own testing of blockchain, with the Center for Supply Chain Studies (C4SCS) running its own studies and pilots to see how blockchain could be applied to the DSCSA in practice.

Eligible participants in the market can now apply to be part of the drug traceability pilot programme, which could help shape the final system due to be operational in 2023.