FDA Pilot Program Will Test Blockchain To Help Curb Counterfeit Drugs

The FDA is exploring innovations that could help it track drugs, including blockchain, and it has a new pilot program to test them out. The agency revealed its pilot program in an announcement today, explaining that drug manufacturers, stakeholders, repackagers, and others can test the "emerging approaches" to verifying and tracing prescription drugs in the United States.

The pilot program intends to increase the accountability for drugs coming into the US, this ultimately helping ensure the high level of quality and safety required. Of particular concern are counterfeit drugs, which may be manufactured overseas and then entered into the US supply chain.

Under the Drug Supply Chain Security Act, an interoperable track-and-trace system for monitoring drugs will go into effect in 2023. Eligible participants in the market can apply to be part of the FDA's new pilot program, which will help shape the creation of that electronic tracing system. Different technologies will be piloted by these companies, though not all of them will ultimately be part of the final system.

While discussing the new pilot program, FDA Commissioner Scott Gottlieb, MD, revealed that blockchain is one such potential technology. According to Gottlieb:

We're invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain. To advance these efforts, the FDA recently recruited Frank Yiannas, an expert on the use of traceability technologies in global food supply chains. He'll be working closely with me on ways for the FDA to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the U.S. food supply.