Blockchain May Be Used in FDA Medical Reviews and Recalls

The Food and Drug Administration (FDA) may incorporate blockchain to improve drug and medical products reviews and recalls.

In a speech at the Office of the National Coordinator for Health IT Third Interoperability Forum, on August 22, principal deputy commissioner Dr. Amy Abernethy, said the FDA is looking to modernize the way health care providers, drug manufacturers, and regulatory agencies communicate.

Without going into details, Abernethy said the agency plans to roll out uses of artificial intelligence, APIs and blockchain in this modernization effort. Improved interoperability – how the agency handles and shares information – may affect the reviewal process for new medicines.

“I want FDA to get our own technical house in order so that tech can ‘snap in’ – we can be agile and efficient. We need to be able to have common interfaces with industry so we can pass data between our organizations, have collaborative review, etc,” Abernethy said.

“Traceability back to source allows for the ability to crosscheck, workflow solutions,” she said. In that sense, the immutable ledger that blockchain provides may be used to guarantee data quality that comes from a number of sources.

Abernethy also alluded to a communication system where regulators are provided with real-time information and data. This speeds up the reviewal process, because FDA agents will be able to exchange messages contemporaneously with medical manufacturers.

Additionally, improved surveillance of medical products will assist in “determining when something should be recalled or a product label should be adjusted,” she said.

With improved data flows, Abernethy said medicine can become more targeted and patient-oriented.

Abernethy also serves as the acting chief information officer of FDA. She ended by saying the system will be rolled out in a “month or two.”

Future, doctor photo via Shutterstock