Christopher R. Smith, Senior Counsel in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the firm’s Washington, DC, office, authored an article in Bloomberg Law US Law Week, titled “INSIGHT: Drug Supply Chain Security Act Projects Create Opportunities, Pose Questions.”
Following is an excerpt:
The FDA recently posted 20 pilot projects pursuant to requirements under the Drug Supply Chain Security Act.
Congress enacted the DSCSA in 2013. The act was crafted in response to the danger to patient safety of counterfeit drugs entering the U.S. prescription drug supply chain. Congress designed the law to require drug supply chain stakeholders to trace prescription drugs, in a secure manner, from the manufacturer down to the dispenser of the drug.
When fully implemented, the law will require drug supply chain stakeholders to securely exchange transactional data regarding prescription drugs through an electronic interoperable data exchange.
The pilot projects are designed to test concepts for purposes of developing the 2023 electronic interoperable data exchange under the DSCSA. While there is no guarantee that any particular project will dictate the future, if we channel our inner Carnac the Magnificent, we will see several serialization challenges facing industry moving forward, as well as a strong industry-driven theme of blockchain leading toward 2023.