Reports: 'Track and trace' may be part of PDUFA reauthorization

NEW YORK — Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.

Politico reported that the Food and Drug Administration and industry stakeholders were debating about what a track-and-trace system, designed to keep counterfeit drugs out of the supply chain, would look like. Industry leaders, represented by the Pharmaceutical Distribution Safety Alliance, proposed requiring individual serial numbers for each lot of drugs, which could be checked against a central database.

The news site reported that industry stakeholders would prefer a national system over a system of state-by-state pedigree laws, but the FDA was not satisfied with what it was reported to regard as a weaker tracking system.


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