A drug-origin bill loses the identifier that made its labels traceable

The Clear Labels Act was supposed to let patients and doctors identify the factory behind a generic medicine. Its strongest mechanism was a DUNS number: a unique facility identifier that can connect a label to FDA inspection reports documenting contamination or other failures. Senators removed that requirement and extended implementation from as little as one year to five years.

Addresses are a poor substitute. Multiple factories can share an Indian address, spellings vary, and labels may describe only a packager or distributor. ProPublica could directly connect 69% of the labels in its Rx Inspector database to a factory when a DUNS number was present; address-only records required geolocation and extensive manual reconciliation. The revised bill also uses “place of business,” language experts fear could permit a headquarters or importer address instead of the manufacturing site. Sponsors say the FDA will prevent that reading.

Supporters of the changes cite label costs, rulemaking time and national-security concerns about publishing the locations of critical-drug factories. A generic-drug trade group said the original requirements imposed significant cost for limited return and spent more than $1mn lobbying on generics and health bills, including this one, from January through July. The group did not answer ProPublica’s latest questions.

The underlying safety problem remains: US imports continued from foreign plants where inspectors found leaks, mould and contaminated water, and medicines from those facilities were associated with thousands of adverse-event reports. The committee approved the diluted bill with only Rand Paul dissenting; no full Senate vote is scheduled. It may produce more text on a label without producing a reliably queryable supply chain.