Clear Labels Act loses key tracking provisions before Senate vote

The Clear Labels Act, a bipartisan bill introduced by Senators Rick Scott and Kirsten Gillibrand, has been altered ahead of a full Senate vote. The legislation, designed to require generic drug labels to display the specific manufacturing facility, had two critical provisions removed. The requirement for a unique facility identification code, known as a DUNS number, was struck from the bill, and the original one-year compliance timeline has been extended to five years.

The bill was prompted by a ProPublica investigation revealing that the United States continued importing generic drugs from foreign factories with identified quality and safety lapses, such as leaks, mould, and contaminated water. Currently, generic drug labels often list only the location of the packager or distributor, which may be thousands of miles away from the actual manufacturer. Under the revised legislation, labels will only be required to include factory addresses, which experts note can be inconsistent and difficult to trace to specific manufacturing facilities.

Critics argue that the removal of the DUNS number weakens the bill's ability to track drug origins and safety issues. The unique identifier would have allowed the public and researchers to more easily trace a generic drug to the factories where it was made and access FDA inspection reports. ProPublica used this identifier to develop its Rx Inspector tool, which allows consumers and doctors to look up where more than 40,000 generic drugs are made. Without the code, linking a drug to a particular facility becomes a complicated process requiring automated address verification and extensive manual review.

Sponsors of the bill cited the need for FDA rulemaking time and concerns over drug prices and national security as reasons for the changes. A representative for Senator Gillibrand’s office stated that the five-year delay is meant to give the FDA time for rulemaking and allow manufacturers to redesign their labels. However, former FDA inspector Peter Baker argued that the timeline was unnecessary, describing the change as a simple label update that could have been implemented within a year.

Uncertainty remains regarding how the term “place of business” in the legislation will be interpreted. While sponsors say manufacturers must identify the factory where drugs were made, the legislation only mentions a “place of business.” This could potentially allow manufacturers to list the address for their headquarters or a subsidiary location in the United States rather than the actual overseas factory. Ohio State University professor John Gray warned that if this interpretation holds, the bill would be no different than current labelling practices.

The Association for Accessible Medicines, a generic drug lobbying group, previously opposed the bill, citing significant costs for limited returns. The group spent over $1 million on related lobbying efforts between January and July. The revised bill passed the Senate Committee on Health, Education, Labor and Pensions in July, with only Senator Rand Paul dissenting. A full Senate floor vote is anticipated, though a specific date has not yet been scheduled.