Clear Labels Act Stripped of Critical Drug Safety Provisions
核心洞察
The Clear Labels Act (搜索), which would show where a drug was manufactured on its label, is headed to a full Senate vote after two key provisions were removed.
Senators struck the requirement to print the FDA's unique facility identifier, a DUNS number, and extended compliance from one year to five.
Drug safety experts and former FDA inspectors say the revised bill's address-only requirement will be hard to trace and enforce.
The Clear Labels Act (搜索), introduced earlier this year by Sens. Rick Scott, R-Fla., and Kirsten Gillibrand, D-N.Y., is headed for a full Senate vote after lawmakers removed two provisions that drug safety experts considered central to the bill. The legislation would require drug labels to state where a medication was manufactured, information that has largely been withheld, including from Congress. Current generic labels often list only the packager or distributor, which can sit thousands of miles from the actual factory.
One removed provision would have required labels to carry the unique code the FDA uses to identify factories, a DUNS number, which would have let researchers and the public trace a generic drug and its active ingredients to specific facilities and, in some cases, find FDA inspection reports documenting contamination. The other change extended the compliance timeline from as early as one year after passage to five years. People familiar with the deliberations said lawmakers worried the requirements would raise drug prices and weaken national security by revealing where lifesaving medicines are made.
Under the updated language, labels need only include factory addresses, which ProPublica found can be inconsistent and hard to link to a single facility; in 69% of prescription drug labels, reporters located a manufacturer's DUNS number and could connect it directly to a facility, while address-only records required automated verification, geolocation and extensive manual review. Experts also flagged the bill's reference to a "place of business," which they said could allow manufacturers to list a headquarters or subsidiary address instead of an overseas plant. The revised bill passed the Senate Committee on Health, Education, Labor and Pensions in July with only Sen. Rand Paul, R-Ky., dissenting; no date has been set for the full Senate vote.
Source: ProPublica