S-3788-119
Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
Sponsored by Rick Scott (R-FL)
What it does
This bill would require labels on active pharmaceutical ingredients and finished drug products to identify the original manufacturer (and packer/distributor, if any), either printed directly on the label or accessible through electronic means. It would create civil monetary penalties of up to 25% of the value of a noncompliant drug lot, explicitly excluding criminal penalties, and would take effect five years after enactment for drugs manufactured after that date.
Who benefits
Consumers and pharmacists seeking to know the true source of drugs and active ingredients, particularly given concerns about ingredients sourced from overseas facilities. Domestic drug manufacturers who may benefit from increased transparency about foreign supply chains. Public health researchers and regulators tracking contamination or quality issues to their source.
Who is hurt
Drug manufacturers, packagers, and distributors who would bear compliance costs for relabeling, tracking, and verifying original-manufacturer information, particularly generic drug makers with complex multi-source supply chains. Companies risk civil penalties of up to 25% of a lot's value for noncompliance. Smaller manufacturers may face proportionally higher compliance burdens than large firms.
Supporters argue
Supporters argue that a large share of active pharmaceutical ingredients used in U.S. drugs are manufactured overseas, often in China and India, and that current labeling rules obscure this from consumers and providers. They contend that requiring original-manufacturer disclosure would let patients and pharmacists make informed choices and would help regulators and the public trace quality or contamination problems back to their true source, citing past incidents involving contaminated imported ingredients.
Opponents argue
Opponents argue that new labeling and recordkeeping requirements would impose significant compliance costs on manufacturers, particularly generic drug makers who source ingredients from multiple international suppliers, potentially raising drug prices or reducing supply chain flexibility. They contend that civil penalties of up to 25% of a lot's value are disproportionately severe for administrative labeling errors and could push some manufacturers to exit the U.S. market, reducing competition and availability.