WASHINGTON — A bill designed to beef up the safety of the nation’s prescription drug supply is poised to pass Congress, but without a tracking system that public health advocates say is critical to weeding out counterfeit pharmaceuticals.
House and Senate lawmakers agreed late Monday on compromise legislation that helps supplement the Food and Drug Administration’s budget. The two chambers previously passed separate versions of the bill, which also increases safety inspections and penalties against drug counterfeiters.
Lawmakers dropped a Senate provision which would have created a national network for tracking drug shipments and preventing counterfeit and stolen drugs from entering the US supply chain. Pharmaceutical companies and regulators have argued over the cost and scope of the network for over a decade, though industry observers hoped this year’s must-pass FDA bill might provide a vehicle for a compromise.
The FDA and safety advocates have pushed for a system that would track each individual drug bottle through the supply chain using electronic barcodes or tags. Such systems are already used in countries like Belgium, Sweden, and Turkey.
But industry groups said tracking every individual unit could be too expensive and burdensome for manufacturers, suppliers, and health care professionals. Medicines typically pass from manufacturers to distributors to hospitals and pharmacies before reaching patients. Instead, drugmakers proposed a system that would track medicines at the lot level. But safety advocates said that approach wouldn’t be very useful, since each lot can contain tens of thousands of bottles.
The House is expected to vote on the compromise FDA legislation Wednesday afternoon. Lawmakers there previously passed the bill by an overwhelming 387-to-5 vote. A vote in the Senate is expected early next week.