House to pass bill setting nationwide rules for pharmaceutical distribution

By Pete Kasperowicz

The House next week is expected to approve legislation that would set up nationwide rules aimed at allowing pharmaceuticals to be traced from the manufacturer to shippers and repackagers to pharmacies.

The Safeguarding America’s Pharmaceuticals Act, H.R. 1919, is meant to strengthen the ability to trace counterfeit pharmaceuticals back to their source.

The sponsor of the bill, Rep. Bob Latta (R-Ohio), says the bill is needed at a time when there are more than four billion prescriptions filled each year, and stories about counterfeit drugs are on the rise. He noted that today, the safety of the supply chain is backed by a “patchwork” of state laws.

“When an individual takes a prescribed medication, they should have full confidence that the medication is real and will not impose harm,” he said this month after introducing his bill. “It is of utmost importance that we implement common-sense solutions to safeguard our distribution supply chain against counterfeits and improve security and integrity throughout the supply chain.”

The bipartisan bill, which is cosponsored by Rep. Jim Matheson (D-Utah), would require manufacturers, distributors and repackagers to set up a process for tracing pharmaceuticals. It would also require entities in the supply chain to assist with verification and notification activities when suspect or illegitimate drugs are discovered, and demand that these entities work only with registered or licensed groups.

And it would require the Food and Drug Administration (FDA) to report to Congress on pilot projects aimed at improving cooperation with stakeholders on traceability.

Latta has said that over the past year, the FDA has issued three different warnings about counterfeit drugs, including some meant for cancer patients.

The legislation will be considered under a suspension of the rules next week, a process normally reserved for noncontroversial bills. It will get shorter debate time on the floor and will need a two-thirds majority vote to pass.

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