Senators Michael Bennet (D-Colo.), Richard Burr (R-N.C.), along with the Chairman and Ranking Member of the Senate Health, Education, Labor and Pensions Committee Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.), unveiled on April 19 a bipartisan plan to strengthen and improve nation’s drug distribution supply chain.
The Senators released a discussion draft of a bill that would improve patient safety by replacing “today’s patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country,” according to a news release issued by the senators.
“It is important that Americans be able to walk into one of 60,000 drugstores and pharmacies nationwide without having to question the safety of the medicines they buy,” said Alexander, HELP Committee ranking member. “This draft legislation will help us improve the safety and security of our medicines, by tracking them from the instant they’re manufactured to the moment you pick them up at the local drugstore.”
This plan would move from a lot-level tracing system to a unit-level tracing system over the course of a decade. It would require the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to pass transaction information, transaction history, and transaction statements, as applicable, when there is a change of ownership. Additionally, no one in the supply chain would be allowed to accept drugs if this information is not provided as part of a transaction.
This proposal also strengthens licensure requirements for wholesale distributors and requires FDA to keep a database of wholesale distributors that will be available to the public on the FDA website. This empowers both consumers and members of the pharmaceutical distribution supply chain to identify appropriately licensed wholesalers.
This legislation does not deal with safety issues at compounding pharmacies. The HELP Committee expects to release draft legislation on compounding sometime this week.
"Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves,” Bennet said. “In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death. This draft bill would put steps in place to prevent and reduce those problems and help ensure our drug supply is safe.”
“The American people deserve the peace of mind to know that the medicines they take are safe and effective,” Burr said. “This draft legislation establishes a uniform, national drug traceability system that improves the security and safety of our pharmaceutical supply chain for consumers.”
Chairman Harkin, Ranking Member Alexander, and Senators Bennet and Burr are requesting stakeholders to provide feedback, including their level of support for the overall proposal, any comments regarding the feasibility of this framework and any technical feedback to help improve the draft bill.
[See also: HHS convenes patient safety workgroup.]