The bill introduced today builds on a yearlong effort to find consensus and incorporates feedback from stakeholders that the senators sought after releasing a draft of the proposal last month. If passed, it 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.
“It doesn’t make much sense to me or to anyone back in Colorado that right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills – information that could mean the difference between life and death for someone,” Bennet said. “With the record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug stores, it is clear that we must take steps to restore confidence to our nation’s families that our drug supply is safe. This bill will help establish a track-and-trace system that will ensure we can get bad drugs off the shelves as soon as they are discovered.”
“Securing our nation’s drug supply chain is critical to the health and safety of the American people,” said Senator Burr. “The American people deserve the peace of mind to know that the medicines they take are safe and effective. This bill establishes a uniform system that improves the security and safety of drugs for consumers.”
“To ensure the safety and integrity of prescription drugs, it is critical that we know where those drugs go once they leave the manufacturer. When Americans take medicine prescribed by their doctor, they should never have to worry that it is counterfeit or has been adulterated or compromised in any way,” said HELP Chairman Tom Harkin. “I am pleased that the HELP Committee has worked in a collaborative, bipartisan fashion to strengthen our ability to trace drugs through the supply chain, and I hope that we can advance this legislation so doctors, pharmacists, and consumers can know exactly where their prescription medications have been and if there is a problem with a drug, it can be quickly found and taken out of the supply chain.”
“This bill creates a new system for tracking drugs from the instant they leave the manufacturer to the moment you pick them up at the local drugstore. This will help protect consumers and families by improving the safety and security of our medicines in the United States,” Alexander said.
The Drug Supply Chain Security Act would transition the current system to a unit-level tracing system over the course of a decade. It requires the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to pass along transaction information, history, and 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 the change of ownership.
This bill establishes a workable pathway to unit-level tracing in a decade. Over the course of seven years, the major sectors of the pharmaceutical supply chain, such as manufacturers, repackagers, wholesale distributors, and dispensers will all be passing and holding onto transaction information and history, as applicable, for each drug product. Within that time, the Food and Drug Administration will publish guidance for the drug supply chain on uniform standards to make an interoperable, electronic drug tracing system, and conduct a small business dispenser assessment to look at the feasibility of this system. The bill also requires the FDA to conduct pilot projects on unit-level tracing as well as hold public meetings to ensure broad stakeholder input on a workable interoperable, electronic unit-level system within a decade.
The proposed bill also strengthens licensure requirements for wholesale distributors and requires FDA to keep a database of wholesalers that will be available to the public through the FDA’s website. This empowers both consumers and members of the pharmaceutical distribution supply chain to identify appropriately licensed wholesalers.
Senators Bennet and Burr have worked together for over a year to create a track-and-trace system that will help secure the nation’s drug supply. The two lawmakers secured language in the Senate FDA user fee bill last year to allow for continued discussions on efforts to protect the supply chain of pharmaceutical drugs. This bill is a result of those efforts to establish a national drug traceability system.The HELP Committee is expected to consider this bill and a bill to address safety issues at compounding pharmacies at a meeting next week.
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