However, the legislation will establish a process where the US FDA and stakeholders have to better understand how and when to move to unit-level traceability, according to the committee.
The advancement of H.R. 1919, written by Rep. Bob Latta (R-OH), by voice vote ensures that the full House of Representatives will debate the bill at some point in this legislative session, according to consultant Dirk Rogers. This marks the first time since 1987 that a pharmaceutical track and trace bill has made it out of a Congressional committee, he said.
“Securing the supply chain through this bill will help ensure that counterfeit or stolen drugs do not enter the supply chain and harm patients,” said Health Subcommittee Chairman Joe Pitts (R-PA). “It will also ensure that overlapping red tape does not impose dramatic costs on patients in the form of higher prescription drug costs or potential drug shortages.”
House Bill’s Details
The bill lays out general requirements for how manufacturers, wholesalers and other stakeholders would have to take action to secure the supply chain. It also requires HHS (Department of Health and Human Services) Secretary, within two years of the enactment of the Safeguarding America’s Pharmaceuticals Act of 2013, to establish “one or more pilot projects in coordination with manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.”
In addition, drug manufacturers beginning in 2015 will have to provide a transaction history and a statement when moving products through the supply chain. No later than five years after enactment of the bill, “a manufacturer shall affix or imprint a prescription drug product identifier on each package and homogenous case of a prescription drug product intended to be introduced in a transaction.”
And no later than seven years after the enactment of the bill, or around 2020, wholesale drug distributors would only be allowed to distribute prescription drugs if the products are encoded with a product identifier, according to the bill.
Drug wholesalers, dispensers, manufacturers, re-packagers and third party-logistics providers can use secure electronic databases and identifiers to track and trace their products, though such databases and identifiers are not required by the House bill.
Unlike the House bill, a similar Senate discussion draft bill seeks to establish a lot-level electronic track-and-trace system for manufacturers and wholesalers. It remains to be seen how these differences between the bills will be reconciled. The Senate HELP (Health, Education, Labor & Pensions) Committee is expected to further discuss the bill on May 22.