In May 2013, the Senate’s Health, Education, Labor and Pensions (HELP) Committee passed a track and trace bill known as the Drug Supply Chain Security Act. The bill is a result of a widespread problem-counterfeit drug products entering the U.S. supply chain over the past several years.
Regulators have been attempting to create a trusted pedigree for drugs for some time, so that a drug may be “tracked” as it passes downstream the supply chain and “traced” back to its origins, if necessary.
Senators Michael Bennet (D-Colo.), Richard Burr (R-N.C.), Tom Harkin (D-Iowa), and Lamar Alexander (R-Tenn.) are key supporters of the bill. They believe that federal legislation would improve patient safety by replacing a current “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.”
Harkin added, “[e]nsuring the integrity and security of our prescription drug distribution system is critically important. To ensure consumers know that the medications they take are safe-not adulterated, counterfeit, or otherwise compromised, it is important to know where these drugs have been at every step of the way-from the manufacturer to the pharmacy.” Notably, several previous attempts at passing federal legislation have failed due to opposition.
Details of the bill
The bill moves from a lot-level tracing system to a unit-level tracing system over the next 10 years. If passed into law, the bill would require the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers, to exchange 1) transaction information, 2) transaction history, and 3) transaction statements, as applicable, whenever there is a change of ownership. It would also be a violation of law if any member of the supply chain accepts drugs without being provided the required transaction information. The proposal also requires FDA to maintain a database of wholesale distributors to be made available on FDA’s website so that appropriately licensed wholesalers may be identified.
Other highlights of the bill include:
Stakeholders provide feedback
Several stakeholders chimed in with remarks on the draft bill. Some commended the bipartisan commitment and touted that it would better protect patients and consumers by creating a single and uniform national solution to supply chain integrity concerns. The bill is being pushed for passage into law by the end of this summer.
Ned Milenkovich is a member at McDonald Hopkins, LLC and chairs its drug an pharmacy practice group. He is also vice-chairman of the Illinois State Board of Pharmacy. Ned can be reached at 312-642-1480 or at firstname.lastname@example.org.