HELP Committee passes federal track and trace bill

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 support track and trace

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:

• Product identifiers must be affixed to a product within 4 years of the law’s enactment

• Manufacturers may only distribute their products to authorized trading partners

• Within one year, manufacturers must have systems to identify counterfeit products

• National requirements must be established that pre-empt state laws

• New licensing requirements in effect for wholesalers

• FDA will publish draft guidance on track and trace requirements

• Regulators would need to request data from entities; no real-time databases

• Transaction history must be maintained for 6 years after the date of the transaction

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 nmilenkovich@mcdonaldhopkins.com.