The idea of creating a national track and trace system for the pharmaceutical supply chain is apparently alive and kicking around Congress. It is a concept that when we last checked was inert on a backroom floor after being surgically removed last summer during negotiations over the FDA reauthorization bill.
Sen. Michael Bennet, a Democrat from Colorado, on Wednesday told The Hill that work is progressing on the idea, in the form of a draft bill, kind of a trial balloon.
According to the 117-page draft, the FDA and the industry would work to arrive at a system in which each drug package has a unique identifier that could be used to track it down if there are any questions about quality, adverse affects or counterfeiting. The drugmakers would have databases that track all of the products. Along each hand-off in the supply chain, whoever has custody of product would be required to establish the supply chain history, in paper or electronic form.
The FDA has been pushing for a system that would allow it to easily find medications that need to be recalled or tracked down for any reason and that could be verified to fight counterfeits like the fake Avastin that showed up this year in the U.S. But the industry has fought having individual identifiers and the investment that would be required of shippers and drugmakers to scan and track single packages of drugs. Different parts of the industry have leaned more toward a system that would initially track lots of drugs. The idea was that eventually a more sophisticated system could be developed. The industry also would like something that would short-circuit state efforts that may not be uniform. California has passed a law to take affect in 2015 that will require unique identifiers.
Unable to agree on details between what the FDA was seeking and what the industry was willing to sign off on, the plan to finally create a nationwide system got left on the negotiating floor during negotiations over the FDA reauthorization legislation. But now it is back, maybe prompted by the meningitis outbreak tied to tainted drugs from New England Compounding Center.
As Allan Coukell, director of the medical programs at the Pew Health Group, tells Pharmalot, "In general, it establishes an interim national system that would result in tracking of drugs at the lot-level. It also lays out a potential path to a permanent unit-level tracking system. And it establishes a framework that would ensure uniform licensure standards for pharmaceutical wholesalers."