The tracking of individual drug units looks to be coming to the U.S, just not for 15 years or more.
A bill being pushed by U.S. House Republicans would start the process for tracking lots of drug units through the supply chain but would not allow the FDA to even consider tracking on the unit level until 2017, Reuters reports. A bill in the Senate, where Democrats hold sway, would phase in unit tracking much sooner, which the FDA has asked for. It is these extreme differences in point of view that kept legislation from being included in the FDA funding bill last year.
Critics said the very long wait to look at unit tracking might keep it from ever happening. In a letter to subcommittee leaders, the Pew Charitable Trusts said, "This prolonged timeline will eradicate momentum in the supply chain towards unit-level traceability." The foundation has been among supporters of an electronic system, which would allow the industry and the FDA to track individual units through the supply chain.
Other countries, including China, are looking at moving to systems that can keep track of drugs and help regulators and the industry thwart counterfeiters. Calls to implement a system are revived every time regulators report more cases of essential counterfeit drugs being discovered in the U.S.
The industry actually wants to get something on the books that would preempt a California law that would require unit tracking starting in 2015. Last month, officials with three of the leading drug and delivery associations wrote an op-ed piece for Politico calling for a system that would use technology to "determine the product's source and distribution history; provide "immediate protection" as well as use a "building block approach" for enhancements; give the FDA authority for the system and apply the "efficient, cost-effective system" to all 50 states.
- read the Reuters story
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