New Congressional action by year-end on pharma track-and-trace looks doubtful

In a somewhat unusual move, the staffs of several Congressmen put together a draft “discussion document” of a revived bill for setting up a national wholesaler-licensure program, and the requirements of a national track-and-trace/e-pedigree law. These two items were part of the broader debate over the FDA Safety and Innovation Act, passed this summer, but after they had been deleted. Congressional staff efforts at that time had been matched by industry deliberations, as evidenced by the formation of the Pharmaceutical Distribution Security Alliance (PDSA) earlier in the year, and that group’s issuing of its own draft bill, called the RxTEC Act.

This week, PDSA issued a statement that it is “hopeful” as deliberations continue, saying that "This draft shows that any remaining differences among Members are defined and resolvable” and that ““We urge Congress to resolve any remaining issues so this must-pass legislation can become law by the end of this Congress.”

However, informal comments from many of the attendees—many of whom are members of PDSA--at this week’s HDMA Pharmaceutical Track and Trace Seminar (Arlington, VA; Nov. 12-14) were less optimistic. The biggest problem isn’t the details of the bill, but simply the few weeks remaining until this Congress ceases at the end of the year; when the 113th Congress reconvenes in late January, the legislative calendar will be wiped clean. But those details are also an issue: the bill suggests a system of enabling lot-level tracking (something that was a feature of the RxTEC Act) as an interim step to a full, item-level system, and proposes a deadline for implementation of the full-blown system if FDA hasn’t acted in the meantime. Virginia Herold, executive director of the California Board of Pharmacy, asserted that from that state’s point of view, the first phase is unnecessary: “Many of you [manufacturers] already do that,” she said, adding that “we need a real federal law.”

It’s not too often that an industry group agitates for new federal regulation, but in this case, manufacturers and distributors are dealing with the 2015 deadline of the California board, which requires an interoperable, item-level e-pedigree system. Manufacturers have been busy implementing item-level serialization systems, but that’s just a first step to a system that provides tracing data across the entire supply chain. At the same time, national drug-wholesaler licensure would serve to tighten some gaps in the supply chain—something that most industry participants would welcome.