The bill, known as H.R. 1919, would require companies to keep track of the drugs filtering through their chain of wholesalers, distributors and packagers, as well as create notification rules for some drugs considered unsuitable for distribution. But the legislation stops short of requiring unit-level drug tracking, which is what the FDA requested in the past, and is the reason a number of House Democrats took issue with the bill.
Such a tracking system would not be implemented until 2027, which is when the bill mandates that the FDA propose regulations for such a lot-level system.
The bill also would require the FDA to establish a licensing program for certain third parties that provide outsourced logistical services to support pharma manufacturers, wholesalers and dispensers. The licensing program would also be financed by industry fees spent by the FDA.
The non-partisan US CBO (Congressional Budget Office) estimates that the bill would increase federal revenue by $24M between 2015 and 2023. But according to consultant Dirk Rodgers, the CBO’s estimations rely on a 2008 report by Accenture, and updated by National Association of Chain Drug Stores in 2011, called, “Current Status of Safety of the U.S. Prescription Drug Distribution System” to determine costs to individual retail pharmacies.
“The problem with using the Accenture/NACDS cost projects for implementing H.R. 1919 at the pharmacy level is that the bill would impose a lot-based pedigree at least through 2027, and after that it might turn into the kind of package-level track & trace system envisioned by that 2008 report,” Rodgers wrote. “I should note that few people agreed with Accenture’s calculations at the time.”
Differences with Senate Bill
The House will still have to reconcile its bill with a similar bill making its way through the Senate. That bill would require a lot-level drug tracking system that would require serialization for supply chain companies from between four and seven years after the legislation is enacted.
Both bills would also take precedence over California’s plans to implement a statewide track-and-trace system by 2015, thus setting back those plans by a few years.
The Senate bill would also create penalties for companies that fail to comply with the lot-level tracking requirements.