Surprise! No federal law on track-and-trace or e-pedigree made it out of Congress before the summer recess

It’s hard not to feel a sense of foreboding about the prospects for federal legislation on pharma track-and-trace, the years-long effort to establish uniform national standards for monitoring the distribution of drugs from manufacturer to dispenser. In May and June, as Congress sped forward on the Pharmaceutical Quality, Security and Accountability Act (S.959) and the Safeguarding America's Pharmaceuticals Act (H.R. 1919), there was talk of having a bill ready for White House signing before the August recess, which began Aug. 2. But a major difference between the two—whether to include legislation pertaining to compounded pharmaceuticals—now appears to be a major stumbling block. In the Senate, the track-and-trace legislation got bolted tougher with a compounding pharmaceutical bill. The House version did not, and two pharmacy bills in the House Energy and Commerce committee showed some signs of being hung up over a generally Republican stance of leaving authority mostly in state hands, versus a Democratic stance of expanding FDA authority.

Manufacturers and wholesalers, who came together (with others) in 2012 to form the Pharmaceutical Distribution Security Alliance, very much want federal legislation in place—sooner rather than later—to forestall the implementation of the California e-pedigree law, which is set to go into force beginning in January 2015. A manufacturer who has done nothing to add serial numbers to pharmaceutical packages, and set up an IT system to track where those packages have gone into the supply chain, now has 17 months to get ready for that requirement—unless a federal law pre-empts the California mandate (which, ironically, California’s own law allows the federal law to do). Wholesalers have an additional year to get their systems in place—and most of them have been clear that a) they don’t want to be distributing “California-only” packages and b) they will not want excessive amounts of pre-mandate, untrackable inventory in their distribution centers come January 2016.

In mid-July, a House E&C subcommittee held a hearing on drug compounding, in the context of the VALID Compounding Act (HR 2186), the Senate bill, and a draft bill from Rep Mason Griffith (R-VA), called the Compounding Clarity Act. While testimony from FDA, the Am. Soc. of Health-System Pharmacists (ASHP) and the National Assn. of State Boards of Pharmacy (NABP) was strongly for expanded federal oversight, testimony from the National Community Pharmacists Assn. (NCPA) and the International Academy of Compounding Pharmacists (IACP) was just as strongly for state-level control. All participants, meanwhile, struggled with how to define a difference between “traditional compounding” (a pharmacist making a single dose for an identified patient and used more or less as soon as supplied) and “nontraditional compounding”—making dosages in bulk, not for named patients: the kind of production that has been implicated in the NECC meningitis scandal of the past year, resulting in at least 63 deaths.

One of the interesting—and worrisome—revelations of the past few months of study of this problem is that hospitals now routinely depend on so-called “outsourced suppliers” for significant quantities of compounded products, especially anesthetics. An HHS OIG report from April found that 92% of surveyed hospitals used outsourced compounded sterile products (CSPs)—and while they reported few problems with them, it is likely that federal or state oversight of those suppliers is spotty.

Back to track and trace

The NECC compounding scandal, arguably the worst quality breakdown since the heparin scandal of 2008, clearly needs to be addressed, but at this point threatens to derail the near-30-year-long effort for a federal track-and-trace system. It’s impossible to predict what will happen next. The compounding legislation could be severed from the track-and-trace legislation; the House could pass a compounding bill, and then the House and Senate conferees could try to reconcile their differing bills; or track-and-trace could be left on the side of the road (again). Most leading manufacturers are already starting some activity in producing serialized product on their packaging lines, but the broader goal of tracking those products through distribution is still at a very early stage. Meanwhile, alternative tracking systems (but involving serialized products) are moving ahead in much of Europe, China and several other countries. Fast forward a couple years, and it begins to look as if the richest pharmaceutical market in the world—the US—will also have the one of the more porous supply chains for counterfeit or diverted drugs.