HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204

November 17, 2013

By Jessica A. Ritsick & William T. Koustas

At this year’s Health Care Distribution Management Association (HDMA) annual track-and-trace conference, most minds were focused on one thing: the potential passage of H.R. 3204, the Drug Quality and Security Act, which would mandate a uniform, national, interoperable electronic track-and-trace system.  We’ve been following the evolution of this bill, which has seen more definitive traction in Congress in the past year than it has in the 25+ years since the passage of the Prescription Drug Marketing Act (PDMA), which requires a drug pedigree system be put in place (see our previous posts here, here, here, and here.)  Luckily, we haven’t been holding our breath, and neither were the conference attendees, because when the conference closed on November 13, 2013, H.R. 3204 was taken up, yet again, by the Senate, only to be again delayed by an unrelated amendment from Senator David Vitter (R-LA).

The conference provided a thorough overview of what all players in the prescription drug supply chain could expect should the bill become law.  It also provided food for thought about potential hiccups in the law’s implementation over the next 10 years.  Unlike Congress, however, at HDMA, it seemed like everyone was on the same page.  The general tenor in the room was that a national track-and-trace system was welcomed.  Virginia Herold, Executive Director of the California Board of Pharmacy, expressed to the group that California found the bill satisfactory, although the 10 year timeline was longer than it preferred.  Connie Jung, Acting Associate Director of Policy and Communications for FDA’s Office of Drug Security, Integrity, and Recalls, also expressed satisfaction with the bill, but also acknowledged that the work was just getting started.  Dr. Jung conveyed to the group that FDA has been actively ramping up its efforts and looking ahead to the new track-and-trace world, and acknowledged that the Agency is not in this alone; working with other players in the game is both welcomed and necessary to success. 

With fingers crossed, attendees looked ahead to the future of track-and-trace.  Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states.  It is hoped that this bill will put everyone on a level playing field and reduce loopholes.  Moreover, once implemented, panelists expressed hope that the systems created under the bill could be leveraged in other prescription drug problem areas, such as with prescription pain medication abuse (e.g., pill mills, doctor shopping).  While many expressed that some of the deadlines in the bill might be unrealistic, there was general consensus that supply chain partners were ready to get to work making this long-held dream a reality.