The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it received in the US Congress. But that support was not earned without some hard negotiating, and several prominent but controversial provisions were dropped from the final iterations of the bill. Now some of the industry's most prominent voices are taking to the Washington press to argue that at least one of those provisions, pharmaceutical track and trace, needs to be reconsidered.
Track and trace is, to use plain parlance, the method employed to make sure regulators and companies can determine the authenticity, identity and whereabouts of a particular drug product. It is so named because, under an ideal system, regulators would be able to track where a product is going in the supply chain and trace where it has been.
But if track and trace has experienced broad support on its general merits, its details have been a source of serious debate.
During the 2012 debate over FDASIA, legislators ultimately dropped a track and trace provision from the bill at the last minute over at least three major concerns: who might pay for a system if it were to be required of manufacturers, the level of granularity required to be tracked (lot level or unit level), and what the system might look like (a real-time system or serialization with barcodes and databases).
Rather than risk the broad-based support that FDASIA enjoyed, proponents of track and trace decided to sideline the measure, leaving it to either be treated as a stand-alone bill or bundled up into another piece of healthcare legislation.
At the time of the provision being dropped from FDASIA, some in industry speculated that track and trace could find its way into the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), another huge piece of legislation passed in 2013 that provided new funding and authority for FDA to carry on its biodefense regulatory activities. Track and trace was not, however, among the bill's many provisions.
New Calls for Inclusion
For the Pharmaceutical Research and Manufacturers of America (PhRMA), Generic Pharmaceutical Association (GPhA) and the Healthcare Distribution Management Association (HDMA)-three unusual allies given their normally competing interests-continued delays in track and trace have only served to put the public in danger.
Writing in an opinion piece published in Politico, the trio points to the safety of cancer drugs as one area in which consumers have been harmed.
"Three times in the past year including just last month, the Food and Drug Administration (FDA) has issued warnings that counterfeit cancer drugs originating overseas infiltrated the US pharmaceutical supply chain, putting patients at risk," they wrote. "While the U.S. is fortunate to have one of the safest and strongest pharmaceutical supply chains in the world, incidents like these remind us of the vulnerability of the supply chain and the need to remain vigilant to safeguard the lifesaving and life-enhancing pharmaceuticals that benefit every American."
Those sentiments are ones shared by many in Congress. In the wake of similar counterfeiting concerns in 2012, Sen. Jay Rockefeller and Rep. Elijiah Cummings both put out a statement saying such measures were necessary to protect the pharmaceutical supply chain. And perhaps no other legislator has been as adamant about track and trace as Sen. Richard Burr (R-NC), who took to the Senate floor for nearly two hours in 2012 to lament Congress' lack of action on track and trace.
The Devil's in the Details
But what should such a system look like? The opinion piece is light on details, but nevertheless proposes a four-part framework by which they would measure a successful system:
- "Require that prescription drug products contain sophisticated technology able to determine the product's source and distribution history"
- "Provide immediate protection and develop a building block approach to allow for ongoing enhancements"
- "Provide FDA with the nationwide authority to keep the system safe from bad actors"
- "Ensure an efficient, cost-effective system applicable in all 50 states"
"Now is the time to pick up where the previous [FDASIA] effort left off," they continued.
The groups also repeatedly emphasized that a national solution is needed, saying that while counterfeiting incidents occur infrequently, "that they continue to happen and put patients at risk underscores the need for Congress to enact a comprehensive, uniform and national supply solution chain."
"The distribution of pharmaceutical products occurs nationwide and requires national levels of protection," they continued. "To allow tracing of prescription drugs in this supply chain to be regulated on a state-by-state basis creates chinks in the distribution chain that bad actors have exploited to gain entry to the system. This ad hoc system would result in a patchwork quilt and bring with it a wide variation in technologies and standards that will not adequately protect patients."
"The only effective safeguard … is a national solution," they concluded, "If Congress does not act soon, the expensive hodgepodge of state laws will continue, leaving consumers at a much higher risk."
The question, then, is how legislators might pick up the since-abandoned legislative effort. The Senate released a draft proposal in October 2012 that could provide the framework for such a system. But that still leaves open the question of whether the legislation would be treated as a stand-alone measure, or tacked on to a larger piece of healthcare legislation, such as the Animal Drug User Fee Act (ADUFA) or the Animal Generic DrugUser Fee Act (AGDUFA), both of which are currently under consideration by the House and Senate.
In the interim, FDA has indicated that it could move to institute additional requirements for pharmaceutical manufacturers on track and trace. In its 2013 guidance agenda for the Center for Drug Evaluation and Research (CDER), FDA said it plans to develop a guidance document on "Securing the Drug Supply Chain-Standards for Tracking and Tracing Prescription Drug Packages." It is at the time of this article's writing unclear what that guidance-a voluntary measure-might look like.