Moreover, the right tracking standards can also help authorities identify potential fraud and abuse in federal health programs. As with any public health and safety effort, the impact on law enforcement must be one of the priority considerations in policy development.
Most importantly, EMD Serono’s experience with our track-and-trace system has convinced me that only unit level traceability advances the security of the commercial channels of drug distribution. Many of the currently proposed standards for a nationwide system fall short of our best effort.
I recognize that the prospects of building a unit level system can be daunting — in fact, EMD Serono faced that exact challenge not so long ago when even fewer technologies were available. However, given a reasonable amount of time and a relatively small investment, these challenges can be addressed and our communities can see the benefits of enhanced supply chain safety.
There is no doubt that a national track and trace standard is the best policy to enhance the security of our drug supply chain. Moreover, a national standard will help eliminate the unnecessary regulatory burden of compliance with 50 different state standards. However, a weakened national standard will not address the current and future threats to public health, and a legislative approach that fails to move us toward a unit level standard within a defined time frame is a missed opportunity to ensure product and patient safety. These threats are not hypothetical — they are very real for patients who could be harmed by adulterated and counterfeit products.
Earlier this year, FDA Center for Drug Evaluation and Research Director Janet Woodcock testified at a Congressional hearing that lot level traceability would help regulators reconstruct how an adulterated product entered the system but would do very little to stop these products before they end up in the hands of patients. These comments have been underscored by consumer advocates and experts alike, further reinforcing the simple truth that anything less than a unit level track and trace standard will fail to accomplish the central tenet of this effort: to preemptively identify and remove potentially counterfeit or adulterated medications before they become a danger to patients.
Congress must stand firm in ensuring our drug supply is sufficiently protected from counterfeiters and other criminals, and consumers must be able to take medications with the confidence that the product inside the package is undoubtedly genuine.
Our nation has never settled for second-best when it comes to the safety of its citizens, and I am confident that the end agreement on supply chain safety will include only the world-class standards that we all agree patients deserve.
James Hoyes is president of EMD Serono Inc., an affiliate of Merck KGaA.