This month, Congress is expected to send a final Prescription Drug User Fee Act reauthorization law to the president’s desk. In addition to implementing new user fee agreements for drugs and devices, this legislation will include a number of other critical programs aimed at improving the capabilities of the Food and Drug Administration to bring innovative, safe and effective treatment options to patients nationwide.
The PDUFA reauthorization process has been a notable and unique example of bipartisanship in the halls of Congress, with Republicans and Democrats negotiating in good faith to produce legislation that is widely supported on both sides of the aisle.
Nonetheless, final agreement on the standards for a nationwide track and trace system for pharmaceutical products, one of the most complex and promising issues in these discussions, is still pending. This issue is critically important to the safety of America’s pharmaceutical supply chain and we must ensure that the final agreement will strike the right balance between efficacy and efficiency. Indeed, the one thing that we can all agree on is that we should not compromise public health and safety.
As the president of a company that is currently utilizing a track and trace system for some of our products, I believe there are core elements of a supply chain safety plan that must be included in a nationwide standard in order to allow us to follow products from the manufacturing line through to the pharmacy. EMD Serono is the U.S. affiliate of an international biopharmaceuticals company that manufacturers products to treat conditions such as multiple sclerosis, HIV-related conditions and infertility. Due to the specific nature of our product portfolio, we determined that the integrity of these products is a critical issue for the patients who rely on them. As such, we took steps to protect select products against illegitimate distribution, reimbursement fraud and possible counterfeiting.
EMD Serono took steps to increase the likelihood that our products are reaching our patients rather than diverters and/or criminals by developing an innovative track and trace system with unit level traceability. By tracking our products at the unit level, we are able to know where a box of product is at any step in the distribution process, from the manufacturing plant to the wholesaler and the pharmacy. We built a system that functions in near real time using existing claims processing technology, allowing us to immediately identify an illegitimate product coming into the pipeline, whether it is at international customs or your local pharmacy. The program is strong — since we implemented a unit level tracking system the risk of diverted product, counterfeit product and fraudulent pharmacy claims has been reduced significantly.
Not only are the benefits of unit level tracking apparent to our company and our patients, they are also evident in the community at large. This system gives us the ability to assist local, state and federal law enforcement in the interdiction of counterfeit and adulterated drugs, helping pinpoint their exact origin and chain of custody. Our employees have even testified at criminal proceedings on illegitimate products’ path of distribution.
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.