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.
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