Easing a burden, keeping patients safe

Pharmacies in Colorado fill 60 million prescriptions every single year. In North Carolina, they fill 90 million a year. The families who take these drugs in Colorado and North Carolina, and the tens of millions more across the country, expect their medicine to be safe. For years, we haven't been able to ensure the safety of the supply chain through which prescription drugs have traveled.

We've made tremendous advances in medicine and innovation that have led to lifesaving drugs, yet we have failed to adapt to a global, complex and growing pharmaceutical drug supply chain.

In the last decade, this lack of oversight has allowed certain actors to manipulate market dynamics for their advantage, which has created uncertainty in the pricing and availability of various medications. As a result, hospitals are bombarded with calls offering them drugs on the FDA's drug shortage list that are unavailable through their contracted wholesaler. On average, they are offered these drugs at prices 650 percent higher than their contracted prices and there is no verifiable way to determine if these pharmaceuticals are even safe.

Furthermore, the FDA's repeated warnings of counterfeit drugs making their way into our prescription drug supply chain are the early warning signs of a potential and growing threat that could significantly compromise or endanger the health and well-being of patients across our country.

Establishing a strong, uniform prescription drug tracing standard will not only help prevent criminals from taking advantage of the states with the lowest supply chain security requirements, but will also save unnecessary, burdensome compliance costs that can impede economic growth.

It is for these reasons that for the past two and a half years, we have worked with drug manufacturers, wholesalers, distributors, pharmacies, patients and consumers to determine how we can create a system that will restore confidence in the safety and security of our supply chain. After countless hours of meetings and negotiations, Congress passed the Drug Quality and Security Act that was signed into law and takes effect in January. Our bipartisan bill is the first to update and establish new safeguards within the pharmaceutical drug distribution supply chain in a quarter century.

Over the next decade, manufacturers, repackagers, wholesale distributors, and pharmacies will work together to establish an interoperable electronic, unit-level system that will provide greater accountability for those along the supply chain who handle the medicine we take and which we give our children. Establishing these uniform standards will allow stakeholders greater regulatory certainty and give doctors and patients the confidence they deserve. We'll be able to more quickly address many drug shortages and recalls. Everyone along the supply chain will know that these drugs have been properly handled and kept safe for patients.

This bill is a model of what can be accomplished through hard work and pragmatism in Congress. The bipartisan effort earned the support of business groups, consumer groups, and many others. Most importantly, it will provide the tools to appropriately respond in the event of a crisis that can affect patients across the country and hopefully save lives in the process.

Sen. Michael Bennet is a Democrat from Colorado. Sen. Richard Burr is a Republican from North Carolina.


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