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The Hill - Heed Warning Signs and Secure Our Prescription Drug Supply Chain Now


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By Sen. Richard Burr

There are many issues that impact the health and day-to-day lives of the American people in a very meaningful way. For many reasons, including but not limited to the lack of appeal among elected officials and the media, these issues do not get as much attention as other issues until something goes wrong. In the aftermath of a crisis and the congressional oversight that follows, legislation may prove well warranted. This scrutiny after the fact often reveals early warning signs that, had they been heeded, may have allowed us to prevent or mitigate the crisis in the first place.
Last year's meningitis outbreak is such an example. As the tragic events over the past year surrounding the outbreak have reminded us, patients deserve the peace of mind that the medicine they take will meet their needs. Patients expect the prescription drugs that they take to be safe and effective, and they and their doctors do not think to question the security or safety of the supply chain through which the drug traveled.

Yet, the Food and Drug Administration has repeatedly warned of counterfeit drugs making their way into our prescription drug supply chain, including cancer medicine. While so many aspects of our everyday lives have been improved through technological advances over the past generation, many Americans would probably be very surprised to learn that the last comprehensive effort to establish safeguards for our nation's prescription drug supply chain occurred 25 years ago with the passage of The Prescription Drug Marketing Act.

The FDA's recurrent warnings of counterfeit drugs making their way into our prescription drug supply chain are the early warning signs of a growing threat that could significantly compromise the health and well being of patients across our nation. Over the years, states have responded by putting new requirements in place, but the increasing patchwork of regulatory requirements is driving up costs at a time when we must lower healthcare costs as each sector must comply with increasing, and sometimes conflicting, requirements for prescription drugs moving between states.

The absence of a uniform, federal approach invites criminals to take advantage of the states with the lowest supply chain security requirements. The need to establish a strong, uniform prescription drug-tracing standard that reflects today's realities is clear. To that end, earlier this year Sen. Michael Bennet (D-Colo.) and I introduced the Drug Supply Chain Security Act and along with our colleagues on the Senate Health, Education, Labor, and Pensions Committee, have been working to advance legislation that establishes such a uniform system that would help ensure a secure and safer pharmaceutical drug supply chain.

This fall, Congress should take up and consider the Pharmaceutical Quality, Security, and Accountability Act. This bipartisan legislation includes provisions that respond to the compounding meningitis tragedy over the past year. It also includes provisions that will strengthen the safety, security, and accountability of our nation's pharmaceutical drug supply chain, from manufacturers all the way to dispensers. The bill requires trading partners to be authorized and to pass and receive information as part of their transactions, raises the wholesale distributor licensure standards, establishes licensure standards for third-party logistics providers, and requires suspect and illegitimate products to be appropriately handled.

Congress will have the opportunity to advance balanced legislation on behalf of our nation's patients that appropriately responds to the tragic events over the past year and proactively puts in place uniform, workable standards that will provide stakeholders with critical regulatory certainty and give patients renewed confidence in the safety and security of our nation's pharmaceutical drug supply chain. Most important, it is a chance for Congress to not only appropriately respond to a crisis that impacted patients across our nation, but also an opportunity to demonstrate the ability to heed the warning signs before the next crisis impacting patients unfolds.

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