Chairing Hearing, Warren Calls for Action to Address Drug Shortages, Guarantee Reliable, High Quality Care for Service Members and Their Families
Warren: “DoD relies on [imported drugs] and that gives potential adversaries the power to restrict DoD’s access which can result in harm to service members, their families, and our national security.”
Washington, D.C. — Today, U.S. Senator Elizabeth Warren (D-Mass.), chair of the Armed Services Subcommittee on Personnel, led a hearing on the Department of Defense’s (DoD) efforts to ensure service members are receiving safe, effective medicines. Senator Warren, in her opening statement, expressed concern that DoD’s overreliance on foreign drug manufacturers may pose risks to DoD’s pharmaceutical supply chains and affect quality of care for service members.
Senator Warren highlighted that almost half of the drugs on DoD’s operational medicines list, which contains drugs necessary for warfighting that are essential for meeting the medical needs of service members, are in shortage, and most of these drugs are generics. Senator Warren explained that many of these drugs – and their key ingredients – come from foreign manufacturers, a network over which DoD has less visibility and oversight.
The full text of Senator Warren’s opening remarks are available below:
Opening Statement
U.S. Senate Committee on Armed Services Subcommittee on Personnel
Tuesday, April 30, 2024
As Prepared for Delivery
This hearing will come to order.
Welcome to today’s hearing to receive testimony on the efforts of the Department of Defense to ensure service members’ access to prescription drugs that are safe, high quality, and effective.
We owe service members and their families the best health care possible. This is a morale issue, a recruiting issue, and ultimately, a national security issue.
DoD spends about $5 billion each year on pharmaceuticals. That’s about 2 percent of the entire U.S. commercial pharmaceutical market. To make these purchases, DoD must navigate many of the same challenges as civilian health systems.
For example, according to the FDA, almost half of the drugs on DoD’s operational medicines list – a list that contains drugs necessary for warfighting that are essential for meeting the medical needs of service members – are in shortage. This includes the blood thinner heparin, a common anesthesia drug called midazolam, and morphine for pain management. The impact of these drug shortages can be devastating. A shortage could mean using a drug with worse side effects. Or, it could mean having to use the second- or third-line treatment for an illness, rather than the most effective drug.
While there are many factors that can cause shortages – from spikes in demand to natural disasters to inspection failures – most drugs in shortage share a common feature: they are generics. That means they are no longer protected by patents, and they can be made by any manufacturer with approval from the FDA. Despite this, most generic drugs have very little competition. In fact, 40 percent of generic drugs sold in the U.S. have just one manufacturer.
Why? Because the profit margin for some generic drugs is so low that American manufacturers aren’t interested in making them. As a result, more of DoD’s generic drug supply is coming from foreign manufacturers who can produce drugs at even lower costs.
DoD’s reliance on overseas manufacturers is not limited to finished drug products. The ingredients used to make the medicines – called active pharmaceutical ingredients, or APIs – and the ingredients used to make APIs, known as key starting materials, or KSMs, are also increasingly sourced from abroad.
The COVID-19 pandemic exposed the risks we face by importing more and more of our commercial drug supply overall. DoD relies on those imported drugs and that gives potential adversaries the power to restrict DoD’s access which can result in harm to service members, their families, and our national security. In addition, the U.S. has less and less visibility into and oversight of foreign manufacturers and their manufacturing practices, especially in China.
These problems have concerned me for a long time. That’s why I partnered with Senator Rubio to secure language in the Fiscal Year 2023 NDAA requiring DoD to develop guidance for risk management of the Department’s pharmaceutical supply chain, report on supply chain vulnerabilities, and establish a working group to develop policies for allocating scarce pharmaceutical resources.
When a drug doesn’t work properly, it can have serious consequences for service members. Bloomberg reported last year that an outside lab tested tacrolimus, an immunosuppressant that’s used to treat soldiers who have lost limbs in combat. The results revealed that some generic versions of the drug might not work. Worse yet, they could cause kidney failure or seizures.
So, last summer, in accordance with Senator Rubio’s and my provision, DoD entered into a cooperative agreement with an independent lab to conduct a pilot study to test the quality of twelve finished drugs in the military drug supply. And in November, DoD revealed that 27 percent of the drugs on the FDA’s Essential Medicines List are at “Very High Risk” because they are either dependent on Chinese manufacturers using Chinese ingredients or were derived from unknown sources.
We are holding this hearing today to learn more about these challenges and to discuss DoD’s capacity to address them.
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