WASHINGTON, DC – U.S. Senator Gary Peters (D-MI), Chairman of the Senate Homeland Security and Governmental Affairs Committee, released a new report detailing the results of his investigation into continued shortages of critical medications. The report found that shortages of drugs are on the rise due to economic drivers, insufficient visibility into supply chains, increased demand, and our nation’s continued overreliance on foreign suppliers for many of the raw materials used to manufacture critical drugs. Peters’ investigation showed that drug shortages, as well as a lack of transparency into our pharmaceutical supply chains, present an ongoing national security risk and have made it harder for health care professionals to treat patients. The findings build on a 2019 report Peters released that identified serious health and national security risks created by drug shortages and an overdependence on foreign pharmaceutical supply chains. The investigative report released today makes several recommendations that will help our nation address long-standing shortages of critical medications. Following the release of the report, Peters convened a full committee hearing to discuss its findings and recommendations, the impact that drug shortages have had on Americans, and additional actions that lawmakers can take to solve this problem.

“While some shortages may only be an inconvenience, others can have devastating impacts on patient care,” said Peters during his opening statement at today’s hearing. “There are a number of factors that contribute to drug shortages, including economic drivers that lead to a lack of manufacturers willing to enter or remain in the market or invest in quality manufacturing systems, insufficient visibility into the entire supply chain for critical medications, and an overreliance on foreign and geographically concentrated sources for the materials needed to make these drugs.”

“In 2019, I released a report identifying many of these national security risks, and how they contributed to drug shortages and in some cases, price hikes,” Peters continued. “Today, I am releasing a new report that builds on those previous findings, and identifies additional recommendations to strengthen domestic manufacturing of critical drugs and limit the disruptions caused by shortages and supply chain issues.”

For text of Peters’ opening remarks from the hearing, as prepared for delivery,

READ THE FULL REPORT: “Short Supply: The Health and National Security Risks of Drug Shortages”

READ THE EXECUTIVE SUMMARY

The report’s key findings include:

    Drug shortages are increasing, lasting longer, and impacting patient care;

    Overreliance on foreign and geographically concentrated sources for critical drugs and their key materials, and limited domestic manufacturing capabilities create health and national security risks;

    The FDA still lacks critical information that could help mitigate shortages; and

    Industry and the federal government lack end-to-end visibility into the pharmaceutical supply chain and efforts to map supply chains are not sufficiently coordinated.

The report’s key recommendations include:

    Invest in domestic advanced manufacturing capabilities for critical generic drug products regularly in shortage;

    Conduct regular interagency medical supply chain risk assessments;

    Require manufacturers of life-supporting and life-sustaining drug products to report increased demand and export restrictions to the FDA; and

    The FDA should take steps to ensure its supply chain data can be used to monitor supply chain vulnerabilities and conduct predictive modeling.  

While the COVID-19 pandemic highlighted vulnerabilities in our nation’s medical supply chains, drug shortages are a longstanding problem and for decades, hospitals and health care providers have regularly experienced shortages of medications that are used to provide critical care and treat serious diseases, like cancer. Additionally, emergency room care, surgical procedures, and other critical medical care often requires injectable sterile drugs that remain in short supply. Peters’ report found that several factors contribute to these shortages, including economic factors like a lack of incentives that have led manufacturers to exit the market, manufacturing and quality problems, a lack visibility into where drugs and raw materials are manufactured, and an overreliance on foreign suppliers – including those from China and India – for critical materials needed to manufacture medications. The report also found that there are a limited number of suppliers for certain critical medications and drugs. In some instances, if a manufacturer that supplies a large portion of a certain medication were to shut down due to natural disasters or other events, it could greatly impact the availability of that drug. Peters’ investigation also found that the federal government, including the Food and Drug Administration, has not effectively obtained or used existing data to predict ongoing and potential drug shortages. The report makes several recommendations to ensure that our nation is better prepared to prevent potentially harmful shortages of critical medications.

At today’s hearing, Peters asked expert witnesses to comment on the findings and recommendations of the report. The witnesses emphasized how a lack of transparency into our medical supply chains has impacted health care providers and pharmacists who are dealing with drug shortages in real time. Experts also discussed how a lack of data on supply chains has limited health care providers’ ability to plan for and respond to shortages. Peters also asked experts to further explain how our reliance on foreign manufacturers and a limited number of sources for critical drugs and their raw materials creates national security risks.