Drug shortages are a national security threat.

The COVID-19 pandemic laid bare the longstanding vulnerabilities within the U.S. pharmaceutical supply chain. Just-in-time manufacturing practices, overreliance on both foreign and geographically concentrated sources for critical drug products, and insufficient supply chain visibility, among many other challenges, have resulted in widespread shortages of critical drug products over recent decades. Shortages of critical medical products, which are commonly used in hospital emergency rooms and outpatient settings, worsened throughout the COVID-19 pandemic as global demand increased and countries began initiating export bans to keep needed products.

The subsequent surge in respiratory viruses in the fall and winter of 2022, with a confluence of COVID-19, RSV, and influenza cases, resulted in increased demand for prescription and over-the- counter medications, further stressing the pharmaceutical supply chain. In addition, staffing shortages and transportation delays continue to present challenges. Since Senator Peters released his 2019 report on drug shortages, the number of active drug shortages has generally continued to rise. 1 As shown in Figure 1, injectable drug products, which can include supportive care medications (like IV saline), sedatives (such as propofol), and chemotherapy drugs, are more than twice as likely to experience shortages compared to other dosage forms, such as oral tablets or topical products. 2 However, recent shortages of basic over- the-counter medications, like pediatric Tylenol and Motrin used to treat children’s flu and fever, have also spiked due to increased demand, leaving many shelves bare and pharmacies limiting sales.

Throughout the past few decades, drug manufacturers have gradually shifted facilities overseas as foreign governments have offered tax incentives, fewer regulations, and other financial and logistical incentives. While innovations in technology and transportation have resulted in a globalized pharmaceutical supply chain with increased efficiencies, such developments also pose increased risks, such as cybersecurity threats, regulatory challenges, and an overreliance on foreign sources.

According to the American Society of Health-System Pharmacists (ASHP), which collects the most robust data on drug shortages, a drug remains in shortage for an average of nearly 1.5 years (537 days. However, certain therapeutic categories may experience shortages for longer periods of time. For example, hormonal agents, which can help slow the onset of certain health conditions, have an average shortage duration of 1201 days; local anesthetics, 878 days; chemotherapy agents, 621 days; and cardiology agents, 618 days.? Over fifteen basic critical care drugs-the majority of which are injectable products have remained in shortage for over a decade. See Figure 2.

Of these products, nearly one third are antimicrobial agents, such as antibiotics, used to prevent and treat bacterial infections. 10 In 2020, the White House directed the FDA to develop a list of "essential medicines, medical countermeasures, and critical inputs" that are "medically necessary to have available at all times."11 The Essential Medicines list that the FDA created in response to this directive includes drugs that, according to FDA, are most needed for patients in U.S. acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions. 12 Nearly half of the antimicrobial agents listed on the FDA's Essential Medicines list created in response to this directive, "have no domestic API manufacturing.”

The Department of Defense (DOD) has acknowledged that it is "wholly dependent" on the commercial market for pharmaceutical products to ensure the "health, safety, and wellbeing of DOD personnel."14 As Christopher Priest, then Acting Deputy Assistant Director for Health Care Operations and Tricare for the Defense Health Agency, stated in testimony before the U.S.-China Economic and Security Review Commission in 2019, "the national security risks of increased Chinese dominance of the global API market cannot be overstated . . . [should China decide to limit or restrict the delivery of APIs to the United States, it would have a debilitating effect on U.S. domestic production and could result in severe shortages of pharmaceuticals for both domestic and military uses."IS A 2021 Department of Homeland Security (DHS) Key Threats Assessment found that medical products "sourced from abroad or that depend on global supply chains will remain especially vulnerable to disruptions due to sustained demand, foreign government actions to secure supplies of such goods for their country's use, and the length of time required to reconstitute these production capabilities elsewhere."