Rising Drug Shortages Pose National Security Risk

A new report released by the United States Senate Committee on Homeland Security and Governmental Affairs says drug shortages have increased by 30% from 2021 to 2022, posing a serious national security risk.

As the nationwide drug shortage continues, many Americans are having difficulty finding the medications they need. For example, the ADHD drug, Adderall, continues to be in short supply, as well as albuterol — a medication used to control asthma. Moreover, even over-the-counter drugs used to treat children’s cold symptoms are becoming scarce.

But those aren’t the only drugs in short supply. For instance, hospitals are currently struggling to find enough injectable sterile saline products and other critical care drugs — including medications used to treat cancer.

These ongoing drug shortages have impacted hospitals, healthcare providers, and people who rely on specific drugs for their health and wellbeing.

Why is the U.S. experiencing drug shortages?

In 2019, U.S. Senator Gary Peters released a report examining U.S. drug shortages, indicating that nearly 80% of manufacturing facilities that produce active pharmaceutical ingredients (API) for medications — such as sterile injectable products and generic drugs — are located outside the U.S.

The report concluded that U.S. over reliance on foreign sources for these drugs posed a national security risk that could have devastating impacts on hospitals, healthcare providers, and patients in the event of a crisis.

Shortly after Senator Peters released the report, the COVID-19 pandemic hit, creating a crisis that placed even more strain on the U.S. medical supply chain. The pandemic also exposed just how dependent the U.S. is on China and other countries to supply the APIs required to make many medications.

In a new report released on March 22 examining the drug shortage situation in more detail found several concerning trends that underscore the need for urgent government action.

First, the report indicates that between 2021 and 2022, new drug shortages increased by almost 30%. Moreover, there were 295 active drug shortages at the end of 2022 — a five-year high.

In addition, while medication shortages typically last around 1.5 years, current data indicates that more than 15 critical drug products have been in short supply for over a decade.

Secondly, the report says the U.S. still relies on foreign sources for critical drugs and ingredients to manufacture medications. For example, the Administration for Strategic Preparedness and Response (ASPR) says the number of Chinese-based API manufacturers registered with the FDA increased from 188 in 2010 to 445 in 2015.

In addition, the ASPR estimates that 90% to 95% of generic sterile injectable drugs for critical acute care in the U.S. rely on materials and drug substances from China and India. Although the FDA created an Essential Medicines list in response to a 2020 White House directive, almost 50% of the antimicrobial agents listed have no domestic API manufacturing.

The report also indicates that under current law, manufacturers are not required to report an increased demand or export restrictions for essential medications or products used for life-support to the FDA. And this critical information could help the FDA alleviate shortages.

Furthermore, the federal government and the pharmaceutical industry lack the ability to visualize the pharmaceutical supply chain and have insufficient methods of mapping potential shortages.

Finally, the report highlights that while the FDA can recall food products, biological products like vaccines, medical devices, and controlled substances, it lacks the authority to require manufacturer recalls for most drug products. Instead, the agency can only recommend that a company recalls their drug product — which is often unsuccessful.

In his remarks at a hearing on the report’s findings, Senator Peters says, "taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security risks.”

In addition to outlining the current drug shortage challenges, the report offers some solutions. These include:

• The U.S. should invest in manufacturing critical generic drug products that regularly experience shortages.
• Congress should require other government organizations to jointly conduct regular medical supply chain risk assessments — including cybersecurity threats.
• The federal government and industry partners should continually update the Essential Medicines list and use it to guide manufacturing of critical drug products in the U.S.
• The government should require manufacturers of life-supporting drug products to report any increased demand and export restrictions to the FDA.
• The FDA should ensure its supply chain data is accessible by other agencies to monitor supply chain vulnerabilities and help predict shortages.
• The FDA should also have the authority to issue mandatory recalls on drug products that pose a danger to health.

The report concludes, "until the federal government and industry strengthen efforts to jointly assess and address their underlying causes, drug shortages will remain a consistent health and national security risk."