Rising drug shortages pose national security threat, Senate panel says

A new Senate report found that drug shortages in the U.S. are increasing in frequency and duration, due to over-reliance on foreign countries like China and India, which is posing national security concerns.

The report from the Democrat-led Senate Committee on Homeland Security and Governmental Affairs provided a damning indictment of the U.S. government’s ability to predict drug shortages and address them effectively. It also laid out troubling statistics on the rate of drug shortages.

The report said drug shortages increased by almost 30 percent between 2021 and 2022, with a five-year high of over 295 active drug shortages in place at the end of last year. The report also said the average drug shortage lasts about a year and a half, and that more than 15 “critical” drugs have been in shortage for more than a decade. 

“Shortages continue to have devastating consequences for patients and health care providers, including medication errors and treatment delays, and in some cases, have led to doctors having to ration lifesaving treatments,” the report said.

The report comes ahead of a committee hearing on the subject on Wednesday. 

It also cited an over-reliance on foreign countries for active pharmaceutical ingredients (API), criticizing “geographically concentrated” sources of key drug materials. That, paired with what the report said was “limited” domestic manufacturing capabilities, creates national security issues.

Between 2010 and 2015, the number of Chinese-based API manufacturers that are registered with the Food and Drug Administration more than doubled from 188 to 445. The report also noted that a majority of API facilities approved by the federal government were based in India as of 2021.

It called for the U.S. to invest in domestic manufacturing of critical generic drugs that are frequently in shortage, encouraging the federal government to partner with private companies to bolster production capabilities.

“These partnerships should encourage the use of advanced manufacturing technologies for critical drugs prone to shortages and bolster ongoing collaboration between academia and industry to further build opportunities for workforce training programs that bridge the gap from research and development to commercialization,” the report said.

The report also said the federal government should streamline its data collection and communication on possible supply chain shortages, and require companies to report demand and external restriction data to the government.