Washington — The United States is overly reliant on China, India and other countries for crucial pharmaceutical drugs, which has contributed to shortages over the last two years, a new Senate report led by Michigan Sen. Gary Peters found.
The Democrat from Bloomfield Township chairs the Senate Committee on Homeland Security and Governmental Affairs, which issued a report Wednesday showing shortages of necessary pharmaceutical drugs rose 30% between 2021 and 2022.
The increase in shortages builds on systemic issues that drive down supply, including market conditions that drive away manufacturers, opaque supply chains, and over-reliance on foreign sources of drug components, the report says.
"Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security risks," Peters said in prepared opening remarks for a Homeland Security committee hearing on the findings that will be held Wednesday morning.
Most drug shortages last for around a year and a half, according to the American Society of Health-System Pharmacists. But hormonal drugs that slow the onset of cancer and other conditions have average shortages of more than three years; local anesthetics face shortages of more than two years; and chemotherapy drug components and cardiology agents have shortages of more than a year and a half.
Up to 95% of generic sterile injectable drugs used for critical acute care in the United States relies on materials that come from China and India, the report says. The number of China-based drug ingredient companies that registered with the Food and Drug Administration between 2010 and 2015 more than doubled from 188 to 445, and most drug ingredient manufacturers approved by the FDA are in India.
The government and the industry itself does not know the details of the end-to-end supply chain for needed drugs, which makes it difficult to identify chokepoints that could impact supply. And the FDA does not have the authority to force a company to recall all drugs as it does with food, vaccines and medical devices, according to the report.
Peters recommends that the government "invest in advanced manufacturing capabilities to produce critical drugs here in the U.S., and require that the FDA and its interagency partners can get the information needed to better monitor supply chain vulnerabilities and anticipate possible shortages."
Investments should be targeted at critical drugs that are prone to shortages, Peters wrote in the report, and Congress should require key federal agencies to conduct regular risk assessments to understand shortages and cybersecurity threats.
The report also recommends Congress require drug manufacturers to report to the FDA when they experience an increase in demand for "life-supporting and life-sustaining" drug products, and give FDA the ability to recall drug products that threaten people's health.
Peters' findings come amid media reports of shortages in cancer treatment drugs and other pharmaceuticals, and on the tail of the coronavirus pandemic which exposed other shortages in the medical supply chain as the nation's hospitals scrambled to find ventilators, masks, gloves and other equipment needed to treat Covid-19 patients.
Peters, then ranking member on the committee, issued a similar report in 2019 showing vulnerabilities that contribute to drug shortages.