(WASHINGTON) — Patients and medical providers who rely on pharmaceutical medications to treat everything from asthma to ADHD to cancer may have had a harder time finding those medications last year than in years past, a new Senate report released Wednesday finds.
The report, issued by Senate Homeland Security and Governmental Affairs Committee Chairman Gary Peters, finds many drug shortages were exacerbated by the COVID-19 pandemic. Between 2021 and 2022, the report says, drug shortages increased by nearly 30%, creating challenges for health care providers and ailing patients, and, Peters says, possibly exposing the country to national security threats.
At the end of 2022, a five-year record was set with 295 active drug shortages. But while the COVID-19 pandemic may have heightened drug-access challenges, the report says the problem is not new: 15 essential drugs have been in short supply for over a decade.
One expert testifying to lawmakers Wednesday, Erin Fox, a pharmacist and professor at the University of Utah College of Pharmacy, has been tracking drug shortages since 2001.
Her team has found an abundance of drugs in short supply, most notably generic injectable drugs used at hospitals, such as anesthetics, some steroids and older chemotherapy agents. While the Senate report highlights a variety of shortages, it points specifically to shortages of Vincristine, a critical adult and pediatric chemotherapy drug used to treat various types of cancer with no alternative treatment, and Bacillus Calmette-Guerin (BCG), an immunotherapy biologic drug used to treat bladder cancer.
“Because of shortages, patients and hospitals routinely cannot access the most basic and essential prescription medications,” Fox plans to tell the Senate Homeland Committee.
She told ABC News she plans to describe the challenges of providing medical care in an environment where shortages are commonplace, citing studies that show adverse patient outcomes when providers are faced with shortages.
“Shortages adversely impact patients, health care professionals, and health systems. An entire generation of clinicians has never practiced during a time without shortages,” Fox will tell the committee.
Peters, the committee chairman, began examining drug shortages in 2019, before COVID-19 increased scrutiny of the problem. Since his 2019 report, shortages have increased, in part due to U.S. reliance on foreign providers for some active pharmaceutical ingredients necessary to give medications their desired effect. That reliance became a critical weakness for the United States during the pandemic when some foreign countries placed limits on exports of pharmaceuticals.
“Our continued over-reliance on foreign suppliers for the key materials needed to make critical drugs, primarily those in China, remains an unacceptable national security risk,” the Illinois Democrat will argue.
The new report finds that nearly 80% of manufacturing facilities that produce active pharmaceutical ingredients — the key ingredients that give a drug its intended effect — are located outside of the U.S., with the number of China-based manufacturers registered with the Food and Drug Administration more than doubling from 2010 to 2015.
Outsourcing production to India and China means the U.S. is vulnerable to global catastrophes and at the whim of market forces. If the U.S. faces another pandemic or global crisis, it could experience even more serious supply chain issues with key pharmaceuticals.
The report also identifies what it says are blind spots in the ability of the FDA and other U.S. regulators to monitor or address shortages.
Under current law, manufacturers aren’t required to report increased demand or export restrictions for drug products to the FDA, making it challenging for the regulating agency to anticipate shortages coming down the pike. In the report, the Senate Homeland Committee recommends Congress implement changes to these rules.
The FDA also doesn’t have a list of life-supporting and life-sustaining drugs, leaving it unable to assess the number of drugs that have a limited number of manufacturers or that rely on only one supplier for production.
“The federal government’s inability to comprehensively assess U.S. pharmaceutical supply chain vulnerabilities and address known causes of shortages for critical drugs continues to frustrate efforts to predict drug shortages and effectively mitigate their impact on patient care,” the report finds.
It’s not yet clear what, if any, action Congress can take to try to shore up supply chains for key pharmaceuticals.
The committee report recommends new federal investment in domestic manufacturing of key drug products that are regularly in short supply. Congress took similar action in a separate sphere last year after determining that reliance on foreign-produced microchips used to power cars, computers and other technology posed a national security risk, by passing the CHIPs and Science Act which provided billions to incentivize onshore production of computer chips.
It’s not clear if a similar effort geared toward pharmaceuticals could gain traction in Congress.
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