The United States Pharmacopeia, an independent, science-based nonprofit, released its first annual Drug Shortage Report (USP) showing that drug shortages are currently at the highest level in a decade with 2023 marking the worst year yet.
Over the past 10 years, the number of drug shortages has increased dramatically, the report explains, with 125 active drug shortages monitored by the U.S. Food and Drug Administration (FDA) at the end of 2023.
“This high number of shortages is a direct result of persistent market vulnerabilities,” the report states. “According to our analysis, over a quarter of drugs in shortage were new drug shortages (34 products) in 2023.”
Published in early June, the report explains that the average drug shortage lasts more than three years and impacts multiple types of drugs. One in four drug shortages lasted more than five years while six drugs, including epinephrine injections for serious allergic reactions, have been in low supply for a decade. More than half of all new drug shortages involve injectable generic medications.
“Unexpected shocks can break the system and disrupt the supply of quality medicines,” said Anthony Lakavage, senior vice president for Global External Affairs at USP, a nonprofit organization that sets global quality standards for medications, dietary supplements, and food ingredients.
“This worrisome trajectory leads to more frequent drug shortages, prolonged scarcity, and more people at risk of not getting the medicines they need when they need them.”
(Related: Pharmaceutical drug manufacturing has degraded so badly with so many contamination problems that the Department of Defense [DoD] has intervened to call for outside testing.)
U.S. manufacturing falling apart
A big part of the problem is the manufacturing complexity involved with many drugs such as sterile injectables and antibiotics. These drug classes require dedicated facilities capable of complicated chemical synthesis – facilities that are increasingly in short supply in
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