In its annual report to the U.S. Congress on drug shortages, the U.S. Food and Drug Administration (FDA) cited the COVID-19 pandemic, supply chain problems, and approval processes as reasons for the shortages during the 2022 calendar year.
“FDA has seen manufacturers in the United States and abroad continue to experience quality issues as well as struggle with capacity constraints,” the agency wrote in the report. “Additionally, as demand increased for numerous drugs over the last several years as a result of the COVID-19 pandemic, as well as an earlier than typical flu and respiratory virus season, FDA has seen additional strain on the pharmaceutical supply chain.”
To help curb shortages following presidential, congressional, FDA actions, manufacturers are notifying FDA earlier about certain manufacturing interruptions and discontinuances that can lead to shortages. FDA said that these early notifications give the agency additional time to work with manufacturers and other stakeholders to identify ways to maintain treatment options and prevent a shortage.
“Based on FDA’s experience to date and the data on drug shortages presented in this report, FDA believes that the requirements related to early notification of interruptions and discontinuances in manufacturing and FDA’s own actions are helping to reduce the threat and impact of drug shortages,” the agency also wrote in the report. “FDA will continue to prioritize its efforts on this important public health issue, working to ensure the availability of necessary drugs and biological products for the American public, including adequate supplies of drugs needed to treat patients with COVID-19 and other respiratory illnesses.”