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# FDA Sees Need to Better Address Drug Shortages
- URL: https://www.fdaweb.com/fda-sees-need-to-better-address-drug-shortages/
- Published: 2023-06-08T12:00:00.000Z
- Updated: 2026-09-14T18:37:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154641

In its 2022 report to Congress on drug shortages, FDA says its response to the Covid-19 pandemic highlighted two needs that require ongoing work to be fully addressed:

- gaining better insight into the supply chain since manufacturers are not required to notify FDA of increases in demand that they are unlikely to be able to meet without meaningful shortfall or delay; and
- increasing the resilience of the supply chain to provide redundancy to reduce the reliance on a single facility or geographic region.

“FDA is working with manufacturers and other partners to help prevent shortages from occurring and to mitigate the impact of shortages that cannot be prevented,” the [report](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvbWVkaWEvMTY5MzAyL2Rvd25sb2FkP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyMzA2MDguNzc5MjQ3NjEifQ.f1Z5LJz7VmXNnidxqcZFjGgpa7sfpPc-MSvV8XXIK-U/s/2992177567/br/204472761629-l?ref=fdaweb.com) says. “Early and open dialog between FDA and manufacturers is critical to the success of this work.”

The report indicates that in 2022 there were 49 new drug shortages, compared to a peak of 251 new shortages in 2011, and the agency successfully worked with manufacturers to prevent 222 shortages through the use of a range of available tools.

“Although the number of new drug shortages has declined since 2011 as a result of work by many groups, including FDA, shortages continue to pose a real challenge to public health,” the report says, “particularly when the shortage has involved a critical drug to treat cancer, to provide parenteral nutrition, or to address other serious medical conditions, such as a shortage of antibiotics. In the past year, FDA has seen manufacturers in the United States and abroad continue to experience quality issues as well as struggle with capacity constraints. 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.”