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# Supply Chain Changes Needed to Ease Drug Shortages: FDA
- URL: https://www.fdaweb.com/supply-chain-changes-needed-to-ease-drug-shortages-fda/
- Published: 2022-06-21T12:00:00.000Z
- Updated: 2026-09-14T17:49:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152113

The FDA report to Congress on Drug Shortages for CY 2021 identifies two supply chain changes that require ongoing work to help ease drug shortages. The [report](https://www.fda.gov/media/159302/download?ref=fdaweb.com) identifies them as: 

- need to gain better insight into the supply chain; and
- need to increase the resilience of the supply chain.

“To address shortages, including those related to the Covid-19 pandemic, 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 says. “Early and open dialog between FDA and manufacturers is critical to the success of this work.”

The report says that during 2021, CBER and CDER worked with manufacturers to successfully prevent 317 drug shortages through the use of a range of tools, including regulatory flexibility and discretion when appropriate. In the same period, it says, the number of new shortages tracked by CBER and CDER was 41, compared to a peak of 251 new shortages during CY 2011.

“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. “This is especially the case when the shortage involves a critical drug to treat cancer, to provide parenteral nutrition, or to address other serious medical conditions, such as a shortage of blood pressure medications. In the past year, FDA has seen manufacturers in the U.S. and abroad continue to experience quality issues as well as struggle with capacity constraints. Additionally, as demand increased for numerous drugs over the last year as a result of the Covid-19 pandemic, FDA has seen additional strain on the pharmaceutical supply chain.”

FDA says that based on the agency’s experience and the data on drug shortages included in the report, it believes that requirements related to early notification of interruptions and discontinuances in manufacturing and FDA’s actions are helping to reduce the threat and impact of drug shortages.