FDA Identifies Need for Better Addressing Drug Shortages

In its mandated report to Congress on drug shortages in the calendar year 2020, FDA identifies two needs that require ongoing work to improve its ability to manage and respond to shortages. The report identifies them as: 

•          need to gain better insight into the supply chain, and
•          need to increase the resilience of the supply chain.

The report says the agency believes the requirements relating 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. FDA will continue to prioritize 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.”

The agency identified 43 new shortages in 2020, it says, and helped prevent 199 potential shortages.