In 2023, drug shortages in the US decreased from their peak between 2010 and 2012, which is good news. However, they were the highest since 2012, which is concerning.
This information is from an FDA Report to Congress, which highlighted a significant increase in shortages for biologic drugs (regulated by CBER) in 2023. The FDA attributes this rise to manufacturing and quality issues at one facility, along with global supply chain challenges.
CY 2023 has been a challenging year for shortages. For example, the notable increase in new shortages of CBER-regulated biological products was due to manufacturing problems and quality procedures at one manufacturer that experienced global supply chain issues related to the lack of some materials and components needed for the manufacturing process. FDA has seen manufacturers in the United States and abroad continue to experience quality issues and struggle with capacity constraints.
You can access the full report here.
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