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2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization

 
• By Sue Sutter

Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.  

Silos. Warehouse storage of the harvest. Field with sunflowers.
The Office of New Drugs' massive restructurting eliminated some organizational silos, which made it easier for staff to work together on responding to the pandemic. • Source: Shutterstock

Strategic priorities and challenges in the coming year for the US Food and Drug Administration’s Office of New Drugs will be much the same as they were in 2020 – enabling efficient development and review of potential COVID-19 therapeutics while also striving to ensure that all the “routine” regulatory work on drugs and biologics unrelated to the pandemic gets done in a timely fashion.

However, one major challenge that OND put behind it in 2020 was a massive reorganization, which led to a flattening of the agency’s new drug review operations

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