Woodcock: COVID Is Not The Time For Structural Changes At US FDA
Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.
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Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.
A central biostatistics team would embrace an academic focus that could elevate the specialty within FDA. It’s a question, Pazdur says, for the next commissioner.
Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.