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Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan

 
• By Sarah Karlin-Smith

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.

empty wallet
Congress may require FDA establish new Centers of Excellence without any corresponding new funding. • Source: Alamy

The US Food and Drug Administration would need to establish two new intercenter institutes or “Centers of Excellence” if Congress clears the new Cures 2.0 legislation. But without any new funding to do it, the plan could frustrate the agency, which has run into budgetary challenges with its first such intercenter institute the Oncology Center of Excellence.

The draft Cures 2.0 legislation requires the two centers to be established within a year of the bill’s enactment or the end of the coronavirus disease pandemic public health emergency, whichever is later

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