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Sen. Wyden Using Califf Nomination To Extract Accelerated Approval Reforms

 
• By Sarah Karlin-Smith

The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.

boot on thin breaking ice
Califf’s nomination to lead FDA is on thin ice. • Source: Alamy

US Food and Drug Administration Commissioner nominee Robert Califf agreed to take fast and “strong action” to hold pharmaceutical companies accountable for producing the scientific evidence required of accelerated approval drugs if confirmed for a second chance at leading the agency, a 4 February letter from Senate Finance Committee Chair Ron Wyden says. 

Califf made the pledge to take action within 30 days of assuming office during a recent meeting with the Democratic...

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