Scott Gottlieb
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- Milken Institute34 min
A Conversation with Scott Gottlieb, Commissioner, U.S. Food and Drug Administration
Scott Gottlieb, Tanisha Carino, Michael Milken
The FDA is implementing a comprehensive strategic shift to accelerate drug approvals through digital health integration, organizational restructuring within the Office of New Drugs, and a transition to risk-based, post-market regulation for digital tools and manufacturing. This initiative aims to increase review productivity by 20%, publish hundreds of new guidances, and release detailed approval memos within 48 hours to enhance transparency while addressing pipeline disparities in rare versus common diseases. Concurrently, the agency prioritizes tobacco control through modified risk products and fosters market competition to lower drug costs, with Commissioner Gottlieb warning that ossified reimbursement models for novel therapies threaten future innovation if not adapted.
- Milken Institute35 min
A Conversation with FDA Commissioner Scott Gottlieb
Former FDA Commissioner Scott Gottlieb outlines a multifaceted regulatory strategy addressing the opioid epidemic, tobacco addiction, and the aftermath of Hurricane María on Puerto Rico's critical medical manufacturing sector. He emphasizes adapting regulatory frameworks for emerging technologies like artificial intelligence and digital health tools while prioritizing the prevention of medical misinformation and product shortages. The discussion highlights a shift toward reducing review cycles, de-risking early-stage development, and utilizing post-market surveillance to balance safety with innovation.