Califf at Milken Institute, November 13, 2024

Event 

https://milkeninstitute.org/content-hub/event-panels/part-1-conversation-fda-commissioner-robert-califf-1

Transcript

https://otter.ai/u/eg-ltfZpXu6OHBphoCJ16fHKIEQ?utm_source=copy_url

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Chat GPT4

Subject: Detailed Summary of Conversation between Dr. Robert Califf, Outgoing FDA Commissioner, and Esther Krofah, Milken Institute Health Summit – November 13, 2024

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Overview

The November 13, 2024, Milken Health Summit hosted a conversation between Dr. Robert Califf, outgoing FDA Commissioner, and Esther Krofah, Executive Vice President of Health at the Milken Institute. This discussion provided insights into Dr. Califf’s reflections on his tenure, challenges he faced, and his perspectives on FDA's future regulatory responsibilities, including areas such as food safety, medical product innovation, AI in healthcare, and diversity in clinical trials.

Key Discussion Points

1. Opening Remarks and Background of Califf’s Tenure

• Krofah opened by acknowledging Dr. Califf's “two tours of duty” as FDA Commissioner, specifically highlighting his leadership during crises, such as the Abbott infant formula recall.
• Califf shared that this crisis occurred on his first day back, emphasizing the immediate need for response and crisis management. His leadership has been marked by rapid adjustments to unexpected challenges.

2. Califf’s Reflections on Legacy and Accomplishments

• FDA's Role in Food Safety: Califf discussed the major reorganization of FDA’s food division, a response to the growing complexity of food safety regulation. This reorganization involved approximately 8,000 staff, predominantly focused on inspections rather than nutrition—a limitation influenced by congressional budget allocations.
• Medical Product Innovation: On the medical product side, Califf highlighted FDA’s expanded focus on cross-department collaboration, especially in rare diseases. He noted the FDA’s essential role in balancing product innovation with safety, maintaining its global reputation as the “gold standard” for regulatory bodies.

3. Challenges in U.S. Healthcare Delivery and Innovation

• Califf expressed concern about the U.S.’s healthcare system, pointing out that the country’s innovative capacity does not translate effectively into accessible healthcare for all. The U.S. ranks last among high-income nations in healthcare access and outcomes, a concern he believes extends beyond FDA’s scope but requires multi-stakeholder action.

4. FDA’s Role in Artificial Intelligence (AI) Integration in Healthcare

• Califf articulated that FDA is prepared to oversee certain aspects of AI-driven medical advancements, particularly those related to molecular discovery and clinical trial design. He highlighted FDA’s expertise in assessing safety and efficacy in clinical settings.
• However, Califf identified AI decision support in healthcare delivery as an area that lacks robust monitoring. He advocated for an “ecosystem” approach where FDA guidelines support self-regulation, similar to how farms adhere to food safety standards between inspections. This ecosystem approach is essential for safely integrating generative AI into clinical environments, recognizing AI’s potential to dynamically improve patient care.

5. Evidence Generation and Post-Market Trials

• Califf discussed the need for evidence generation throughout a medical product's life cycle, emphasizing the importance of post-market data for real-world efficacy and safety evaluations. He referenced pragmatic trials, which involve broader patient demographics and lower costs, as an optimal way to address questions not fully explored in pre-market trials.
• FDA’s partnership with CMS (Centers for Medicare & Medicaid Services) was highlighted as a positive example of collaboration to set post-market evidence standards. This partnership is essential for evaluating long-term product effectiveness and could drive future regulatory processes that combine pre- and post-market insights.

6. Challenges in Diversity and Accessibility in Clinical Trials

• Diversity Action Plans: Califf emphasized the need for comprehensive diversity action plans across all stages of drug development, not limited to phase III trials. He explained that these plans should ensure the representation of the populations that will eventually use the treatments.
• Structural Bias in Healthcare: Califf recognized that clinical trials alone cannot correct structural healthcare disparities, especially along socioeconomic and rural-urban divides. He noted that, with clinical trials becoming smaller, capturing a representative sample of global populations remains an immense challenge. This issue requires innovative solutions and expanded use of digital interfaces to reach underrepresented populations, especially in rural areas with limited access to specialized care.

7. Public Health, FDA’s Role, and Societal Perceptions

• Califf addressed the heightened scrutiny public health agencies face, particularly during crises like the COVID-19 pandemic. He argued that successful public health often goes unnoticed because crises are averted. Nonetheless, he underscored that the U.S. healthcare system has notable deficiencies, such as poor diet and declining life expectancy, that require urgent public health reform beyond FDA’s regulatory duties.
• Dietary health was cited as a particularly concerning area, with Califf stressing that quick fixes like dietary supplements are not substitutes for healthier eating habits. He advocated for public health measures that promote sustainable, systemic changes to Americans' dietary behaviors.

8. Advice for Future FDA Leadership

• Executive Skillset: Califf advised future commissioners to emphasize executive capabilities, including active listening, collaboration, and crisis management. He cautioned against a purely prescriptive approach, urging future leaders to remain adaptable to diverse challenges.
• Commitment to Evidence-Based Decisions: Califf recommended a strong commitment to evidence generation and analysis as central to sound FDA decision-making.
• Distinguishing Science from Politics: While recognizing the influence of political factors on FDA policy, Califf suggested that individual product decisions should remain grounded in scientific evidence. He explained that while policy affecting broad categories of products may involve political considerations, decisions on specific products should be evidence-based to maintain FDA’s integrity.

Conclusion

This dialogue showcased Dr. Califf’s reflections on FDA’s progress and areas needing continued focus, particularly as they relate to public health, regulatory science, AI integration, and clinical trial diversity. His insights highlight FDA’s pivotal role in supporting innovation while safeguarding public health, as well as the necessity of an ecosystem-based approach in the evolving regulatory landscape. The conversation ended with gratitude for Califf’s service and contributions, underscoring the complex, multi-faceted role FDA plays in modern healthcare.