Beyond regulation: a conversation with Dr. Robert Califf on the challenges facing healthcare and innovating community-based solutions

Dr. Robert M. Califf recently ended his second tenure as the Commissioner of the Food and Drug Administration (FDA). Our conversation occurred on his 1-month anniversary of becoming a private citizen again. In our conversation, Dr. Califf shares his perspective on pressing healthcare challenges following his second tenure as FDA Commissioner. Dr. Califf discusses the balancing act between accelerated drug approvals and evidence generation, emphasizing the need for robust postmarket studies and the health system's role in evidence generation. He also advocates for a fundamental shift toward prevention-focused, community-based healthcare supported by technology to address the paradox of spending and health outcomes in the United States. As healthcare leadership in the new administration shifts health priorities, Dr. Califf highlights critical vulnerabilities in pharmaceutical supply chains and the urgent need to combat health misinformation in the digital age.