Abstract

Dr. Robert Califf recently ended his second tenure as the Commissioner of the Food and Drug Administration (FDA). Our conversation occurred on his one-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 Food and Drug Administration Commissioner. Dr. Califf discusses the balancing act between accelerated drug approvals and evidence generation, emphasizing the need for robust post-market 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 U.S. 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.

Information Accepted manuscripts
Accepted manuscripts are PDF versions of the author’s final manuscript, as accepted for publication by the journal but prior to copyediting or typesetting. They can be cited using the author(s), article title, journal title, year of online publication, and DOI. They will be replaced by the final typeset articles, which may therefore contain changes. The DOI will remain the same throughout.
This content is only available as a PDF.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact [email protected].