About this episode
Send a textEpisode DescriptionIn this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public trust. From the loss of Chevron deference to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States.Episode SummaryWhat does it really take to run the FDA, and how political should the agency be? Former FDA Commissioner Robert Califf reflects on his path to the role, the skills a commissioner actually needs, and why FDA must act as an impartial referee rather than a political actor. The conversation explores guidance versus regulation, the loss of Chevron deference, industry expertise, the revolving door debate, and how social determinants of health shape outcomes far more than medicine alone. A candid, opinionated look at regulation from someone who has seen every side of it.Key Topics DiscussedHow Dr. Califf became FDA Commissioner twiceWhy FDA should act as a referee, not a combatantGuidance documents and how they really functionPolitics, policy, and product level decision makingPreparing for the loss of Chevron deferenceWealth inequality as the biggest health problem in the U.S.Social determinants of health and FDA’s roleGeneric drugs, tobacco, and public health impactDigital health hype versus real-world impactThe FDA–industry revolving door debateWhy This Episode MattersAs courts, politicians, and industry challenge agency authority, understanding how FDA decision making actually works matters more than ever. This episode explains what regulation can and cannot do, where political pressure becomes dangerous, and why ignoring inequality undermines health outcomes no matter how advanced the science becomes.GuestRobert Califf Former Commissioner, U.S. Food and Drug Administration Instructor in Medicine, Duke UniversityDr. Califf has served twice as FDA Commissioner and brings decades of experience across clinical medicine, academia, industry, and government.HostDarshan Kulkarni Founder, The Kulkarni Law Firm Host, DarshanTalksCall to ActionSubscribe for more conversations on FDA regulation, enforcement, policy, and healthcare compliance. Questions or ideas for future episodes? Call, click, or email.Support the showwww.kulkarnilawfirm.com
