FDA Commissioner Dr. Marty Makary Lays Out Plan for Modernizing the Agency
What this video covers
FDA Commissioner Marty Makary is interviewed on the New York Stock Exchange trading floor during a New York Bio event; in the conversation he notes they are sitting down in December 2025, a little under a year into his tenure. In under ten minutes he lays out his modernization agenda — faster approvals, radical transparency, food policy — and his plan to restore public trust in the agency.
Key points
- On streamlining, Makary says the FDA has reduced animal-testing requirements, opened applications to real-world data, and cut the requirement from two pivotal trials to one well-designed trial, which he says can achieve the same statistical power and lets companies run twice as many drugs through development.
- He describes a pilot program to get FDA decisions out “in a matter of weeks” for game-changing therapies, and says he wants to see a cure or meaningful treatment for type 1 diabetes, certain neurodegenerative diseases and some cancers during his tenure, citing recent multiple myeloma results.
- On transparency, Makary says the FDA has made its rejection letters public for the first time in its history so developers and investors can see reviewers’ reasoning; he cites an analysis finding that 80% of FDA decisions unfavorable to companies were not truthfully represented to the public.
- On trust, Makary cites public trust in doctors and hospitals falling from 71% in 2019 to 40%, calls that “an American tragedy,” and says the agency must show humility — during COVID, he says, the right answer was sometimes “we don’t know.” He promises daily transparency on adverse events and points to the revised hormone therapy black-box warnings and an OxyContin label update as honesty-driven corrections.
- On food, Makary says rewritten nutrition guidance would be out “in a matter of weeks,” that all nine petroleum-based food dyes are being removed with natural replacements approved at record speed, and that the FDA is evaluating chemicals banned in Europe and closing the GRAS loophole.
- On manufacturing, Makary backs an “America First” agenda: the FDA now offers to inspect facilities while they are being built rather than after a one-to-two-year lag, and he cites Novartis’s goal of making all medications for American patients in the United States.