Supercharging a New FDA: Marty Makary on Science, Power & Patients
All-In with Chamath, Jason, Sacks & Friedberg Podcast Recap
Published:
Guests: Marty Makary, Dr. Vinay Prasad
What Happened
Marty Makary, the Commissioner of the FDA, is leading an ambitious reform agenda with 42 major changes in his first ten months. Among these, he has made rejection letters public and banned nine petroleum-based dyes, aiming to enhance transparency and safety.
The FDA is undergoing significant structural changes, notably cutting non-essential staff while maintaining scientific reviewers. With a 5-7% turnover rate consistent over the past decade, the agency is also onboarding 1,000 new scientists to rejuvenate its workforce.
Makary is tackling the lengthy drug approval process, traditionally taking 10-12 years, by piloting programs that expedite decisions to a matter of weeks. This includes reducing animal testing requirements and exploring alternatives like computational modeling and organ-on-a-chip technology.
A major shift is in drug approval criteria, moving from two pivotal trials to one, potentially saving companies $100-300 million. The FDA is also considering continuous trials and Bayesian statistical evaluations to further streamline approvals.
Post-market surveillance is a priority for the FDA, using big data to identify safety signals earlier. The FDA's modernization efforts also include digitizing millions of files and employing AI to improve efficiency.
Makary supports the 'right to try' law, allowing patients access to drugs before full approval, with 100% of requests backed. The FDA is also reducing regulatory burdens for cell and gene therapy manufacturing to speed up access.
The U.S. faces a three-year window to compete with China's growing influence in biotech. China is increasing its share in licensing deals and scientific publications, posing a significant challenge to U.S. dominance.
Makary is addressing public health issues, including the flawed food pyramid influenced by the food industry, and the U.S. vaccine schedule, which is an international outlier. Proposals include a new core essential vaccine list and a revised pyramid emphasizing protein over refined carbs.
Key Insights
- Marty Makary has implemented 42 major reforms at the FDA in just ten months, focusing on transparency and modernization. Key changes include making rejection letters public and banning certain petroleum-based dyes.
- The FDA is reducing the drug approval timeline by piloting expedited programs that cut decision times from years to weeks. This involves embracing new technologies like organ-on-a-chip and computational modeling.
- China poses a challenge to U.S. biotech dominance, with a three-year window to keep up with Chinese innovation. China's share in licensing deals and scientific publications is rapidly increasing.
- The FDA is addressing public health flaws, such as the outdated food pyramid and controversial vaccine schedules. Proposals include a revised pyramid emphasizing protein and a new list of core essential vaccines.
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