Can We Trust the FDA? Marty Makary on Science, Power & Patients

Overview

This episode features FDA Commissioner Marty Makary discussing transformative reforms at the FDA, the race against China in biotech, reshaping outdated health policies, and leveraging innovation to improve public health. Key topics include accelerating drug approvals, addressing the obesity epidemic, rethinking vaccine schedules, and tackling systemic issues in healthcare pricing and nutrition.

Notable Quotes

- Why does it take 10 to 12 years for a new drug to come to market? We've become so lukewarm and passive, accepting that horrible timeline. – Marty Makary, on the urgency of FDA reforms.

- 38% of kids have pre-diabetes or diabetes. Is that a surprise? We've pumped refined carbohydrates and sugar into their diets for decades. – Marty Makary, on the failures of the U.S. food system.

- We are streamlining and modernizing the FDA, and we are not wasting time. We're getting stuff done. – Marty Makary, on his mission to accelerate healthcare innovation.

🚀 FDA Reforms and Accelerating Drug Approvals

- Makary has implemented 42 major reforms in 10 months, including reducing drug approval timelines and increasing transparency by making FDA rejection letters public.

- The FDA is piloting programs to cut drug approval times from years to weeks, leveraging AI and Bayesian statistics for real-time data analysis.

- A shift from requiring two pivotal trials to one for drug approval could save companies $100-$300 million and expedite life-saving treatments.

- The FDA is eliminating outdated animal testing requirements, replacing them with modern techniques like organ-on-a-chip technology.

🌍 Competing with China in Biotech

- The U.S. is losing ground to China in biotech innovation due to inefficiencies and red tape. China completes phase one trials in 4 weeks compared to the U.S.'s lengthy timelines.

- Makary advocates for centralized IRBs and streamlined hospital contracting to reduce delays.

- Proposed policies include higher user fees for overseas trials to incentivize domestic research and development.

🍎 Reshaping Nutrition and the Food Pyramid

- The FDA has flipped the outdated food pyramid, emphasizing protein and reducing the focus on refined carbohydrates.

- Makary highlights the role of ultra-processed foods and refined carbs in driving the obesity and diabetes epidemics among children.

- The FDA has banned nine artificial petroleum-based dyes and is closing loopholes in the GRAS (Generally Recognized as Safe) system to ensure food safety.

💉 Rethinking Vaccines and Public Trust

- The U.S. vaccine schedule, with 72 doses by age 18, is an international outlier. Makary introduced a core essential vaccines list to rebuild public trust and increase vaccination rates.

- He criticized the absolutism around vaccines, advocating for a more nuanced, science-based approach to recommendations.

- Makary emphasized the need to meet people where they are, citing declining childhood vaccination rates due to public mistrust.

💊 Lowering Drug Prices and Expanding Access

- The FDA is pushing for most favored nation pricing, ensuring Americans pay the lowest prices for drugs globally.

- Reforms to biosimilar approval processes aim to reduce costs and increase competition in the biologics market.

- Makary is advocating for more over-the-counter drugs to bypass the opaque pricing schemes of Pharmacy Benefit Managers (PBMs) and increase price transparency.

- AI and wearables are being deregulated to improve accessibility, with clear guidelines for medical-grade claims.