659. Can Marty Makary Fix the F.D.A.? - Freakonomics Radio Recap

Podcast: Freakonomics Radio

Published: 2026-01-16

Duration: 55 minutes

Guests: Marty Makary

Summary

Marty Makary, the FDA's commissioner, has ambitious plans to modernize the agency by incorporating AI and reducing red tape, aiming for faster drug approvals and healthier food standards. The episode examines his strategies and the challenges involved in reforming such a significant regulatory body.

What Happened

Marty Makary, the current FDA commissioner, is spearheading a wave of reforms aimed at modernizing the agency's practices. One of his primary goals is to expedite the drug approval process by utilizing AI tools like ELSA, which can streamline application reviews. This is part of a broader effort to cut through regulatory red tape and encourage innovation in drug development.

Makary is also focused on addressing the imbalance in consumer health information, particularly concerning direct-to-consumer pharmaceutical advertising. With the U.S. being one of the only two countries allowing such ads at their current magnitude, Makary argues for stricter scrutiny to ensure that pharmaceutical claims are accurate and balanced with potential side effects.

A significant aspect of Makary's agenda involves redefining dietary guidelines and removing harmful substances from food products. This includes efforts to end the longstanding demonization of natural saturated fats, which were unfairly labeled as unhealthy by the sugar industry. The FDA is now working to eliminate petroleum-based food dyes and revise the food pyramid for better nutritional guidance.

Makary's tenure is also marked by a push for price transparency and affordability in the pharmaceutical industry. The FDA is using market incentives to encourage companies to lower drug prices, while prioritizing applications that address unmet public health needs or offer significant cost reductions.

The episode also delves into the limitations of animal testing for drug efficacy, highlighting the potential of organs-on-a-chip technology as a more reliable alternative. This innovation could reduce the reliance on animal testing, which has shown to be ineffective with 90% of drugs failing to translate from animals to humans.

Additionally, Makary is advocating for the development of a universal flu shot and exploring promising treatments for conditions like PTSD and type 1 diabetes. He emphasizes the need to pursue bold and unprecedented initiatives to advance medical treatments significantly.

The episode concludes with a discussion on the fiscal policies affecting the FDA and NIH, including the controversial proposal to cut the NIH's 2026 budget by $18 billion. Despite this, the NIH's budget continues to grow, with funds being redirected towards impactful research projects instead of descriptive DEI studies.

Key Insights

• The FDA is utilizing AI tools like ELSA to expedite the drug approval process, aiming to streamline application reviews and reduce regulatory delays in drug development.
• The U.S. is one of only two countries that allow direct-to-consumer pharmaceutical advertising at its current scale, prompting calls for stricter scrutiny to ensure accurate and balanced pharmaceutical claims.
• Organs-on-a-chip technology is being explored as an alternative to animal testing, as 90% of drugs fail to translate from animal models to humans, highlighting the limitations of current testing methods.
• A proposal to cut the NIH's 2026 budget by $18 billion has been met with controversy, although the NIH's budget continues to grow with a focus on funding impactful research projects.