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

Date: January 15, 2026
Guest: Dr. Marty Makary, Commissioner of the FDA
Host: David Friedberg

Overview

This episode features a candid and in-depth conversation with Dr. Marty Makary, Commissioner of the FDA, recorded during the JP Morgan Healthcare Conference in San Francisco. Friedberg explores Dr. Makary’s reforms at the FDA, the legacy of COVID-era medical dogma, U.S. competitiveness in biotech, regulatory modernization, food policy, vaccine schedules, and efforts to rebuild public trust in health institutions. The discussion is practical, sometimes provocative, and focused on rapid innovation and transparency in American healthcare.

Major Themes and Discussion Points

1. Marty Makary’s Path to the FDA & Philosophical Influences

(00:31–03:21)

• Makary’s academic work centered on transparency in healthcare costs and questioning legacy systems.

• Noted for outspoken COVID-era positions—questioning cloth mask mandates in toddlers, vaccine mandates for low-risk groups, and the neglect of natural immunity.

• Makary:

  “We still suffer from…suppressing ideas that are not the legacy ideas, the sort of sacrificing the basic principles of science to question everything, to have no sacred cows.” (01:25)

• His advocacy led to White House engagement and eventually to his appointment as Commissioner after Trump’s reelection.

2. FDA Institutional Reforms & Pushback

(03:21–07:50)

• Makary launched 42 major reforms in his first 10 months, aiming for internal transparency and faster drug approvals.
• Public release of FDA’s drug rejection letters to enhance accountability.
• Streamlined staffing, particularly in HR and IT, without cutting scientific reviewers; morale and teamwork have improved.
• Outlined a shift from previous commissioner’s “anti-misinformation” focus to making cures and safe foods available faster.
• Makary:

  “My number one priority is not to censor Americans. It's to deliver more cures and meaningful treatments faster…Every employee knows that mission.” (06:24)

3. U.S.-China Biotech Race & Structural Competitiveness

(07:50–11:30)

• China’s rapid rise in biotech publications, licensing, and deal-making has triggered U.S. concerns.
• U.S. regulatory delays (e.g., IRBs, hospital contracts, 60-day FDA review lags) contrast with China/Australia’s 4-6 week approval timelines.
• Makary calls for centralized IRBs, streamlined hospital contracts, and aggressive use of AI to accelerate U.S. clinical research.
• Makary:

  “We have got to have more centralized contracting and a centralized IRB in order to compete. Those are big priorities…We're going to use AI. We've got to modernize the agency.” (10:19)

4. Drug Approval Processes & Reducing Regulatory Burden

(13:14–18:19)

• Explains drug development: IND, Phase 1 (safety, healthy subjects), Phase 2 (limited efficacy), Phase 3 (large pivotal trial).
• FDA shifting from two pivotal trials to one, saving money and accelerating timelines.
• Cutting animal testing requirements; advancing computational models and “organ-on-a-chip” technology.
• New voucher-based fast track program for drugs that:
  • Meet unmet public health needs
  • Bring manufacturing back to the U.S.
  • Are priced affordably
• Early pilot: approval in 55 days for select drugs.
• Makary:

  “We are eliminating a lot of animal testing requirements ... 90% of drugs that pass animal studies do not pass safety and efficacy in humans. So what are we doing?” (15:17)

5. AI, Continuous Trials & Real-Time Drug Safety Surveillance

(19:19–23:19)

• Discusses integrating real-world data, AI, and Bayesian statistics to enable continuous, rolling trials and faster safety/efficacy signals.
• Argues for ongoing post-market analysis:

  “Why did we learn five years after Vioxx was approved that it may have killed 38,000 people?...In the modern world with big data, we can have eyes on a drug as it's being used in real time.” (21:20)

• Eliminating unnecessary lags, enabling faster drug withdrawals, and protecting sub-populations.

6. Rethinking FDA’s Balance of Safety and Speed

(23:19–25:23)

• Challenges absolutism in “zero risk.”
• Time delays in approvals have real, lethal consequences for patients.
• Makary:

  “Time delays that are unnecessary have risks. And I think that is something we don’t think about enough at the FDA.” (24:31)

7. Expanding the “Right to Try” & Flexible Regulation

(25:23–29:17)

• Makary supports “Right to Try;” has approved all qualifying requests.
• Points out abuse potential with false hope therapies.
• Announced regulatory simplification for cell/gene therapies (e.g., eliminating costly batch manufacturing standards for bespoke therapies).
• Developed “plausible mechanism pathway” for rare conditions lacking standard trials.

8. Lowering Drug Costs, Accelerating Biologics & Biosimilars

(59:14–66:41)

• U.S. drug prices are 2-3x higher than international rates.
• Trump admin pursuing “most favored nation” status, forcing drug companies to match the lowest price in developed countries.
• Major push on biosimilars (complex generic biologics): reducing R&D cost and timelines, creating real market competition.
• Makary:

  “We have changed the requirements...reducing the cost of R&D of biosimilars by $100 million plus.” (1:00:54)

• Plans to move more drugs to over-the-counter status, bypassing paternalistic prescription controls, increasing transparency and competition.

9. Revising the Food Pyramid & Root Causes of Chronic Disease

(33:12–41:02)

• Historic food pyramid was shaped by dogma and food industry influence, promoting refined carbs over proteins and healthy fats.
• Flipped the pyramid: prioritizing protein, warning about processed carbs, spotlighting groupthink mistakes (e.g., peanut avoidance, fat demonization).
• “Nutrition science may be one of the most corrupted fields in all of science.” (33:27)
• Links current policy to surging rates of prediabetes/diabetes in children, rising obesity, and chronic disease.

10. Vaccine Schedule Reforms & Restoring Trust

(49:54–58:29)

• U.S. vaccine schedule was longest worldwide (72 doses for ages 0–18); many are not internationally aligned.
• New FDA guidance identifies ~38 “core essential” vaccines, aiming to improve trust and compliance while allowing flexibility.
• Emphasizes humility and transparency about uncertainty in science, contrasting to COVID-era dogmatism.
• Addresses the need to meet people where they are, rather than doubling down on official orthodoxy.
• Calls out political polarization and states setting their own rules (e.g., California).
• Makary:

  “American medicine needs to show some humility...During COVID the right answer…was, we don’t know.” (58:09)

11. NIH Funding, Science Direction, and Research Priorities

(44:19–49:54)

• Rebuts claims of “anti-science” policy: argues no NIH or Medicaid cuts, points to reallocations (e.g., away from DEI and legacy genetic programs) toward root causes—nutrition, microbiome, school lunch, direct environmental triggers.
• Makary:

  “We want to see funding go to root causes of diseases...Not just is there a genetic cure for autism.” (46:29)

12. Technology, Digital Infrastructure & Organizational Overhaul

(31:13–33:12)

• Details outdated, dysfunctional bureaucracy (e.g., physically moving files, redundant agency silos, staff hired just for ink cartridges).
• Major digitization underway; onboarding 1,000+ new scientists.

13. AI & Direct-to-Consumer Diagnostics

(71:22–73:24)

• AI tools are promising; FDA focuses on transparent, predictable guidelines.
• Differentiates between consumer-grade and “medical-grade” AI, with the latter requiring robust validation and FDA approval.
• Wearables will be deregulated unless making specific medical claims.

14. Alternative Proteins, GRAS, and Food Innovation Policy

(73:49–78:39)

• Revising the GRAS (Generally Recognized As Safe) self-certification process; closing loopholes abused by highly processed foods.
• Advocates common sense in protein policy, support for alternative/cellular proteins, while recognizing state-level regulatory skirmishes.

15. Autism, Microbiome, and Environmental Hypotheses

(78:56–83:49)

• Increase in autism diagnoses sparks debate; possible autoimmune triggers, folate pathway, and profound microbiome effects are considered.
• Antibiotics, processed foods, and environmental exposures may contribute.
• Calls for deeper research on environmental and microbial factors, not just genetic approaches.

16. What’s Next: Most Exciting Frontiers

(85:19–end)

• Gene therapies for congenital deafness, multiple myeloma breakthroughs, ALS, universal flu vaccines, even PTSD treatments on the immediate horizon.
• FDA’s focus: act at patient speed, not “government speed”; grant priority vouchers for breakthrough innovations.
• Makary:

  “We have got to move at the speed that my patients demanded, not at government speed.” (88:45)

Notable Quotes & Memorable Moments

• On COVID-era dogma:

  “Cloth masks on toddlers…vaccine mandates for young college students…ignoring natural immunity—one of the most scientifically dishonest things a scientist could possibly say…” (01:30)

• On FDA reform:

  “We are doing it with new programs, new priority reviews, new pilots, new forms of transparency…We made our rejection letters public…” (04:18)

• On China:

  “We were getting clocked by China…we need to rethink our entire phase 1 process.” (08:57)

• On Safety vs. Speed:

  "Time delays that are unnecessary have risks...you may be holding back a curative medication for eight months." (24:31)

• On the food pyramid:

  “Nutrition science may be one of the most corrupted fields in all of science…it gave us the dogma that we had to focus on saturated fat and just eradicating natural healthy fats.” (33:27)

• On over-the-counter drug access:

  "We want to see a mass transition to more non prescription drugs...if your drug does not have abuse potential, if your drug is safe...[it] should be able to be over the counter." (1:04:41)

• On vaccine schedule:

  “There’s a consensus of a group of core essential vaccines...the idea is to increase vaccination rates among children that have been dropping because of a loss in public trust…” (51:31)

• On scientific humility:

  "During COVID the right answer many times was, we don't know...the right answer was 'we don't know.'" (58:09)

• On frontier science:

  “I would like to see…a cure for type 1 diabetes…a powerful treatment for ALS…a universal flu shot…And I'd like to see something powerful for PTSD.” (85:24)

Key Timestamps

• 00:31–03:21 — Makary’s background, COVID philosophy, appointment
• 03:21–07:50 — Institutional reform, pushback, culture at FDA
• 07:50–11:30 — U.S.-China biotech race, global competitiveness
• 13:14–18:19 — Drug approval reform, animal testing, computational models
• 19:19–23:19 — AI, Bayesian statistics, continuous monitoring, post-market safety
• 23:19–25:23 — Risks of regulatory delay, speed vs. safety
• 25:23–29:17 — Right to Try, cell/gene therapy regulation
• 31:13–33:12 — Digitization, organizational overhaul stories
• 33:12–41:02 — Food pyramid, nutrition science, root cause focus
• 41:02–44:19 — Obesity, GLP-1 drugs, systemic health failures
• 44:19–49:54 — NIH funding, research priorities, “anti-science” critiques
• 49:54–58:29 — Vaccine reform, trust, schedule alignment, humility
• 59:14–66:41 — Drug pricing, biosimilars, over-the-counter expansion
• 66:41–73:24 — Insurance for OTC, TV pharma advertising, AI & diagnostics
• 73:49–78:39 — Alternative proteins, GRAS, cell-cultured foods
• 78:56–83:49 — Autism, microbiome, environmental contributors
• 85:19–end — Exciting therapeutic frontiers, gene therapy stories, closing remarks

Tone and Language

Makary speaks with conviction, clear data references, skepticism toward medical dogma, and a practical, deeply empathetic stance toward patient experience. Friedberg probes with informed, sometimes contrarian questions, maintaining a collegial, evidence-based tone throughout.

Summary for the Uninitiated

This episode provides a detailed, inside look at the radical shakeup in FDA operations under Dr. Marty Makary. Covering everything from COVID-era lessons, biotech competition with China, reforming how drugs and food are regulated, to improving healthcare affordability and rebuilding public trust, it’s a must-listen for anyone interested in the future of medicine, government transparency, and science-driven health policy.