Freakonomics Radio Episode 659: Can Marty Makary Fix the F.D.A?
Host: Stephen J. Dubner
Guest: Dr. Marty Makary, FDA Commissioner
Date: January 16, 2026
Episode Overview
This episode explores the ambitious vision and controversial reforms of Dr. Marty Makary, the newly appointed FDA Commissioner under the second Trump administration. Host Stephen Dubner interviews Makary about his bold attempts to modernize the FDA, including changes to drug approval, food regulation, labeling practices, and the handling of medical controversies under politically charged circumstances. The conversation is both a deep dive into policy and a candid look at the challenges of leading a massive regulatory agency in an era of intense polarization.
Key Discussion Points and Insights
1. Marty Makary’s Transition and Philosophy
- Clinical to Regulatory: Makary describes his move from surgical oncologist and policy researcher to a high-profile regulatory role as “a very different life,” but sees some core principles carrying over—like challenging dogma and making diagnoses before offering treatments (04:47).
- Challenging Dogma: He repeatedly criticizes medical dogmas that led to public health missteps, e.g., delayed peanut exposure (linked to increased allergies) and the demonization of saturated fat over sugar (05:51, 07:58).
- Quote:
“By going in hard with dogma and no data, it became this perpetual vicious cycle…”
— Makary, 06:40
- Quote:
2. Regulatory Capture and Industry Influence
- Makary cites the FDA’s problematic history approving OxyContin as "a moment in FDA's history where it was captured by the industry it was supposed to regulate" (07:00).
- Aims to close the “revolving door” between regulators and industry.
3. Price Transparency and Healthcare Economics
- Makary explains his earlier role in advocating for hospital and drug price transparency, helping shape executive orders in the first Trump administration (09:08).
- Collaborates with other health agency heads (including Mehmet Oz at CMS and Jay Bhattacharya at NIH) to use incentives (e.g., Most Favored Nation pricing, priority review vouchers) to lower US drug prices (11:55).
- Quote:
“We’re using market incentives essentially to create incentives for companies to lower their prices.”
— Makary, 12:05
4. Modernizing FDA: Overregulation, Bureaucracy, and Reform
- The FDA regulates 20% of the US economy, but faces issues of overregulation and bureaucratic delay (13:26).
- Drug approval timelines are being radically re-examined to avoid needless delays; the approval process is being redesigned “from A to Z” (14:24).
- Quote:
“It does not make sense to me that we put you through a long, arduous process... when we can probably make basic assessments on safety in a year or two.”
— Makary, 13:50
- Quote:
5. Policy Initiatives and Achievements
- Makary lists many in-progress reforms:
- AI Integration: Developing internal AI tools (“ELSA”) to help scientific reviewers process vast, complex applications (18:57).
- Food Policy: Removing petroleum-based food dyes, rewriting the food pyramid, defining “ultra-processed foods,” associating SNAP waivers with healthier options (16:22).
- Transparency: Publishing decision letters publicly for accountability (16:22).
- Eliminating Animal Testing: Phasing in organ-on-a-chip alternatives, especially for monoclonal antibodies (41:22).
- Speeding Drug Approvals: Moving from year-long to week-long review cycles in some cases (16:22).
- Encouraging Domestic Manufacturing: Preferential review for drugs made in the U.S. (16:22).
- Incentivizing Lower Prices: Priority reviews for companies offering world-competitive pricing (16:22, 55:59).
- Example Initiatives: Fast-tracking a gene therapy for a child with a rare disorder (26:05).
6. Major Controversies Covered
-
Leucovorin for Autism: Makary approved label updates for leucovorin (originally for cancer) to include some cases of autism, based on emerging data, despite the lack of full consensus (29:47).
- Quote:
“We said, this is not a silver bullet. ... But we were at a point now... [where] there is sufficient evidence on leucovorin…”
— Makary, 30:30
- Quote:
-
Tylenol (Acetaminophen) in Pregnancy: The FDA issued new guidance on acetaminophen use in pregnancy due to possible (but not definitive) associations with autism, sparking media controversy (29:47).
- Makary authored a nuanced “Dear Doctor” letter (36:43).
- He criticizes media for oversimplifying or misrepresenting nuanced medical guidance (37:29).
- Quote:
“There are exceptions that sometimes a woman needs to take it, and that ultimately it’s between an individual and their doctor. Those points were left out entirely in our politically charged media landscape.”
— Makary, 37:47
-
Direct-to-Consumer Pharma Ads: Makary discusses plans to regulate deceptive drug advertising and questions broader US policy of allowing pharma ads (39:42).
- Quote:
“You don't even know what it’s for… and you might hear a long list of side effects, and you say ‘wait a minute, did they just say sudden death as a complication?’”
— Makary, 40:00
- Quote:
-
Birth Control and Abortion Pills: Maintains that the FDA acts independently and decisions remain scientific, regardless of political pressure (44:25).
7. Funding and Political Disputes
- Makary challenges reports of NIH/Medicaid funding cuts, says increases have occurred but are spun as cuts due to partisan framing (45:29, 46:33).
- Dubner adds context—administration proposals did target major cuts, but Congress blocked them. Some research was disrupted (48:02).
8. Politics, Science, and partisanship
- Makary invokes “Trump Derangement Syndrome” to describe critics who he believes reflexively attack Trump-era policies regardless of substance (53:41).
- Advises focusing on evidence and remaining scientifically objective despite polarization (55:43).
9. Looking Ahead: The FDA Reform Vision
- Makary emphasizes using AI, incentives, deregulation, and transparency to modernize the FDA (55:59).
- Advocates for aligning public health aims with economic incentives: “We can use economic incentives to actually advance public health by leaps and bounds.” (55:59)
- Claims increasing morale, big hiring wave at FDA, and culture of improvement (57:47).
Notable Quotes & Memorable Moments
-
On Medical Dogma:
“The medical establishment locked arms and walked off a cliff together and declared natural saturated fat the enemy of public health. We now know they got it wrong.”
— Makary, 07:58 -
On AI at the FDA:
“We have created a powerful AI tool that our scientific reviewers can use...”
— Makary, 21:17 -
On Drug Adverts:
“You don't even know what it’s for... and you might hear a long list of side effects, and you say, ‘Did they just say sudden death as a complication?’”
— Makary, 40:00 -
On Role of FDA and Public Perception:
“If literally we had discovered and announced the cure for cancer, you would have some people say, well, the Trump administration interfered. They did this too quick, they did it too slow.”
— Makary, 03:39 & 53:45
Timestamps for Key Segments
- Opening, Makary’s Background and Philosophy: 03:10
- Medical Dogma & Peanut Allergy Example: 05:51
- FDA’s OxyContin Failure: 07:00
- Food Policy Reform (Saturated Fats, Food Pyramid): 07:58
- Path to FDA Commissioner & Price Transparency: 09:08
- Drug Price Incentives: 11:55
- FDA Bureaucracy & Drug Approval Lag: 13:26, 14:24
- Comprehensive Policy List: 16:22
- FDA’s Use of AI (“ELSA”): 18:57, 21:17
- Ambitions for FDA – More Drug Approvals, Cures: 22:46
- Example: Beta Cell Transplant for Type 1 Diabetes: 26:05
- Leucovorin for Autism Label Change: 29:47
- Acetaminophen/Tylenol Controversy: 35:09
- Direct-To-Consumer Drug Ads: 39:42
- Organ-on-a-chip and Eliminating Animal Testing: 41:22
- Abortion Pill Policy: 44:25
- Funding Controversies (NIH, Medicaid): 45:29, 46:33
- Media, Politics, and 'Trump Derangement Syndrome': 53:41, 55:43
- FDA Vision and Morale: 55:59, 57:47
Tone and Language
Makary is forthright, occasionally humorous, and unafraid to criticize both the medical establishment’s past errors and the current media landscape. Dubner, as always, is probing, sometimes skeptical, but seeks clarity and evidence. The episode combines technical insight, policy wonkery, and political candor, reflecting both the gravity and controversy surrounding U.S. healthcare regulation today.
Conclusion
This episode is a comprehensive (and, at times, contentious) overview of the FDA’s direction and internal culture under Dr. Makary: a leader determined to shake off bureaucratic inertia, lean into incentives and transparency, and move faster toward meaningful cures—even while navigating volatile political waters and public mistrust. The conversation highlights both the opportunities and the perils embedded in reforming an institution central to American health and safety.
For listeners seeking more depth:
- “How to Fix the Hot Mess of US Healthcare” (Ep. 456)
- “Bad Medicine Part 3: Death by Diagnosis” (Ep. 270)
- “Are You Really Allergic to Penicillin?” (Ep. 617)
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