Freakonomics Radio

659. Can Marty Makary Fix the F.D.A.?

January 16, 2026

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  • FDA Commissioner Marty Makary aims to modernize the agency by proactively engaging with the drug pipeline, cutting bureaucratic red tape to speed up approvals, and using market incentives like priority review vouchers to lower drug prices. 
  • Makary identifies historical 'patterns of dogma' in medicine, citing the reversal of peanut allergy avoidance guidelines and the sugar industry's successful demonization of natural saturated fat, as examples of flawed regulatory thinking he seeks to correct. 
  • The FDA under Makary is aggressively pursuing ambitious public health goals, including accelerating treatments for Type 1 diabetes and PTSD, while also modernizing regulation of AI software and eliminating animal testing requirements where possible. 

Segments

FDA Commissioner Marty Makary Interview
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(00:01:08)
  • Key Takeaway: The FDA under Marty Makary is shifting from a passive role to proactively engaging with the drug development pipeline.
  • Summary: The introduction sets the stage by mentioning recent controversial public health actions under HHS Secretary Robert F. Kennedy Jr. and then introduces FDA Commissioner Marty Makary, noting his background as a surgical oncologist and his goal to make the FDA less passive and more proactive in bringing promising treatments forward.
Makary’s Transition and Dogma Challenge
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(00:04:16)
  • Key Takeaway: Makary applies his surgical oncologist principle of challenging deeply held assumptions to his role at the FDA.
  • Summary: Makary discusses the adjustment from clinical practice to government regulation, emphasizing his approach of challenging dogma and making a diagnosis before recommending treatment, referencing his book ‘Blind Spots’.
Challenging Medical Dogma: Peanut Allergies
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(00:05:42)
  • Key Takeaway: Medical dogma, such as advising against early peanut exposure, created the modern peanut allergy epidemic by ignoring immune tolerance principles.
  • Summary: Makary explains how the American Academy of Pediatrics’ dogma against early peanut exposure led to an epidemic, contrasting it with the scientific understanding that early exposure builds immune tolerance.
FDA’s OxyContin Approval Failure
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(00:06:42)
  • Key Takeaway: The approval of OxyContin for chronic pain is cited as a historical low point where the FDA was ‘captured’ by industry interests.
  • Summary: Makary discusses the FDA’s approval of OxyContin based on a short study and notes the regulator involved later worked for the company, highlighting the revolving door issue.
Sugar Industry vs. Fat Dogma
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(00:07:36)
  • Key Takeaway: The medical establishment wrongly demonized natural saturated fat, leading to increased sugar and refined carbohydrate consumption, which the FDA is now working to correct.
  • Summary: Makary addresses the dogma that saturated fat causes heart disease, explaining how this led to the promotion of low-fat, high-sugar foods, and states the FDA is rewriting the food pyramid to end the ‘war on natural saturated fat’.
Path to Becoming FDA Commissioner
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(00:08:46)
  • Key Takeaway: Makary’s advocacy for healthcare price transparency led to relationships with the White House, opening the door for his FDA appointment.
  • Summary: Makary details his apolitical background and how his work on hospital and drug price transparency during the first Trump administration led to his invitation to run the FDA, a role he was eager to take.
FDA Priorities: Drug Prices and Innovation
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(00:10:58)
  • Key Takeaway: The FDA is using market incentives, like priority review vouchers, to encourage drug companies to lower prices to be comparable with other developed nations.
  • Summary: Makary confirms that lowering drug prices and addressing inappropriate care remain priorities. He explains the FDA’s strategy of offering priority review in exchange for companies agreeing to ‘most favored nation’ pricing.
FDA Remit and Over-Regulation
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(00:12:29)
  • Key Takeaway: Makary believes the FDA suffers from both over-regulation and under-regulation, but over-regulation and regulatory creep dominate, slowing down drug approval significantly.
  • Summary: Makary discusses the FDA’s broad remit (20% of the economy) and his goal to deregulate and challenge the 10-12 year timeline for new drug approval.
Streamlining Drug Approval Process
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(00:14:07)
  • Key Takeaway: The drug approval process has become slow due to massive, complex applications and bureaucratic farming out of review tasks, which Makary is redesigning.
  • Summary: Makary describes how applications ballooned to over 100,000 pages, leading to bureaucratic delays, and outlines efforts to redesign the process to deliver answers in weeks instead of a year.
Makary’s Key Modernization Goals
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(00:16:01)
  • Key Takeaway: Makary’s main goal is to modernize the FDA to deliver more cures, healthier food, and eliminate animal testing requirements.
  • Summary: Makary lists priorities including integrating AI, removing petroleum-based food dyes, rewriting the food pyramid, eliminating animal testing, using big data for post-approval safety, and making decision letters public.
Applying AI at the FDA
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(00:18:04)
  • Key Takeaway: The FDA is using an internal AI tool, ELSA, to help scientific reviewers organize massive applications, improving efficiency.
  • Summary: Makary discusses the need to modernize regulation of AI software and how the FDA’s internal tool, ELSA, is being voluntarily used by thousands of reviewers to organize complex applications.
Goals for Future Drug Approvals
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(00:22:07)
  • Key Takeaway: Makary aims for more meaningful drug approvals, targeting cures for Type 1 diabetes, neurodegenerative disorders, and cancer, alongside a universal flu shot.
  • Summary: Makary believes increasing the number of meaningful drug approvals is a healthy goal, specifically mentioning breakthroughs for chronic diseases and PTSD treatments for veterans.
Accelerating Cures: Type 1 Diabetes Example
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(00:24:31)
  • Key Takeaway: The FDA is proactively seeking out promising early-stage research, such as lab-grown beta cells for Type 1 diabetes, to facilitate regulatory pathways.
  • Summary: Makary discusses proactive engagement with scientific reviewers to identify promising pipeline treatments, citing the potential for lab-grown, transplantable beta cells for diabetes.
Leukovorin for Autism Treatment
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(00:30:46)
  • Key Takeaway: The FDA approved a label change for the generic drug leukovorin to treat a subgroup of children with autism who have blocked folate receptors.
  • Summary: Makary explains the rationale behind approving leukovorin for autism, noting its long safety profile and its ability to bypass blocked folate receptors in the brain for some patients.
Acetaminophen/Tylenol Controversy
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(00:35:49)
  • Key Takeaway: The mixed evidence regarding prenatal acetaminophen use led to a nuanced FDA letter that was oversimplified by media coverage of the President’s announcement.
  • Summary: Makary addresses the Tylenol controversy, noting that while the research was mixed, the Dean of Harvard School of Public Health weighed in strongly, leading to the FDA’s cautionary letter.
DTC Drug Advertising Scrutiny
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(00:39:46)
  • Key Takeaway: The FDA is targeting deceptive direct-to-consumer pharmaceutical ads, especially those online, that fail to provide an adequate balance of side effects.
  • Summary: Makary discusses the directive to target deceptive ads, noting that some ads, particularly online, feature no spoken words or side effects, which violates the requirement for balanced information.
Organ-on-a-Chip Technology
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(00:42:02)
  • Key Takeaway: Organ-on-a-chip technology and computational modeling are superior predictors of human drug response than traditional animal testing, which the FDA is moving to eliminate requirements for.
  • Summary: Makary highlights that 90% of drugs fail human trials after passing animal tests, making alternatives like organ-on-a-chip technology a necessary upgrade, especially given the ethical concerns of animal testing.
FDA Independence and Political Pressure
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(00:44:58)
  • Key Takeaway: The FDA remains an independent scientific organization that follows the law, engaging in scientific dialogue with political leaders but making decisions based on data.
  • Summary: When asked about potential political interference regarding abortion medication, Makary affirms the FDA’s independence and commitment to scientific dialogue, stating they have no plans to change approvals for those drugs.
Partisan Media and NIH Funding
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(00:46:03)
  • Key Takeaway: Makary asserts that media reports of NIH budget cuts are false, claiming partisan reporting misconstrued proposals to shift funding from DEI studies to actual cures.
  • Summary: Makary strongly refutes claims of NIH budget cuts, arguing that partisan media misrepresented a proposal to redirect funds from descriptive DEI studies toward research on specific diseases.
Aligning with HHS Secretary Kennedy Jr.
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(00:51:07)
  • Key Takeaway: Makary supports Secretary Kennedy Jr. asking ‘big questions’ because suppressing inquiry is a step backward scientifically, provided the final conclusions are based on further study.
  • Summary: Makary defends the Secretary’s controversial inquiries, stating that scientific progress requires openness to challenging hypotheses through further study, not censorship.
Addressing ‘Trump Derangement Syndrome’
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(00:53:00)
  • Key Takeaway: Makary attributes much of the current polarization to ‘Trump derangement syndrome’ and the politicalization of science during COVID-19, urging objectivity based on clinical data.
  • Summary: Makary argues that some critics are contrarian regardless of the facts, pointing to the politicalization of science during COVID where medical societies allegedly flipped positions based on which party was in power.
Operationalizing Public Health Incentives
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(00:56:15)
  • Key Takeaway: The FDA is using economic incentives—domestic manufacturing, addressing unmet needs, and lower prices—to move promising drug applications to the front of the line.
  • Summary: Makary reiterates that the FDA can partner with industry operationally to streamline the user interface, prioritizing applications that benefit national security (domestic manufacturing) or public health needs.