Overview of 659. Can Marty Makary Fix the F.D.A.?
This Freakonomics Radio interview (host Stephen Dubner) features Marty Makary, the Food and Drug Administration commissioner, discussing his priorities and reforms for the FDA: speeding drug approvals, modernizing regulatory processes (including AI), redefining food guidance, reducing unnecessary testing (e.g., animal testing), increasing transparency, and using market incentives to lower drug prices. The conversation also covers recent controversial moves—most notably a White House announcement linking prenatal acetaminophen to autism and the FDA’s label change for leucovorin as a potential autism treatment—and broader tensions between science, politics, and public messaging.
Topics discussed
- Makary’s transition from surgical oncologist/academic to FDA commissioner and his management approach (diagnose before prescribing changes; challenge dogma).
- Examples of “medical dogma” gone wrong: historical peanut avoidance, demonization of saturated fat, and sugar’s role in cardiometabolic disease.
- FDA reform agenda:
- Speeding and streamlining drug/device review processes (reduce multi-office bureaucracy; convene offices to produce decisions faster).
- Using AI internally (ELSA) to help reviewers process massive applications.
- Making decision letters public for transparency.
- Incentivizing lower drug prices via regulatory prioritization for companies offering “most favored nation” pricing.
- Reducing animal testing and adopting organ-on-a-chip/computational models.
- Surprise overseas inspections and incentives for domestic manufacturing.
- Revising food guidance (rewriting the food pyramid, removing petroleum-based dyes, defining ultra-processed foods, SNAP waivers).
- Redefining baby formula regulation to spur innovation.
- Specific clinical/therapeutic areas Makary highlighted as priorities: cures or meaningful treatments for type 1 diabetes, certain early-stage cancers, neurodegenerative diseases, PTSD treatments, and a universal/long-lasting flu vaccine.
- Recent policy moves and controversies:
- Leucovorin label change to include a possible indication for some autism subgroups (cerebral folate deficiency).
- Public remarks and FDA guidance about prenatal acetaminophen (Tylenol) and autism risk.
- Direct-to-consumer drug advertising and the administration’s instruction to curb deceptive ads.
- Relationship with HHS Secretary Robert F. Kennedy Jr. and broader political context under the second Trump administration.
- Funding and research: Makary’s assertions about NIH/Medicaid budgets and the media’s portrayal of cuts.
Main takeaways
- Makary’s top-line goal: modernize the FDA to deliver more cures and healthier food faster while maintaining scientific independence on safety/efficacy.
- Operational reforms are focused on cutting bureaucratic friction (reduce review timelines from years to weeks where appropriate) and leveraging technology (AI, big data).
- Policy levers include both regulatory reform and economic incentives (e.g., priority review vouchers for pricing commitments, manufacturing location).
- The FDA under Makary is pursuing some controversial, faster-moving policies (e.g., leucovorin label change) that trade a lower evidentiary bar in favor of access when safety profiles are strong and unmet need is high.
- Makary frames many changes as correcting longstanding “dogmas” and regulatory inertia; he emphasizes transparency and partnership with industry while asserting independence in scientific assessments.
Notable quotes / insights
- “Challenge deeply held assumptions, make a diagnosis before recommending any treatment option or change.”
- “We’re not going to be stingy librarians. We’re going to go into the pipeline, find out what sounds promising and bring that to the forefront.”
- On internal AI use: FDA reviewers found ELSA improved handling of extremely large applications (organizing content, formatting checks).
- On politicization of science: Makary used the phrase “Trump derangement syndrome” to describe reflexive opposition he sees from some critics.
Evidence & concrete examples cited in the episode
- Leucovorin (a long-used, generic folate supplement) — Makary says clinical and observational studies suggest benefit for some autistic children with cerebral folate deficiencies; NIH grants were announced to track subgroup effects.
- Type 1 diabetes — Makary references lab-grown beta cells and islet transplantation advances as a realistic near-term target.
- Baby “KJ” case at Children’s Hospital of Pennsylvania — described as an example of expedited, individualized gene therapy access.
- Organ-on-a-chip and computational models — presented as superior to animal tests for many drug candidates; FDA roadmap to phase out animal testing category-by-category (monoclonal antibodies highlighted).
Controversies, caveats, and fact-check notes
- Leucovorin and autism: Makary argues safety + some clinical data justify label changes and access for clinicians. Many scientists caution evidence is preliminary and benefit is likely limited to specific subgroups.
- Acetaminophen (prenatal) and autism: Makary and the administration publicized an association; FDA’s “Dear Doctor” letter noted association but emphasized no established causal relationship and mixed study results. Media coverage and political rhetoric amplified and simplified the message, causing confusion.
- NIH and Medicaid funding claims: Makary stated the NIH budget and Medicaid funding are not cut. Independent context:
- The administration proposed an $18 billion cut to NIH for 2026 (Congress later rejected the proposed cut); however, implementation of certain budgetary changes and program adjustments has disrupted research activity.
- The Congressional Budget Office and other analyses indicate proposed reforms to Medicaid funding would reduce federal Medicaid spending relative to baseline projections over time; headline increases year-to-year may mask proposed structural cuts.
- Bottom line: statements about “no cuts” are contested and depend on budget baseline, timing, and what counts as reallocated vs. cut funds.
- Political context: The administration’s HHS leadership (Robert F. Kennedy Jr.) is controversial; some scientific and medical communities criticize policy choices and public messaging. Makary emphasizes openness to scientific questioning, while critics see partisan or unorthodox positions.
Practical implications & what to watch next
- For patients and clinicians:
- Expect faster regulatory reviews for drugs/devices that meet the FDA’s prioritized criteria (unmet need, U.S. manufacturing, price commitments).
- Greater transparency: public decision letters could help clinicians and innovators understand FDA reasoning.
- New or repurposed treatments (e.g., leucovorin in specific autism subgroups) may become more visible while targeted research continues.
- For industry:
- Economic incentives (pricing commitments) may become an explicit path to priority review—companies should watch regulatory guidance and consider strategic pricing/commitments.
- AI tools and streamlined submission expectations may change how dossiers are prepared and reviewed.
- For advocates and journalists:
- Expect continued debate and intense media coverage around FDA decisions that sit at the intersection of science, public health, and politics. Scrutinize evidence levels and track follow-up studies/grants (e.g., NIH-funded research into leucovorin).
Further listening / references from the episode
- Previous Freakonomics episodes with Makary:
- Episode 456 — How to Fix the Hot Mess of U.S. Healthcare
- Episode 270 — Bad Medicine Part 3, Death by Diagnosis
- Episode 617 — Are You Really Allergic to Penicillin? (related to immune tolerance discussion)
- Note: podcast release was delayed by a government shutdown; the interview took place in October.
If you want to focus on any single theme from this interview (FDA speed vs. safety, leucovorin/autism evidence, AI in regulatory review, or FDA transparency), I can produce a deeper, shorter briefing summarizing the specific scientific and policy evidence.