Morning Wire – From Diet to Drugs: Inside HHS’s Push for Bold Reforms

Date: September 27, 2025
Hosts: John Bickley, Georgia Howe
Guest: Dr. Marty Makary, FDA Commissioner

Episode Overview

This episode features an in-depth conversation with Dr. Marty Makary, the new FDA Commissioner, about sweeping reform efforts at the Department of Health and Human Services (HHS) and the FDA. The discussion centers on two major topics: a groundbreaking federal announcement about a possible cause and new treatment for autism, and broader FDA policy shifts aimed at modernizing drug approvals, food safety, and public health in the U.S.

Key Discussion Points & Insights

1. The FDA’s Groundbreaking Autism Announcement

• Potential Cause Identified
  • FDA is warning about risks associated with acetaminophen use during pregnancy due to strong evidence suggesting a link to autism.
  • Citing large studies and statements from leading institutions like Harvard School of Public Health asserting the association may be causal.
• Immediate FDA Actions
  • Moving to change acetaminophen warning labels.
  • Communication to practitioners via a "Dear Doctor" letter.
  • Emphasis on err(ing) on the side of safety due to the rise in autism and lack of other known causes.

Notable Quote:

“We are letting people know about the potential risks of acetaminophen in pregnancy. There have been large studies linking that medication to autism in children subsequently.”
— Dr. Marty Makary [02:12]

Timestamps:

• [02:04] Announcement explanation
• [03:25] Discussion about timing, dosage, and evidence

2. New Treatment Possibilities for Autism

• Treatment Overview
  • Emerging research suggests the use of leucovorin (vitamin B6) or related vitamin therapies for certain children with autism who have an underlying autoimmune condition.
  • The working theory: some children have antibodies that block folate receptors in the brain, preventing folate from supporting neurodevelopment.
• Novelty & Mechanism
  • Doctors can test for folate antibodies; if positive, children may benefit from vitamin therapies that bypass the blocked receptors.

Notable Quote:

“Some kids with autism actually have an autoimmune disease... the body is creating antibodies that block the folate receptors on their brain.”
— Dr. Marty Makary [04:23]

Timestamps:

• [04:11] Introduction to new treatment
• [05:10] Mechanism and clinical approach

3. Addressing Controversies in Autism and Science Policy

• Openness in Scientific Inquiry
  • Dr. Makary highlights public distrust due to "sacred cow topics" and politicization of science.
  • The current HHS/FDA approach is to “go bold” and pursue scientific truth, regardless of pressure from lobbying or traditional taboos.

Notable Quote:

“The purpose of science itself is to investigate questions. We’ve got blind spots. There are sacred cow topics we’re not supposed to talk about.”
— Dr. Marty Makary [05:31]

Timestamps:

• [05:31] Fakt and fiction in autism controversies
• [06:25] On embracing bold science

4. Dr. Makary’s Top FDA Reform Goals

• Streamlined Drug Approvals
  • Drastically reducing decision timelines from years to weeks.
  • Prioritizing drugs that lower healthcare utilization, are manufactured in the U.S., or meet urgent public health needs.
• Food Safety and Nutrition Initiatives
  • Significant cooperation with the food industry to remove harmful additives such as titanium dioxide, high fructose corn syrup, and BHT.
  • Implementation of first-ever waivers for SNAP (food stamp) programs to disallow purchases of unhealthy foods and sugary drinks.
• Innovative Testing & Fast-Track Cures
  • Moving away from animal testing toward computational modeling and AI.
  • Accelerated pursuit of cures for Type 1 diabetes, neurodegenerative diseases, certain cancers, and PTSD.
  • Commitment to swiftly address the veteran suicide crisis via fast-tracked treatment approvals.

Notable Quote:

“We have streamlined the approval process at the FDA so we can get a decision out in weeks instead of a year.”
— Dr. Marty Makary [06:34]

Timestamps:

• [06:25] FDA reform priorities
• [07:00] Food safety efforts
• [08:00] Animal testing & new cures
• [08:23] PTSD and veteran health

5. Reforming U.S. Regulations on Sunscreen and Other Health Products

• Opening Access to International Products
  • Dr. Makary indicates FDA is tackling outdated paternalistic policies that limit access to safer or more effective products widely used abroad.
  • The goal is to modernize and simplify overly restrictive approval pathways.

Notable Quote:

“We are going to open that up, Georgia… One of those [problems] is the remnant paternalistic approach to medicine.”
— Dr. Marty Makary [08:57]

Timestamps:

• [08:39] Sunscreen ingredient access and regulatory reform

Memorable Moments

• Dr. Makary’s announcement that he, Jay Bhattacharya, and Dr. Oz are directly charged by President Trump to be bold in “doing what's right scientifically and not worry about lobbyists and corporations.” [06:05]
• Candid inside look at the state of the FDA upon his arrival: “First of all, it was a mess… We found a lot of broken processes and it’s going to take some time.” [08:57]

Conclusion

This episode gives listeners an unprecedented inside view into the FDA’s bold new agenda, revealing major changes at the intersection of public health, drug and food regulation, and scientific openness. Dr. Makary’s explanations are clear and candid, offering both hope for families affected by autism and reassurance that the FDA will operate with greater speed, transparency, and integrity in the years ahead.