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

Summary

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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

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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.

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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

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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

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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

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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

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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

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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]

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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.

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Transcript

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[Dr. Marty Makary]

Dr. Marty Makary has entered the FDA as its new commissioner amid sweeping changes and groundbreaking findings.

[Georgia Howe]

In this episode, Dr. Makary explains the science behind the administration's announcement earlier this week about a potential cause for autism. I'm Georgia Howe with Daily Wire executive editor John Bickley, and this is a weekend edition of Morning Wire.

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[Georgia Howe]

Joining us now to discuss is FDA commissioner and longtime Morning Wire contributor Dr. Marty Makary. Dr. Makary, thanks so much for coming on.

[Dr. Marty Makary]

Good to be with you, Georgia.

[Georgia Howe]

So we had a very significant announcement this week regarding autism research. Tell us first, what was that announcement and then what's the FDA's role going to be?

[Dr. Marty Makary]

So we're taking autism very seriously and identified a potential cause that we're letting the public know about and a potential treatment that hundreds of thousands of kids with severe autism would likely qualify for. And that is 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. And so we are going to start the process to change the label. And I've sent a Dear doctor letter to all us physicians letting them know about the association because we, we now have good data from large studies. And the Harvard School of Public Health Dean has made a very conclusive statement that he believes the association is causal. So when you have that weight of evidence, you have to take it seriously and err on the side of safety. Especially since the vast majority of low grade fevers do not need to be treated as we reflexively did in medical school and in training.

[Georgia Howe]

Does it matter when in the pregnancy it was? Is it dose dependent? Is it like long term use? What are they seeing in the data?

[Dr. Marty Makary]

Well, there are associations between the duration of acetaminophen use and the risk of autism in children subsequently, as well as the proximity to the time of birth. There's been acetaminophen that's shown up in the cord blood of newborn babies and that cord blood level has been associated with the degree of risk. So there's enough evidence here for us to say, hey, we don't need a 10 year randomized controlled trial. We have an epidemic of autism that has increased 400% in the recent decades and we don't have a known cause. Now this may be a cause, but when you have enough evidence to suggest an association and you have no other plausible cause, we have a duty to notify parents and doctors.

[Georgia Howe]

Now you mentioned there's also a new treatment being discussed. Tell us about that new treatment, who it could work for and what the mechanism is, just in a broad general way.

[Dr. Marty Makary]

The treatment is called leucovorin or vitamin B6. It's been around for nearly a century, but only recently have we recognized that some kids with autism actually have an autoimmune disease. The mechanism may be that the body is creating antibodies that block the folate receptors on their brain, restricting the ability of folate to get into the cerebrum. And so what that does is it actually creates a situation where you could have high levels of folate in your diet or in your blood, but it's not getting in the brain. And some doctors have actually started to test for this folate antibody and they will then move on to treat some kids with this folinic Acid or vitamin B12 that bypasses the receptor.

[Georgia Howe]

Now there's been a lot of controversy about HHS in particular taking on autism. They'll talk about the, how vaccines are completely safe, et cetera, et cetera. What do you make of the controversies and can you separate some of the fact from fiction with regards to what the public believes about how you guys are approaching this?

[Dr. Marty Makary]

Look, Secretary Kennedy is asking questions that the American people are asking. And so we have this odd new political landscape that's penetrated science where you're supposedly not allowed to ask certain questions. It's created a tremendous amount of distrust. But I can tell you 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. Well, Dr. Jay Bhattacharya, Dr. Oz and myself, we come from very respected institutions, Stanford, Columbia and Johns Hopkins. We're using the scientific method to try to tackle the big questions that are put in front of us. We're using gold standard science and common sense. And we have a direct charge from President Trump to go bold, do what's right scientifically and not worry about the lobbyists and the corporations zooming out a little bit.

[Georgia Howe]

You just took a helm at the fda. What are your say top three goals there and what could we see change under your leadership?

[Dr. Marty Makary]

Well, look, Georgia, I want to see more cures for the American people and I want to see healthier food for children. We've taken huge steps in both of those areas. We have streamlined the approval process at the FDA so we can get a decision out in weeks instead of a year. We're going to prioritize drugs that reduce downstream healthcare utilization that where the drug is made in the United States for a national security issue and anything that meets a large unmet public health need. We are also seeing tremendous cooperation now from the food industry on our goals, not just to remove the non petroleum based food dyes, but the next tier of chemicals. We've seen companies remove titanium dioxide. We've seen just last week Tyson, one of the largest food manufacturers in the United States, agreed to remove all high fructose corn syrup and titanium dioxide and bht, a preservative where there are health concerns. So we're seeing tremendous strides in healthier food for children. We've seen the first ever SNAP program waivers so that states don't have to use taxpayer dollars for junk food and sugary drinks. And we're going to keep going. We're we've also launched a series of initiatives to eliminate animal testing requirements at the fda, to use more AI and computational modeling and to deliver more cures. I'd like to see a Cure for type 1 diabetes or a meaningful treatment in the next couple years. And I think you're going to see it for neurodegenerative diseases that are otherwise hopeless and disabling for certain types of cancer. Stage 1 and 2 GI cancers in going to see a powerful treatment in my opinion likely come out soon in those areas. And for PTSD, we still lose 8,000 veterans a year to suicide. We lose more veterans a year to suicide than we did the entire Afghan and Iraq wars. We owe it to them to get a decision out quickly from the FDA on potentially promising therapies for ptsd. And we're going to do that.

[Georgia Howe]

Other countries have all these SPF or have all these sun protective chemicals that we're not allowed to have. Other comparable countries have like 54 chemicals they're allowed to use. They have much more elegant formulas, but we have a very limited amount of chemicals that we're allowed to have here. Do you see that opening up anytime soon?

[Dr. Marty Makary]

Yeah, we are going to open that up, Georgia, because what we see at the FDA when we walked in there, first of all, it was a mess. They were approving drugs where the cells of Americans were sent to China for gene editing and then sent back to the US for infusion in American patients. We found a lot of broken processes and it's going to take some time. But one of those is the remnant paternalistic approach to medicine. That is, we can't allow you to try certain sunscreens used in Europe because we have to decide first that they're safe for you. And many of those processes are deep in regulation. They create these cookbooks or recipes at the FDA and, and say if you don't follow this exact recipe, then you can't have a product on the US Market. And so we're taking that head on.

[Georgia Howe]

All right, well, thank you so much for coming on today.

[Dr. Marty Makary]

Good to be with you, Georgia.

[Georgia Howe]

That was FDA Commissioner Dr. Marty Makary and this has been a weekend edition of Morning Wire.

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