The Hormone Reset: FDA’s New Approach to Women’s Medicine

Summary

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Morning Wire – “The Hormone Reset: FDA’s New Approach to Women’s Medicine”

Date: November 22, 2025
Hosts: Georgia Howe, John Bickley
Guest: Dr. Marty Makary, FDA Commissioner

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Episode Overview

This episode centers on a significant policy shift at the FDA regarding hormone replacement therapy (HRT) for menopausal women. The hosts, Georgia Howe and John Bickley, interview FDA Commissioner Dr. Marty Makary about the rationale behind lifting black box warnings on HRT, the science supporting these changes, benefits and risks of HRT, and broader FDA priorities—including updates to food guidance and accelerated drug approvals. The discussion aims to inform listeners about how new evidence is shaping women’s health strategies and broader public health initiatives.

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Key Discussion Points & Insights

1. FDA’s Update on Hormone Replacement Therapy (HRT)

Removal of Black Box Warnings:

• The FDA is eliminating black box warnings from estrogen products, which were originally added due to fears about cancer and other risks.
• Dr. Makary emphasizes that “the fear machine has been going on for 23 years,” and that the evidence does not support the degree of risk previously suggested.

  “Women who go through menopause and start hormone replacement therapy have profound short term and long term health benefits, including reducing the risk of bone fractures by 50 to 60% later in life, reducing the risk of fatal heart attacks by 30 to 50%. That’s the number one cause of death in women, and reducing cognitive decline.” – Dr. Makary (03:29)

Long-Term and Short-Term Benefits of HRT:

• HRT reduces the risks of bone fractures, fatal heart attacks, and cognitive decline when started within 10 years of menopause.
• Dr. Makary claims, “There may be no medication in the modern era, aside from perhaps antibiotics or vaccines, that can improve the health outcomes of women on a population level more than hormone replacement therapy started within 10 years of the onset of menopause.” (03:57)

Optimal Timing and Duration:

• HRT should be started around the time of menopause or within 10 years for maximum benefit.
• Many doctors prescribe HRT for life after initiation if begun within this window.
• After 10 years, the risk-benefit ratio may invert.

  “The key is it has to be started within years of the onset of menopause... when doctors started around the time of menopause or within 10 years, many do keep patients on it for life.” – Dr. Makary (04:25)

2. Eligibility and Safety Concerns

Relative and Absolute Contraindications:

• Absolute: Active breast cancer.
• Relative: Personal or strong family history of breast cancer, history of blood clots; alternatives like gel or vaginal forms exist for some riskiest groups.
• Historical studies overstated the risk of breast cancer; new evaluations show the increase was not statistically significant.
• Estrogen alone (for those without a uterus) may even have a protective effect.

  “The original study never had a statistically significant increase in the risk of breast cancer... In women who took estrogen alone... there was a protective effect.” – Dr. Makary (06:13)

3. Recognizing Menopausal Symptoms and Immediate Benefits

Underappreciated Severity:

• About 80% of women experience significant, often severe, menopausal symptoms lasting on average eight years.
• Symptoms include severe mood swings, night sweats, sleep difficulties, sexual pain, and weight gain.
• HRT (with estrogen or estrogen plus progesterone) often alleviates these symptoms.

  “Symptoms of menopause are massively underappreciated, under recognized and understudied... for many women, they are severe... These symptoms are often alleviated with estrogen.” – Dr. Makary (07:13)

4. New Medications for Menopausal Women

• The FDA is approving a generic estrogen/progesterone combination (generic Premarin) and a non-hormonal medication for those with contraindications to HRT.

  “One is a generic combination therapy of estrogen and progesterone... [the other] is a non-hormonal version for women who have a contraindication.” – Dr. Makary (08:08)

5. Broader FDA Initiatives in Health and Nutrition

Food Additive Bans, Nutritional Guidance Overhaul:

• The agency is pushing for removal of petroleum-based food dyes and updating infant formula guidance.
• A major overhaul of US dietary guidance (the “food pyramid”) is underway to combat outdated, industry-driven recommendations.
• Emphasis will shift to more protein, less processed/ refined carbohydrates, and debunking calorie-counting as the key to health.

  “We are rewriting that [food pyramid] guidance to make it now evidence based and not based on what the food industry tells you... We are ending a 50 year war on natural saturated fat... The idea that there was no dietary limit on sugar is an era we came out of.” – Dr. Makary (08:39)

6. FDA Leadership Priorities

Accelerating Treatments and Cures:

• Dr. Makary’s declared mission contrasts with predecessors:

  “My number one priority is not to censor Americans or fight misinformation. It’s to deliver more cures and meaningful treatments to the American public and healthier food for children. And we’re doing that.” (11:03)

• New pilot programs fast-track promising treatments—examples include gene therapy for childhood deafness and cancer drugs causing tumor remission without chemo/radiation.
• Focus areas: cures for type 1 diabetes, neurodegenerative diseases, PTSD, and truly transformative (not marginal) cancer treatments.

  “Sometimes they say no. But every now and then, we realize there’s a potentially promising treatment that we need to put at the front of the line.” (12:00)

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Notable Quotes & Memorable Moments

• “There may be no medication in the modern era... that can improve the health outcomes of women on a population level more than hormone replacement therapy started within 10 years of the onset of menopause.” – Dr. Makary (03:57)
• “The fear machine has been going on for 23 years.” – Dr. Makary (06:11)
• “Symptoms of menopause are massively underappreciated, under recognized and understudied...” – Dr. Makary (07:13)
• “We are rewriting... the food pyramid guidance to make it now evidence based and not based on what the food industry tells you.” – Dr. Makary (08:39)
• “My number one priority is not to censor Americans or fight misinformation. It’s to deliver more cures and meaningful treatments.” – Dr. Makary (11:05)

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Timestamps for Key Segments

• 03:17 – Dr. Makary joins the show
• 03:29 – FDA’s removal of black box warnings on HRT and rationale
• 04:21 – Ideal timing for initiating and duration of HRT
• 05:19 – Contraindications and cancer risk discussion
• 07:06 – Discussion of menopause symptoms and HRT benefits
• 08:01 – FDA greenlights new drugs for menopause
• 08:39 – Broader FDA initiatives: food additives and new dietary guidance
• 10:06 – Specific planned changes to the food pyramid
• 11:03 – Dr. Makary’s top priorities as FDA Commissioner
• 12:00 – Accelerating reviews for breakthrough treatments

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Tone and Language

Dr. Makary balances scientific detail with accessible language, aiming to clarify myths and fears around HRT and menopause while expressing urgency and optimism about FDA reforms. The hosts maintain a brisk, informative tone, pressing for clear explanations and practical implications for listeners.

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Summary Takeaway

This episode provides a deep dive into the shifting landscape of women’s medicine, with the FDA signaling a break from decades-old caution surrounding HRT in favor of evidence-based recommendations. Listeners receive not only an update on HRT and menopause, but insight into the FDA’s broader public health strategy—from overhauling outdated nutrition policy to expediting high-impact medical treatments.

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Transcript

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After decades of stagnation and caution, the FDA is radically changing their advice on hormone replacement therapy for menopausal women.

[E]

In this interview, we talk with FDA Commissioner Dr. Marty Makary about the new advice for women, as well as other shakeups happening in medicine at the highest level. I'm Georgia Howe with Daily Wire Executive Editor John Bickley and this is a weekend edition of Morning Wire.

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[E]

Joining us now to discuss the updated advice for women's health is FDA Commissioner Dr. Marty Makary. Dr. Makary, thanks for coming on.

[C]

Great to be with you.

[E]

So tell us about the announcement about HRT that your agency just put out this month.

[C]

Well, the FDA is removing the black box warnings that have scared women away from these estrogen products. Women who go through menopause and start hormone replacement therapy have profound short term and long term health benefits, including reducing the risk of bone fractures by 50 to 60% later in life, reducing the risk of fatal heart attacks by 30 to 50%. That's the number one cause of death in women, and reducing cognitive decline. So people think about hormone replacement therapy after menopause in terms of the short term benefits, but there are profound long term health benefits. In fact, there may be no medication in the modern era, aside from perhaps antibiotics or vaccines that can improve the health outcomes of women on a population level. More than hormone replacement therapy started within 10 years of the onset of menopause.

[E]

So do they stay on it for the duration of life? How does it actually work?

[C]

So many doctors do prescribe it for life after a woman starts it. The key is it has to be started within years of the onset of menopause because the body is naturally producing its own intrinsic estrogen, but that starts to decline and then go to zero around the time of menopause. So the replacement is replacing the body's estrogen that is known now to have some cognitive benefit and also to keep the blood vessels soft and dilated. It increases nitric oxide, which helps keep blood vessels dilated. And that's why There may be this profound cardiovascular benefit. Now, that risk benefit ratio inverts after about 10 years if hormone therapy is started more than 10 years after menopause. But when doctors started around the time of menopause or within 10 years of menopause, many doctors do keep patients on it for life.

[E]

Now, are there any women who are not good candidates? For example, I know for many years there was fear that it would increase cancer rates. So what about women who have say like the BRCA2 mutation?

[C]

So there are some contraindications that doctors have used. One of them is an active breast cancer. Other doctors have suggested that if there was a breast cancer in the past. Family history is a controversial area of contraindication. Someone who has a strong underlying risk of blood clots from a previous medical condition that predisposes them. These are some generally recognized contraindications. But many doctors are now saying, with the exception of active breast cancer, those are relative contraindications. And even women who are predisposed to blood clots can take a gel or vaginal form of the therapy. And you raise a good point that there is a fear machine that started 23 years ago, that hormone replacement therapy increases breast cancer mortality, that is, increases a woman's chances of dying of breast cancer. But in reality, that study was put out to the media before the results were put out in the medical literature. It never had a statistically significant increase in the risk of breast cancer in the original study. And women who took estrogen alone because they did not have a uterus and did not require the added progesterone, they had a much lower risk of breast cancer. There was a protective effect. So the fear machine has been going on for 23 years. The FDA piled on around that time and added these scary black box warnings. Today the FDA is taking action to remove these black box warnings so that women have the right information and are making the decision based on evidence, based on and not on the fear machine.

[E]

Now, for Gen X women who are maybe in the window where this is immediately useful to them, what sort of short term benefits are there?

[C]

So the symptoms of menopause are massively underappreciated, under recognized and understudied. I was told, for example, in medical school that some women have symptoms of menopause. They may last a couple years and they're usually mild. Well, that's not true. About 80% of women have significant symptoms of menopause. They last on average eight years. And for many women, they are severe mood swings, night sweats, difficulty sleeping, Pain with sexual activity, weight gain. And these symptoms are often alleviated with estrogen, that is with hormone replacement therapy, estrogen or estrogen plus progesterone. And so that message is under recognized and underappreciated both in the medical field and into the society at large.

[E]

Your agency also announced that it's green lighting two new drugs for menopausal women. What can you tell us about those new drugs?

[C]

So one is a generic combination therapy of estrogen and progesterone. It is a generic form of Premarin. And the other medication that we are advancing is a medication that can directly address some of these symptoms without a hormonal treatment. It's a non hormonal version for women who have a contraindication for estrogen or estrogen plus progesterone.

[E]

Now broadening out a bit. We like to keep tabs on all things Maha on this show. So what are the top initiatives being pushed right now and what kind of progress have we seen?

[C]

So we've done a lot in calling on the industry to remove all nine petroleum based food dyes in the next tier of chemicals. We are revising infant formula guidance and we are now working on changing the food pyramid. That is the broken dietary guidance that has come out of the government that has done tremendous damage in school lunch programs, in military bases and everywhere that food is served. We are rewriting that guidance to make it now evidence based and not based on what the food industry tells you they want you to buy. We are ending a 50 year war on natural saturated fat. We're talking about the types of grains, the importance of fiber and the importance of food that comes out of good soil. And we want to let people know that refined carbohydrates do have an effect on the body and drive up insulin levels to heights that we've never seen before in human history. And this is something that people should track and keep tabs on because the idea that there was no dietary limit on sugar is an era that we came out of. And so this is the first generation to see insulin and sugar spikes at levels that have not been seen before in human history.

[E]

Now, drilling down a little bit on the food pyramid or whatever infographic you plan to use, what specific changes are you making to those recommendations?

[C]

Well, I think there's been a false dogma that the calories in calories out count has been a zero sum game. And it was just that simple. And it didn't matter if you had bad food that was highly processed. It was just a matter of, of how much time you spent running or on a treadmill. And so that concept is a broken concept. And we're rewriting now the guidance to talk about the value of protein. For example, there's a recognition now that maybe we need more protein than has been recommended in the past. Our doctors are still meeting. We're actively working with usda, and we're gonna be putting out this guidance in the coming months. And I think people are really gonna see a refreshing new framework for thinking about the food that they eat and where it comes from.

[E]

Now, I'm gonna save my questions about statins and cholesterol for next time you're on. But in terms of your post, what are your top priorities as commissioner of the FDA right now?

[C]

So my predecessor in the Biden administration at the FDA said that his number one priority was to fight misinformation. Well, my number one priority is not to censor Americans or fight misinformation. It's to deliver more cures and meaningful treatments to the American public and healthier food for children. And we're doing that. We are going into the pipeline of new cures that are potentially promising, under review at the fda. I personally go to the scientists on the front lines at the FDA and ask them, are you seeing anything that looks amazing? Are you seeing anything in animal studies? A new mechanism of action? Something in an early phase two trial that could be a game changer? Is there anything you're seeing that gives you chills up your spine? And sometimes they say no. But every now and then we realize there's a potentially promising treatment that we need to put at the front of the line. And so we're doing that now with a new pilot program to get decisions out in weeks instead of a year. And we're proactive. We're not just in receive only mode. I wanna see a powerful treatment or cure for type 1 diabetes in our term for neurodegenerative diseases, a treatment for those suffering with ptsd. We wanna see treatments for cancer that are a leap forward, not an added survival benefit of two weeks. We discovered, for example, a article in the New England Journal of Medicine a few weeks ago that showed a gene therapy for a form of childhood deafness restored hearing in three out of 12 kids who got it. And other kids had some benefit as well. Well, within hours of that article being public, we then went into the pipeline and moved that application to the front of the line, called the company, and that's going to get a priority review within weeks. We're doing the same with cancer treatments that can melt away a cancer without any chemo or radiation or surgery. That is game changing. And so we have prioritized drugs that are in our national priority interests, increasing affordability, moving manufacturing to the United States and meeting an unmet health need. And so we're doing that and we're gonna keep going.

[E]

All right. Well, Dr. Makary, thank you so much for coming on.

[C]

Good to be with you, Georgia.

[E]

That was FDA Commissioner Dr. Marty Makary. And this has been a weekend edition of MORNING wire.

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