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

Episode Date: November 22, 2025

After decades of stagnation and caution, the FDA is radically changing their advice on hormone replacement therapy for menopausal women. We speak to the FDA Commissioner about the new advice for women. Get the facts first with Morning Wire. Chevron: Build a brighter future right here at home. Visit https://Chevron.com/America to discover more. HelloFresh: Go to https://HelloFresh.com/MORNINGWIRE10FM now to Get 10 Free Meals + a Free Item for Life! - - - Wake up with new Morning Wire merch: https://bit.ly/4lIubt3 - - -Privacy Policy: https://www.dailywire.com/privacy Learn more about your ad choices. Visit podcastchoices.com/adchoices

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All access members get early access to episodes one and two at Christmas Day. 50% off Black Friday is our biggest sale of the year. It only happens once a year. When it's gone, it's gone. Go to DailyWire.com slash subscribe and join now. After decades of stagnation and caution, the FDA is radically changing their advice on hormone replacement therapy for menopausal women. In this interview, we talk with FDA Commissioner Dr. Marty McCarrie 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. America is built on hard work and powered by American energy. Chevron has spent

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One per box with active subscription, free meals applied as discounts on first box, new subscribers only, varies by plan. That's Hellofresh.com slash MorningWire 10 FM to get 10 free meals plus free breakfast for life. Joining us now to discuss the updated advice for women's health is FDA Commissioner Dr. Marty McCarrie. Dr. McCarrie, thanks for coming on. Great to be with you. So tell us about the announcement about HRT that your agency just put out this month. 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 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.

So do they stay on it for the duration of life? How does it actually work? So many doctors do prescribe it for life after a woman starts. 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. 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 Bracca 2 mutation? So there are some contradications 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've

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 and not on the fear machine. 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? 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. Your agency also announced that it's greenlighting two new drugs for menopausal women. What can you tell us about those new drugs? So one is a generic combination therapy of estrogen and progesterone. It is a generic form of premarine. And the other medication that we're 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. 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? 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. 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? 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 how much time you spent running or on a treadmill. And so that concept is a broken concept. And 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 that has been recommended in the past. Our doctors are still meeting.

We're actively working with USDA. And we're going to be putting out this guidance in the coming months. And I think people are really going to see a refreshing new framework for thinking about the food that they eat and where it comes from. Now, I'm going to 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? 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 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 want to see a powerful

treatment or cure for type 1 diabetes in our term for neurodegenerative diseases, a treatment for those suffering with PTSD. We want to 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 week. 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 going to keep going. All right. Well, Dr. McCarrie, thank you so much for coming on.

Good to be with you, Georgia. That was FDA Commissioner, Dr. Marty McCarrie, and this has been a weekend edition of Morning Wire.