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

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.

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)

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)

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

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.

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.