What Really Happened at the FDA Menopause Panel

The FDA finally held a hearing on menopause—and it was long overdue. Georgie Kovacs breaks down the powerful expert testimony, the systemic failures, and why this matters for every woman navigating midlife care.

In this grounded recap, you’ll learn:

• Why the FDA’s black box warning on vaginal estrogen may be misleading

• The difference between systemic and local hormone absorption—and why it matters

• How testosterone access for women remains limited despite clear clinical need

• What experts like Dr. James Simon, Dr. Heather Hirsch, and Dr. Rachel Rubin said that might change the game

• One big thing missing: progesterone. Should women with a uterus be taking it?

“Can we fix menopause care if doctors aren’t trained, patients are afraid, and the FDA mislabels essential treatments?” -Georgie Kovacs
What Really Happened at the FDA Menopause Panel

FDA's Landmark Menopause Hearing: Key Takeaways and Unanswered Questions

On July 17, the FDA held a pivotal and long-overdue public hearing on menopause, signaling a potential shift in how women’s midlife health is addressed in the United States. This event, largely catalyzed by the advocacy group Let’s Talk Menopause under the #unboxingmenopause campaign, brought together top experts to tackle misconceptions and call for improvements in care and education for millions of women.

Why the Hearing Was Needed

At the center of the push for this hearing was the issue of a black box warning on vaginal estrogen products. Vaginal estrogen, essential for managing symptoms like vaginal dryness, recurrent urinary tract infections (UTIs), and painful sex, is often avoided by both patients and physicians due to the FDA’s strict warning label. Many experts argue that this warning is not supported by current evidence, leading to unnecessary fear, under-prescription, and underuse.

The Backdrop: The Shadow of the WHI Study

Much of today’s cautious approach to hormone therapy is rooted in the 2002 Women’s Health Initiative (WHI) study. The initial results of this large clinical trial suggested a significant increase in risks for stroke, breast cancer, and cardiovascular disease among women using hormone therapy. However, as several experts during the hearing pointed out, the study’s design and its population (mainly older women, not those freshly in menopause) have led to decades of confusion and fear. Many now believe the WHI’s findings were overgeneralized, creating lasting trauma for both doctors and patients and contributing to widespread undertreatment.

The Impact on Medical Training and Patient Care

The negative fallout from the WHI era extended into medical education, with reduced training hours leading to cuts in menopause-related instruction for residents. The result: entire generations of healthcare providers have limited knowledge in this area, amplifying barriers to effective care.

Fortunately, organizations such as the Menopause Society are investing substantial resources—bolstered by a recent $5 million grant—to reverse the trend and improve clinician education.

Key Insights from Expert Testimony

Hormone Therapy Misconceptions: Experts emphasized the importance of separating fact from myth. In particular, vaginal estrogen is not systemically absorbed, meaning its effects are localized and it does not carry the same risks addressed by the black box warning. There is substantial data—including studies involving hundreds of thousands of women—showing negligible systemic absorption and minimal associated risks.

Testosterone for Women: The absence of an FDA-approved testosterone product for women in the U.S. was another major issue. Physicians are forced to prescribe off-label, facing regulatory hurdles that their male-focused counterparts do not. Internationally, approved options exist, but progress in the U.S. is slow.

Osteoporosis and Hormone Therapy: One in two women over 50 will suffer an osteoporotic fracture, yet very few are using hormone therapy to prevent it, despite clear potential benefits.

Need for Broader Care Teams: The panel underscored that menopause care should not fall solely to OB/GYNs. Internal medicine and other healthcare professionals have vital roles to play.

Stories from the Panelists

Deeply personal and moving stories brought home the consequences of current policies. One physician described patients so frightened by the black box label that they flushed their prescriptions down the toilet. Another told of women suffering fractures or critical illnesses that hormone therapy or vaginal estrogen could have helped prevent—stories illustrating the real human cost of information gaps and regulatory inertia.

Missing Pieces: Progesterone and Individualization

While estrogen and testosterone received center stage, progesterone was a glaring omission. This hormone is vital for women with a uterus to protect against uterine cancer when using estrogen therapy, but important questions remain about which formulation—progesterone versus progestin—should be preferred. The discussion also touched on hormonal IUDs and dose equivalencies, hinting at a need for much more nuanced guidance.

A Systemic Challenge: The Healthcare Ecosystem

The hearing highlighted the complex web of players shaping women’s health:

Researchers must ensure studies reflect women’s real experiences.

Clinical trials need to include representative female populations.

Regulators must use accurate, condition-specific data for approvals.

Payers should reimburse effective treatments, using appropriate diagnostic codes.

Clinicians need better education and more tools.

Patients and the media must advocate for clear, comprehensive understanding.

Improvement will depend not on blaming a single party, but on each of these groups rising to the challenge.

Final Thoughts

The FDA hearing marks a critical step toward correcting decades of misconceptions and neglect in menopause care. The facts are clear: menopause is not a disease, but a life stage, and women deserve informed, individualized care. As the conversation grows—in the media, online, and in clinics—the hope is for a future where policy, research, and everyday practice empower those in midlife and beyond.

Always discuss medical decisions with your healthcare provider—this article is for informational purposes only.

 

Thread 'FDA Expert Panel on Menopause and HRT Recommends Removing Black Box Labels'

Jul 17, 2025

This was a very important meeting with top experts that are trying to change guidelines. This FDA panel recently recommended removing the warning (“black box”) labels on menopausal HRT, citing potential benefits like reduced heart attack and bone fracture risk—and arguing the warning discourages appropriate use.

FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women​

Hopefully, we will see progress in this field after the confusing and sometimes misleading conclusions of the WHI (“Women’s Health Initiative”), a large National Institutes of Health trial...

• madman
• menopause; hrt; estrogen; testosterone; health
• Replies: 5
• Forum: HRT in Women

 

Briefing Document: The FDA Menopause Panel and the Fight for Accurate Women's Health Information​

Source: Excerpts from "What Really Happened at the FDA Menopause Panel - Fempower Health | A Women's Health Podcast" by Georgie Kovac.

Date of FDA Hearing: July 17th (Year not specified, but context suggests recent)

Prepared by: [Your Name/Department]

I. Executive Summary​

This briefing document summarizes key takeaways from a recent FDA hearing on menopause, initiated by the "Let's Talk Menopause" campaign (#unboxingmenopause). The hearing primarily addressed the mislabeling of vaginal estrogen with a "blackbox warning," which has led to widespread fear and under-prescription of this vital treatment. Experts at the hearing highlighted the enduring negative impact of the 2002 Women's Health Initiative (WHI) study, which erroneously linked hormone therapy to severe health risks based on flawed data. The discussion extended to the benefits and regulatory challenges of testosterone for women, the underutilization of hormone therapy for osteoporosis prevention, and the critical need for improved medical education and a holistic approach to women's health. A key point of contention was the lack of discussion around progesterone and the need for a comprehensive healthcare ecosystem that includes researchers, regulatory bodies, payers, clinicians, and media working in concert.

II. Main Themes and Key Insights​

A. The Misinformation Crisis in Menopause Care: A Legacy of the WHI Study​

• The 2002 WHI Study's Devastating Impact: The hearing revealed the lasting "PTSD" experienced by medical professionals due to the 2002 Women's Health Initiative (WHI) study. This study, originally intended for cardiovascular disease research, "shared that if women are on hormone therapy they will get stroke breast cancer vascular disease and many other factors." This conclusion was flawed because "the results came out but they were really for older patients so they didn't really give us the right information for people who are actually in premenopause." The study's misinterpretation led to widespread fear, causing patients to "throw their hormones in the garbage" and doctors to stop prescribing hormone therapy.
• Consequences for Medical Education: The WHI study's impact coincided with a reduction in medical school training hours for residents, leading to "menopause training was cut." This has resulted in a significant lack of education among physicians regarding menopause care, a problem the Menopause Society is now trying to address with grants and educational initiatives.
• The Blackbox Warning on Vaginal Estrogen: A central focus of the hearing was the "blackbox warning," the "strictest label that the FDA can put on a given product," applied to vaginal estrogen. Experts believe this label is "wrong" and "scaring both physicians from prescribing it to patients as well as patients from taking it."
• Vaginal Estrogen's Localized Action: Dr. Simon emphasized that vaginal estrogen is "not systemically absorbed." He pointed out that "even if you did blood work like you couldn't measure the estrogen because it is not absorbed in the blood." Data from "400,000 women in the US and 100,000 in the EU" shows it "doesn't even they don't even see it in the endometrium," challenging the idea that it could cause systemic issues like breast cancer or cardiovascular disease.
• Real-World Consequences of Misinformation: Tragic stories were shared, such as cancer patients whose family members, upon seeing the package insert with the blackbox warning, would "throw it away and said 'It's not worth us having sex for you to possibly get cancer again.'" Dr. Rachel Rubin shared a personal story of her mother in the ICU due to recurrent UTIs, highlighting the "unbelievable" hurdles faced even by a doctor trying to obtain necessary vaginal estrogen.
• Benefits and Safety: Vaginal estrogen is highlighted as safe and highly beneficial for "genital urinary syndrome of menopause," preventing "recurrent UTI, helps with vaginal dryness, pain with sex and so many other factors." The consensus among presenting physicians is that "vaginal estrogen is safe."

B. Untapped Potential and Regulatory Hurdles for Other Hormone Therapies​

• Testosterone for Women: Dr. Kelly Casperson discussed the "lot of benefits for testosterone," with some patients even getting "off anti-depressants once they're on testosterone." However, a significant barrier is that "there is not an FDA approved one in the United States for women," unlike in other countries. Doctors are forced to prescribe it "off label," and companies trying to gain FDA approval face a continuous demand for "more data."
• Osteoporosis Prevention: Dr. Rhonda Wright, an orthopedic surgeon, coined the term "musculoskeletal syndrome of menopause." She starkly stated that "one in two women over 50 will suffer an osteoporotic fracture and yet fewer than 5% are using hormone therapy to prevent it." She emphasized, "we're putting rods in the hips of women for fractures that estrogen could have prevented."

C. Gaps in the Discussion and the Need for a Holistic Ecosystem​

• The Missing Progesterone Discussion: A significant point of regret from the podcast host was the lack of discussion regarding progesterone, particularly the distinction between "progesterine versus progesterone." The host noted that "even though the breast cancer risk was you know not a significant one there was a difference in the arm that took progesterone versus progestine and not a lot of people are talking about this." This lack of clarity extends to appropriate dosing and interactions with other hormonal birth control methods.
• Beyond OB/GYNs: The hearing highlighted that "we can't rely on just the OBGYN" for menopause care. Internal medicine physicians and others "can really really support women in this stage of life."
• The Interconnected Healthcare System: The podcast emphasized that effective women's healthcare requires a collaborative effort from all stakeholders:
• Researchers: To study how diseases "show up in women alone or differently or disproportionately."
• Clinical Trials: To "include women not just as afterthoughts but as part of the process."
• Regulatory Bodies (FDA): To "understand these conditions deeply so that when the drug approvals come they're approving it from the right perspective."
• Payers: To "reimburse the treatments that work," supported by "proper ICD9 codes."
• Clinicians: To be "trained not just improvising because they have a small toolbox to play with."
• Patients: To "advocate for themselves."
• Media: To "go beyond the headlines and does the hard work of explaining the full picture." This collaborative approach is the "formula" and "it is not about blaming any one player."

III. Key Quotes​

• "The concern by the experts is that this label is wrong and because of it it is scaring both physicians from prescribing it to patients as well as patients from taking it."
• "Many of the experts really painted a picture of the PTSD they still experienced because of what happened in July [2002]."
• "The original study [WHI] was intended to better understand cardiovascular disease but... the results came out but they were really for older patients so they didn't really give us the right information for people who are actually in premenopause."
• "Dr barbara Levy is actually one who had shared that she still has PTSD from 2002 and it's really sad because she iterated that patients were calling and they were throwing their um their hormones in the garbage."
• "Medical schools... were also decreasing the number of hours that they um had for residents to go in... clearly menopause training was cut and so now we're recovering from that."
• "There is not an FDA approved [testosterone] in the United States for women however in other countries there are approved doses so what's happening is now the doctors are having to prescribe it off label."
• "One in two women over 50 will suffer an osteoporotic fracture and yet fewer than 5% are using hormone therapy to prevent it... we're putting rods in the hips of women for fractures that estrogen could have prevented." - Dr. Rhonda Wright
• "Vaginal estrogen is not systemically absorbed... even if you did blood work like you couldn't measure the estrogen because it is not absorbed in the blood." - Dr. Simon
• "The family member would see the package insert and... would have all the warnings and then the loved one would see it they would throw it away and said 'It's not worth us having sex for you to possibly get cancer again.'"
• "If you're treating all estrogen alike this is a problem because now women who need something that could really really help them and save their lives aren't getting the product that they need because it's mislabeled."
• "Her mom could have died and she really needed um the vaginal estrogen to help her with one of the things um that brought her into the ICU." - Dr. Rachel Rubin
• "Generally the consensus amongst all the physicians that were presenting is vaginal estrogen is safe."
• "The question that I have had all along is progesterine versus progesterone... not a lot of people are talking about this."
• "It is not about blaming any one player it is all these players need to do the right thing for the health care system to work and especially for women."

IV. Recommendations/Next Steps (Implied from the Source)​

1. FDA Action on Blackbox Warning: Review and remove the blackbox warning on vaginal estrogen to accurately reflect its safety profile and ensure access for patients.
2. Expedite Testosterone Approval for Women: Prioritize FDA approval processes for testosterone for women, providing clear guidelines and support for necessary research.
3. Enhance Medical Education: Support initiatives like those by the Menopause Society to improve menopause training for all medical professionals, not just OB/GYNs.
4. Promote Comprehensive Hormone Therapy Awareness: Educate both physicians and the public on the benefits of hormone therapy for conditions like osteoporosis and the accurate distinction between different hormone formulations (e.g., systemic vs. vaginal estrogen, progesterone vs. progestin).
5. Facilitate Interdisciplinary Collaboration: Foster better communication and collaboration among researchers, regulatory bodies, pharmaceutical companies, payers, clinicians, and media to build a more effective and equitable women's healthcare system.
6. Address Progesterone Clarity: Future FDA hearings or dedicated discussions should provide clear guidance on progesterone formulations, dosing, and its role in hormone therapy.

 

1. Why was the recent FDA hearing on menopause held, and what was its primary focus?​

The FDA held a long-overdue hearing on menopause due to a campaign by "Let's Talk Menopause" under the hashtag #unboxingmenopause. The primary focus was to address the black box warning on vaginal estrogen products. Experts contend that this is the strictest label the FDA can apply and is misleading, causing fear among both physicians in prescribing it and patients in taking it, even leading some to discard prescriptions. The hearing aimed to correct this misinformation surrounding hormone therapy in general.

2. How did the 2002 Women's Health Initiative (WHI) study impact the perception and prescription of hormone therapy?​

The 2002 Women's Health Initiative (WHI) study's reports incorrectly suggested that women on hormone therapy would develop stroke, breast cancer, and vascular disease. This led to widespread fear, with patients discarding their hormones and doctors ceasing prescriptions. The study's flaws included enrolling older patients (who tend to have more cardiovascular disease) rather than the younger perimenopausal demographic, and a misassessment of risk factors. The negative fallout from this study was so severe that some experts at the hearing described experiencing "PTSD" from it, contributing to a significant decline in menopause training in medical schools and a general lack of education among healthcare providers.

3. What are the key concerns surrounding the black box warning on vaginal estrogen, and why is it considered problematic?​

The black box warning on vaginal estrogen is considered problematic because, unlike other forms of estrogen, vaginal estrogen is not systemically absorbed. Experts at the hearing highlighted that it cannot even be measured in the blood and has no detectable impact on the uterine lining, which would be the first area of systemic effect. Therefore, associating it with systemic risks like cardiovascular disease or breast cancer, as implied by the black box warning, is scientifically inaccurate. This mislabeling prevents women, including cancer patients, from accessing a safe and effective treatment for symptoms like vaginal dryness, recurrent UTIs, and painful sex, which are components of genitourinary syndrome of menopause (GSM).

4. What challenges do women face in accessing FDA-approved testosterone therapy, and why is this an important discussion?​

A significant challenge is that there is no FDA-approved testosterone for women in the United States, despite approved doses existing in other countries. This forces doctors to prescribe it off-label, leading to issues with insurance coverage and clarity on appropriate microdosing. The discussion around testosterone for women is crucial because it offers potential benefits, including helping some patients get off antidepressants. The contrast was drawn with male testosterone studies, which are approved much faster, highlighting a systemic barrier in approving women-specific treatments.

5. Beyond estrogen and testosterone, what important hormone was notably absent from the FDA hearing discussions, and why is its clarity important?​

Progesterone was notably absent from the FDA hearing discussions, despite its importance, especially for women with a uterus to prevent uterine or endometrial cancer when taking hormone therapy. The presenter expressed a personal desire for more clarity regarding progesterone versus progestin (synthetic progesterone), given that the WHI study showed a difference in breast cancer risk between arms taking these two forms. There's also confusion surrounding appropriate dosing, especially for women using hormonal IUDs or birth control pills during perimenopause. Clear guidelines and further discussion on progesterone are needed to ensure comprehensive and safe hormone therapy.

6. How has the lack of proper training in medical schools impacted menopause care, and what efforts are being made to address this?​

The WHI study's impact led to a significant reduction in menopause training hours in medical schools, as cuts were made to accommodate decreased residency hours. This resulted in a generation of physicians lacking adequate knowledge and tools to provide proper menopause care, leading to a "small toolbox" approach. To address this, organizations like the Menopause Society are actively working on educational initiatives, including securing grants to fund training. There's also a growing recognition that menopause care shouldn't solely fall to OB/GYNs, and other physicians, like internal medicine doctors, need to be equipped to support women in this life stage.

7. What is "genitourinary syndrome of menopause" (GSM), and how can vaginal estrogen or other therapies help?​

Genitourinary syndrome of menopause (GSM) is a collection of symptoms caused by hormone changes during menopause, including vaginal dryness, recurrent urinary tract infections (UTIs), and pain with sex. Vaginal estrogen is highly effective in treating GSM because it is not systemically absorbed and directly addresses these localized symptoms. New guidelines have been created for GSM that outline its management, including addressing concerns about breast cancer risk. Other options like DHEA are also available, emphasizing that localized therapies can provide significant relief and prevent serious health issues like recurrent UTIs leading to hospitalization.

8. What is the comprehensive "formula" for a well-functioning healthcare system, particularly in the context of women's health?​

A well-functioning healthcare system, especially for women's health, requires a collaborative effort from multiple stakeholders, rather than blaming any single entity. The "formula" includes:

• Researchers who study diseases and conditions that show up in women alone, differently, or disproportionately.
• Clinical trials that intentionally include women, not as afterthoughts.
• Regulatory bodies (like the FDA) that deeply understand these conditions for accurate drug approvals and labeling.
• Payers who reimburse for effective treatments, requiring proper ICD9 codes.
• Clinicians who are well-trained and equipped with the right tools.
• Patients who are empowered to advocate for themselves.
• Media that provides full, accurate explanations beyond sensational headlines.

This holistic approach is crucial for ensuring that the healthcare system adequately serves women's unique health needs throughout their life stages, like menopause.