Dr. James Simon Speaks at FDA Panel: Advocating for Women’s Health and Accurate Labeling of Low-Dose Vaginal Estrogen Products
At a recent FDA panel, nationally recognized women’s health expert Dr. James Simon of IntimMedicine Specialists delivered a compelling statement on the importance of updating warning labels on low-dose vaginal estrogen products. Dr. Simon addressed the panel with clarity and urgency, spotlighting inconsistencies between current FDA labeling practices and the scientific data.
“The FDA faces a difficult balancing act in constructing understandable and accurate labels,” Dr. Simon acknowledged. “But in terms of low-dose vaginal estrogen, I believe they have failed.”
The Problem with Current FDA Labels
Since the 2002 Women’s Health Initiative and the resulting class labeling changes, all estrogen products have been required to carry warnings about potential risks such as stroke, dementia, heart attack, breast cancer, deep vein thrombosis (DVT), and endometrial cancer. Dr. Simon challenged the relevance of these warnings for low-dose vaginal estrogen, explaining that these products do not significantly raise estrogen levels in the bloodstream.
“You cannot measure [the estrogen] in the blood,” Dr. Simon emphasized. “So you cannot interpret the delivery of low-dose vaginal estrogens as causing all these things that are horrible and painful, that keep patients from using the products when they need them.”
The Call for Consistency and Scientific Integrity
Dr. Simon underscored two core principles of good labeling:
- Labels should be based not only on clinical trial data but also reflect the broader scientific literature.
- Labels should be consistent across products used for the same treatment.
Using FDA-approved products Invexi and Intrarosa as examples, he pointed out that while both products deliver comparable blood levels of estrogen, they are labeled very differently. Intrarosa, notably, does not carry warnings about heart attack, stroke, or dementia, despite having the same systemic exposure as Invexi.
“That’s not for the regulators to decide differently. That’s for the marketplace to sort out,” he said. “The label needs to be changed for low-dose hormone therapy. It’s not consistent, and it’s not in any way logical, reasonable, or aligned with the scientific literature.”
What the Research Shows
Dr. Simon also referenced large-scale observational studies, 400,000 U.S. patients and 200,000 patients in Denmark, that showed no increased risk to the endometrium, the organ most likely to be affected by vaginal estrogen placement.
These findings directly contradict the fear-inducing labels that may discourage patients from seeking effective treatment for genitourinary syndrome of menopause (GSM) and other conditions.
Hear Directly from Dr. Simon
In the video above, Dr. Simon breaks down the science, challenges the current labeling of low-dose vaginal estrogen, and advocates for evidence-based change.
You can also watch the entire FDA panel discussion to hear perspectives from additional experts in the field.
If you’re seeking guidance on hormone replacement therapy or navigating symptoms of menopause, schedule a consultation with Dr. Simon today. Having a doctor who not only understands the science but also advocates for your health at the national level makes all the difference.
Schedule your appointment by calling (202) 293-1000 or contact us here!
