Estriol and other compounded bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List; items that appear on the list when it is final will no longer be able to be made at compounding pharmacies.
Estriol is particularly at risk. Since there is no FDA-approved estriol drug, consumers would completely lose access to this critical hormone if the FDA goes through with a ban. Many integrative doctors prefer compounded bioidentical hormones to synthetic or animal-derived hormones for their superior safety profile and the ability to tailor medicines to a patient’s individual needs.
Estriol’s nomination is especially concerning given the FDA’s demonstrated hostility toward this hormone. In 2008, the agency ruled that pharmacies could not compound medicines containing estriol without first obtaining an investigational new drug application.
As the FDA goes through its process, it has become clear that the agency is stacking the deck against estriol and other compounded hormones. Presentations to FDA advisory committees have been heavily biased against compounded hormones; advocates in favor of and with an expertise in bioidentical hormones have been given a comparatively limited time to present their case.
ANH is fighting for the 2.5 million women who rely on compounded bioidentical hormones to stay healthy.
- When the FDA tried to stop compounders from making compounded bioidentical estriol medicines in 2008, we spearheaded a successful grassroots campaign to push back and retain consumer access to estriol.
- Submitted petition to an FDA advisory committee evaluating the clinical utility of compounded BHRT to request more time for BHRT experts to present.
- Helped encourage the removal of PEW as a voting member of the Pharmacy Compounding Advisory Committee.
Jun 21, 2018 6
Help us get Congress to step in and tell the agency to knock it off. Action Alert! What if we were to tell you that there was a treatment for the effects of menopause that: Didn’t come with the dangers of the alternatives, such as increased risk of endometrial cancer and heart disease; ...
May 24, 2018 0
ANH members played a key role in thwarting efforts to eliminate access to personalized medicine. Two years ago, the FDA released a draft guidance saying that a compounding pharmacy (a pharmacy that makes customized medicines for individual patients) cannot register as both an “outsourcing” (5...
Jan 4, 2018 5
The FDA may eliminate consumer access to estriol and other hormones. We must stop them. Action Alert! As we’ve detailed previously, the FDA is waging a War on Women’s Health and is even moving to ban compounded bioidentical estriol, which millions of women use to feel better and protect thems...
Dec 18, 2017 12
Many millions of women depend on it. Action Alert! In 2008, the FDA – likely acting upon a petition it received from Wyeth Pharmaceuticals, the manufacturer of Premarin (an estrogen drug made from pregnant horse mares’ urine) – went after bioidentical hormones, particularly estriol. Thanks ...
Oct 30, 2013 19
Could it be because the author of the CDC-funded study has ties to the pharmaceutical industry? (more…)...
Oct 26, 2010 34
Nurses in Oregon may soon lose their ability to prescribe estriol, the safe and effective bioidentical estrogen hormone. Meanwhile, an FDA-approved menopause drug is killing women at twice the usual mortality rate. (more…)...
Sep 9, 2008 1
AAHF and its project HOMECoalition.org are joining the International Academy of Compounding Pharmacists and other groups in a nationwide call-in campaign to protect our access to estriol and bio-identical hormone replacement therapy (BHRT). WE NEED YOUR SUPPORT. The BHRT National Congressional ...
May 12, 2008 3
Quick Update: If you haven’t taken action yet, please do so now! We have also heard that the Wyeth is already gearing up to fight this tooth and nail. We have also learned that Wyeth is coordinating women’s groups to write letters in opposition of the resolution. We need you to help spr...