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.