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.
Nov 21, 2019 14
“Approved” “Hormone Therapy” For Women is Mostly Not Bio-Identical, is “One-Size-Fits-All,” and Not Safe for Use
The following article is by Dr. Jonathan V. Wright. The original article appears in the November 2019 issue of the Green Medicine Newsletter. Action Alert! The September 24th issue of the Journal of the American Medical Association (“JAMA”) reprinted an article originally published in The...
Nov 7, 2019 276
An update in the fight to protect estriol and other hormones from an FDA ban. Action Alert! We’ve said before that the FDA is stacking the deck against bioidentical hormones; now it seems incontrovertible. Time is running out for the natural health community to mount an effective defense o...
Nov 7, 2019 1
[embed]https://youtu.be/cZkNRCDQ7BI[/embed] This week's stories: Rigged Process Glyphosate In Kid's Cereal Join ANH In Our Fight [wpforms id="74677" title="false" description="false"]...
Oct 20, 2019 86
Help us defend bioidentical hormone replacement therapy from an FDA ban. Action Alert! We at ANH-USA have been keeping a close watch over the FDA’s ongoing process to regulate customized, natural medicines made at compounding pharmacies. Time and time again throughout this process, we’ve seen...
Oct 7, 2019 75
It may come to that if a key policy isn’t changed. Action Alert! As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA issued a revision of a bad policy that will limit the amount of medicines compounding pharmacies can send out of state. The revision offers some...
Apr 10, 2019 0
Legislation has been introduced to protect patient access to customized natural medicines. It needs our support. Action Alert! Representative Morgan Griffith (R-VA) has reintroduced a bill to ensure continued consumer access to customized natural medicines made at specialized pharmacies (know...
Mar 14, 2019 8
Hormones are safe from one threat, but the danger isn’t over. Action Alert! In 2016, we detailed a new threat to bioidentical hormones, which help with hormonal imbalances, such as menopause or fertility challenges. TherapeuticsMD (TMD), a drug company specializing in women’s heal...
Nov 1, 2018 1
Thanks to your activism, the FDA has agreed to study bioidentical hormone replacement therapy. But the threat to hormones still looms. Action Alert! For months now, we’ve been telling you about the FDA’s attack on estriol, progesterone, and other bioidentical hormones that are made for ind...
Sep 27, 2018 1
The FDA has dialed back a restrictive policy that would severely limit access to individualized natural medicines—but it’s not good enough. Action Alert! The FDA has released a revised draft policy relating to customized, natural medicines made at compounding pharmacies. This revised policy d...
Jul 10, 2018 0
If the FDA is not dissuaded, millions of women will lose access to life-saving hormones that are often safer than the alternatives currently on the market. Want more information or to find out how you can help? Contact Jo Twombly at [email protected] or 240-345-1510. How is Access to Bioidentica...