An update on our efforts to protect consumer access to compounded bioidentical hormones, including estriol. Action Alert!
As regular readers will be aware, the FDA is poised to eliminate consumer access to compounded bioidentical hormones like estriol, progesterone, testosterone, and others. We’re working with our allies to mobilize members of Congress to take action on this critical women’s health issue. We need your help to get as many members to support our cause as we possibly can.
Representatives Mark Pocan (D-WI) and Phil Roe (R-TN) are leading a Congressional letter asking the FDA to “consider the severely negative impact some of [the National Academies of Sciences, Engineering, and Medicine’s] recommendations would have on patients,” and requesting that consumer access to compounded bioidentical hormones be maintained.
To briefly recap how we got here: estriol and other hormones were nominated to the FDA’s Demonstrably Difficult to Compound List. Items that appear on the final list will be barred from pharmacy compounding. This was particularly concerning given that the FDA had previously attacked estriol in 2008, but was beaten back on account of ANH member activism. After initial pushback from the natural health community against the latest attack, the agency asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to impartially evaluate the “clinical utility” of using compounded bioidentical hormones to treat patients. NASEM’s evaluation report, which was heavily slanted against compounded bioidentical hormones, was released in late July of this year (read our analysis here).
Suffice it to say, in our view, the FDA carefully managed this process to achieve an intended result: eliminating access to compounded bioidentical hormones to create a monopoly for FDA-approved hormones. With an “impartial” report from the “experts” at NASEM, the FDA has given itself cover to ban compounded BHRT.
This is a critical issue, particularly for women. Many studies have shown that estriol offers many potential health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer. A ban would cause suffering for many, many women. But as we’ve written before, this is one among many attacks that, in our opinion, is meant to make it impossible for traditional compounding pharmacies to stay in business.
The FDA still needs to go through the normal rulemaking process before estriol or other hormones are banned from compounding, but the time to act is now. We must get Congress on our side to try to reign in this agency.
Attacking estriol and compounded hormones to clear the market for FDA-approved hormone drugs is just one of the ways the FDA and the federal government bolster drug monopolies and undermine natural health options. Our crony healthcare system bars not only the use, but even the mention, of natural remedies like vitamin D that have not been, and never can be, put through the multi-billion dollar FDA approval process, because as natural substances they cannot be fully patented. Until this system changes, we will remain a nation of sick people paying way too much for healthcare that is ineffective.
Action Alert! Write to Congress and urge your elected officials to support the letter asking the FDA to protect consumer access to compounded bioidentical hormones. Please send your message immediately. By sending this message, you will also be supporting our petition to ungag doctors so that they can share with patients the benefits of supplements and natural treatments for COVID.
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This is to ask you to please protect consumers rights for compounded bio identical hormones. As a practitioner specializing in bio identical hormones for 24 years, I have seen enormous benefits from these hormones for women. They change their lives dramatically for the best and I myself use them and can’t imagine not having access to them. It should be our right to decide what is best for our bodies. There are no harmful effects like there are with the pharmaceutical industries toxic hormones. This is all about money and that is disgusting to me that our health is not a priority. Please allow us to continue having access to these hormones. Thank you
Don’t relegate your own family members to these limits to our health care options.
Healthy future
I have been taking compounded estradiol for years – helped my health so much
and my local Walgreen pharmacy has no problem making this medicine for me.
Please do not just take it away – there is no other ‘natural’ product like this.
if the CDC is worried about not making any money on this – please consider that
they will save money on my health needs – I am healthier in many ways using this
compounded medicine.
This affects me personally. My health has been greatly improved since I started using my compounded hormone cream. Please do not take that away from me! My compounding pharmacy is a wonderful facility, super careful, super informative. They have been in business for years and provide a very valuable service to our surrounding community. These attacks on our health care have to stop! Enough is more than enough.
I already commented that as a woman, retired professional nurse, wife and mother I write to urgently ask that you support compounded bioidentical hormones. The FDA and NASEM are trying to deny women’s access to these individualized medicines, especially estriol, because they compete with Big Pharma inferior product. Big Pharma only has HRT (Hormone Replacement Therapy), their one-size-fits-all “horse urine “ therapy, that exposes users to breast cancer and cardiovascular diseases. My mother died of breast cancer so this is very personal to me.
Sign on to the congressional letter supporting cBHT, a natural, effective and far safer alternative. Big Pharma does not have, and should not have, a monopoly on health remedies and medicines.
Ungag doctors so that they can share with patients the benefits of supplements and natural treatments for COVID.
I urge you to support the letter asking the FDA to protect consumer access to compounded bioidentical hormones.
People deserve the right to access hormone replacement therapy if they so choose.
I ask that our U.S. government elected officials support and protect consumer access to compounded bio-identical hormones. The health benefits of bio-identical hormones are extremely important, including improved bone density and urinary tract health for women. There is no reason for compounded bio-identical hormones to be banned except to give a monopoly on hormone drugs to the pharmaceutical companies. Compounded bio-identical hormones are just as safe, if not safer, than whatever hormone drugs the pharmaceutical companies develop, so clearly, safety issues are not a factor.
Please know that many women have benefited from Compounded hormones, I have used them myself. We should have this option available to women and men who could benefit.
FDA is totally out of control. They claim that they support medical science, but their actions show us otherwise.
Case in point is the Wuhan Virus. There are a ton of practicing physicians in the US and in other parts of the world who are using Hyroxychloroquine with zinc and zpak early in the treatment of the Virus, but the FDA nor CDC supports that. Instead, they support treatment options that may lead to death, especially for the older population.
This FACT and the fact that Dr. Anthony Fauci supported HCQ for treatment of a cousin Virus named SARS in the past proves that FDA and CDC are in the pocket of Big Pharma. This incestuous relationship needs to stop now!
For those who cannot connect the dots regarding my above comment, what has happened to HCQ is exactly what is happening with bio- identical hormone treatment options. Medical Science is half dead here in US.
Women need Bio-identical HRT from Compounding pharmacies because:
1. Women don’t get what they need approved by the FDA
2. OBGYNs are taught HRT from Drug Companies, not in Residency
3.Individualized medicine is the future and Compounding pharmacies allows doctors to individualize hormones, doses and delivery systems.
I am tired of Big Pharma trying to take away our compounded drugs. They don’t make them or I would buy them. I have to use a time release Thyroid hormone 3–this is the only way I can get it.
My husband has to take Thyroid 3 also, in the time release form.
I don’t want to take cancer causing Estrogen so I take safe estriol in compounded forms made for me specifically.
I have dry eye syndrome–the only medication is compounded DHEA put on my eyelids.
I use compounded forms with gratitude for it keeps me from the horrible side effects of uncaring pharmaceutical companies’ drugs.
We are older and need these hormones now. For 60 years we were healthy and cost Insurance companies zero We need help for the next few years. WHY DOES THE FDA THREATEN AND WAR AGAINST US? ARE THEY MAKING MORE MONEY BY THEIR ALLIANCE WITH DRUG COMPANIES??????