Bioidentical Hormones: Some Good News, Some Troubling News

March 14, 2019
Category: BHRT

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 healthcare, was developing commercially available bioidentical hormone drugs and had 31 patents relating to bioidentical estradiol and progesterone. Our concern was that TMD could corner the market, in particular the patent rights, on bioidentical hormones and completely block compounding pharmacists from making these important medicines.

The good news is that important women’s bioidentical hormone preparations appear to be safe from this threat. Because standard preparations used in bioidentical hormone replacement therapy (BHRT), such as bi-est (80% estriol, 20% estradiol) and tri-est (80% estriol, 10% estrone, 10% estradiol), delivered in a cream consisting of long-chain fatty acids, have been prepared the same way for more than twenty years, these compounded preparations are protected from pharmaceutical company ownership. (Twenty years is the life of a patent; after that time, a patent can no longer be enforced. Therefore, if compounders have been making medicines the same way for twenty years, they are protected from being sued for patent infringement.)

Although protected from Big Pharma, bioidentical hormones like estriol, estradiol, and progesterone still continue to be under threat from the FDA. As the agency decides which ingredients compounding pharmacists can use to make medicines, the hormones mentioned above have been nominated to the “Demonstrably Difficult to Compound List.” If the FDA decides to put estriol and other hormones on this list, we will lose access to compounded bioidentical hormones and estriol in particular, since there is no FDA-approved bioidentical estriol product.

The prognosis isn’t good. Over the last few years, we’ve watched the FDA’s Pharmacy Compounding Advisory Committee (PCAC) routinely vote to recommend banning safe, natural medicines from compounding at traditional pharmacies. We’ve argued that PCAC is a stacked deck representing the opponents of compounding—there is only one actual compounder on the committee, and it is a non-voting member.

The public must stay involved to prevent the worst from happening. ANH-USA has been leading the charge to protect estriol and other bioidentical hormones from an FDA ban. As a result of our members’ activism, the FDA has called for a study on BHRT to be done by the National Academies of Sciences, Engineering, and Medicine (NASEM).

To us, this is a qualified victory. ANH activists have demonstrated that the FDA would face a backlash if they banned compounded hormones. By calling on NASEM to study BHRT, which the agency will claim is an “independent” analysis, the FDA is giving itself cover should it pursue a ban later. When the public blowback comes, the agency can say, “It wasn’t us! It was a panel of experts at NASEM.” If we weren’t holding their feet to the fire, the FDA would not bother with this intervening step.

We hope the NASEM committee offers a truly independent and balanced assessment of bioidentical hormones. At the first public meeting to discuss the study, the FDA seemed to tip the scales against compounded BHRT. One presenter, though not a member of the study committee, seemed to think that compounded BHRT was nothing more than a marketing ploy, despite the fact that patient satisfaction with compounded BHRT is extremely high and there is a wealth of evidence to recommend BHRT over conventional hormone replacement.

What this means is that compounded bioidentical hormones are still in jeopardy, but our activism is working! We must continue to exert pressure on the agency and remind them that the lives and wellbeing of millions of patients are at stake.

Action Alert! Tell the FDA to protect patient access to compounded BHRT. Please send your message immediately.

8 responses to “Bioidentical Hormones: Some Good News, Some Troubling News”

  1. D Tretter says:

    Please protect access to compounded bio identical hormone therapy. There are many many women who can not use conventional hormone therapy. Please protect our right to choose what we use.

  2. jc ross says:

    Millions of women have safely used BHRT compounded bi est, progesterone and estriol creams for various menopausal symptoms with no harm that has been a God-send to women who dont want the HRT. It is outrageous that any man or government would step in to stop the freedom and rights of women to make choices for themselves. Women have a right to chose compounded bio identical hormones without intrusion . I am personally shocked that our rights are being infringed under the guise of protection which is outrageous. I personally have used compounded topical hormones safely with no side effects including bi est 50/50, estriol vaginally , and progesterone creams as well as a small amt of testosterone cream for over ten years . My joints no longer hurt, have more energy,can function like before menopause with safe bhrt compounded hormones. Before compounded topical hormone creams i could not walk up a flight of stairs from joint pain, could not sleep, had no energy and felt like i had aged to 100 all in response to being menopausal. It was shocking the turn around when i tried topical hormone creams. I dont want any hormone taken internally that goes through the liver and that is my right. No one knows what it is like when you hit menopause until you are that person and compounded hormones gives you your life back and your function. It is very strange that millions of other drugs are on the market from Big Pharma that cause harm but they are going after compounded bio identical topical creams attacking women in particular. This is alarming that the FDA is attempting to remove menopausal womens access to compounded topical hormones creams and I beg you to leave women alone to make decision ON THEIR OWN. If you dont like it, put a warning label on it. Women are intelligent enought to make their own decisions. Tylenol or a Aspirin etc all can be used incorrectly thus the reason for warning labels., but please leave BHRT TOPICAL COMPOUNDED HORMONES CREAMS ALONE.

  3. paula braun says:

    I have been using BHRT for many years now – I am 84 years old-and have NEVER had a bad reaction. It has been a blessing as I am strong, active, full of energy and do not take any medicine other than this.
    PLEASE allow us the intelligence to continue with somethng that works and has worked for many women over many years. I am monitored with a yearly hormone test to make sure everything is in order and give credit to the Tahoma Clinic for working with me and Key Pharmacy for providing my medication.
    Do not allow this to be discontinued – I beg you to take our comments seriously and let us be the judge whether we want BHRT. I know I do

  4. Joan Brandt says:

    Please pro tech patient access to compounded BHRT!!
    The patient and his or her doctor should be able to determine what is appropriate for him/her.
    Pharmaceutical companies are in business to make profits. Any effort by pharmaceutical companies to influence the FDA on this matter should be looked at with suspicion.
    Compounded BHRT has helped women safely or a long time. Please do not restrict our access to it!! Thank you.

  5. Carolyne Shapiro says:

    I need my compounded bio identical hormones – if I did not have, the quality of my life would be what it was and that is awful for 16 long years – nightmare. I work with a physician who has treated women with cBHRT 26 years and feel very safe and thankfully well now due to.
    For me I cannot live without truly and to take away would be cruel and a real nightmare for one million women who choose cBHRT.
    Please PLEASE have a heart and do not ban these so needed hormone form us! Surly if it were your mother, sister or sife or daughter taking you might really think differently – we al beg of you to truly educate and learn that neither cBHRT or HRT cause cancer or ill health!! TY so very much!! ALL of us women truly appreciate it so very much!!!

  6. Eleanor Burke says:

    My compounded bio-identical hormones have changed my life for the better! I am 67 years old and was beginning to have numerous body pains and stiffnesses. I had lost my enthusiasm for life and lifetime hobbies. My compounded bio-identical hormones gave me back my interest in life and reduced or removed my aches and pains! I can‘t imagine not having my cBHRT and will fight tooth and nail to keep my access to them!

  7. Mindy Jollie says:

    That’s interesting that female bioidentical hormone preparation doesn’t seem to be threatened by the FDA, while others do. I imagine that it’s good for many medical conditions to have this type of hormonal treatment available. My friend has a testosterone deficiency, so she’ll have to look into what kind of treatment she’ll receive.

  8. S Schatz says:

    YES, I want to continue to have access to compounded BHRT.

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