FDA Push to Ban Bioidenticals Moving Forward

May 14, 2019

An update on efforts to preserve access to bioidentical hormone replacement therapy. Action Alert!

We’ve been telling you about the FDA’s efforts to curtail or eliminate patient access to bioidentical hormones, as well as potential intellectual property challenges from the pharmaceutical industry that would prevent compounding pharmacies from preparing these important medicines.

We’re happy to report that compounded bioidentical hormone medicines appear to be safe from intellectual property challenges. Recall that our concern was that pharmaceutical companies were patenting bioidentical hormone recipes, and we were worried that these patents could be enforced against compounding pharmacies to prevent them from making the medicines that millions of patients rely on.

Earlier this year, we reported that compounded estrogen was safe from claims of patent infringement. Further legal research has confirmed that compounded progesterone and testosterone are also safe from this threat. Our research demonstrated that compounding pharmacies have been compounding hormones suspended in oils for more than 20 years, meaning these recipes are safe from pharmaceutical 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.)

Additionally, there are FDA-approved progesterone and testosterone drugs—and generic versions of those drugs, which means that any patent protection covering the FDA-approved versions has expired.

This is great news for the millions of patients who rely on compounded hormones to stay healthy.

Unfortunately, the danger isn’t over. The FDA is still considering whether or not to ban compounded bioidentical hormones. The agency has in fact asked the National Academies of Science, Engineering, and Medicine (NASEM) to consider whether there is a clinical need for compounded bioidentical hormones. As we’ve argued before, we think the FDA still wants to ban compounded hormones, but the fear of public backlash has caused them to put on the brakes. This way, the NASEM report can provide cover when the FDA goes through with its ban.

We have to keep up the pressure on the FDA, letting them know that millions of patients rely on these medicines—and we’re watching the agency’s every move.

Action Alert! Write to the FDA and their Pharmacy Compounding Advisory Committee, telling them NOT to ban compounded bioidentical hormones. Please send your message immediately.

30 responses to “FDA Push to Ban Bioidenticals Moving Forward”

  1. […] Posted May 17, 2019 An update on efforts to preserve access to bioidentical hormone replacement therapy. Action Alert!  Read more.  […]

  2. Sherri hudgins says:

    Do NOT ban compounded bioidentical hormones. They help so many.

  3. Lisa Henson says:

    To members of the FDA and their Pharmacy Compounding Advisory Committee, please do NOT ban compounded bioidentical hormones. These medications are greatly needed. Consumers have the right to choose which medications they want to use. I use these hormones and could not exist as a sane person without them. Please allow me the right to choose which medical treatments I want to use in my own body. Thank you for your consideration.

  4. Bb Nibbom says:

    Do not ban compounded bio identical. Some people are unable to tolerate standard products & some people believe bio identical to be more appropriate. Thank you.
    A research Nurse.

  5. Christi Gangl says:

    I’ve been on compounded bioidentical hormones for 16yrs. They have been life changing to finally find balance for first time in my life. Once one hormone goes down they all do and I already have thyroid problems. Bhrt is the next key to balancing and protecting my body as a whole. My organs bones brain etc. My compounding pharmacy gives me clean products that are natural. I will never ever do synthetic hormones. And bhrt in cream form is what I consider safest method and natural to what our body used to make.

  6. Marly Rey says:

    I believe BioIdenticals should NOT be banned!!

  7. TEALA says:

    Do not do this our meds are needed and I don’t want to use horses urine and torcher a horse for our meds

  8. Deborah Hill says:

    Hello, I am a 63 year old female who has been on Bioidenitacal hormones for over 15 years. They have worked so well that I am not experiencing the massive problems that come along with aging and surgical intruptions of producing the proper amounts of hormone that all humans need.
    This has help me stay a functional and contributing member of society.
    I fully expect NOT to need the intervention of both Doctors, labs, hospitals and of course pharmaceutical when I reach 65. This will reduce the dependency to “ foot the bill” of this country which I Love, via Medicare.
    Furthermore I feel it my constitutional freedom to have an option of chemicals (pharmaceuticals, which are not natural to my body…ie toxins, and side effects) verses a natural way to address my body and its health.
    I will keep fighting for my rights to have a BETTER way to address my health, and don’t believe that a viable legal pathway should be blocked, because of Big Pharmas influences.
    I join the fight NOT TO BAN BIOIDENTICAL HORMONED!

  9. Jennifer proctor says:

    I have been on bio identical hormones for 5 years since my hysterectomy and it has literally saved my life!!! Brought me back to life!!! I absolutely need my hormones!!

  10. Dr Tracey Turner says:

    Please understand that compounded bioidentical hormones are safe and necessary for the health and mental wellbeing of everyone. As a woman in her 50’s I can say that having my doctor be able to tailor the dosing of my transdermal hormones has resolved a dozen major health issues, including debilitating depression and insomnia – both of which have now resolved. Compounded hormones have saved my quality of life. No improvement occurred using the standard low-dose commercial patches. I truly owe my life to compounded hormones and feel very thankful they are available.

    As a scientist I have taken interest in the biochemistry of hormones and their interactions with their receptors. I have taught the basics of cell function to pre med students in my university position in MD. So, I have a real understanding of the science behind my statements. Achieving the optimum levels of hormones can only be done via compounding pharmacies. These are essential for human well being. These are vital. Please do not allow anyone to take away access to these life saving compounds just because the commercial world wants to put profit over health.

    Summary: there is a very strong NEED for compounded bioidentical hormones. They offer the ONLY working solution for many serious health problems. My mental and physical health are a testament to this.

  11. cindy cox says:

    stop taking our natural products away.Stop forcing pharmacy horse urine on us

  12. Martha Calais says:

    Please do not ban compounded bioidentical hormones. After having had a hysterectomy in 2001, they gave me my life back! I can’t imagine life without them.

  13. Pauline king says:

    Big Pharma pushing for this I am sure. THEY ARE WITHOUT CONSCIENCE Please keep bioidentical hormones made by Pharmacists available to the many women whi benefit greatly .

  14. Big Pharma pushing for this I am sure. They are so disgusting. Leave Biomedical Hormones alone. Pharmacists prepare the Bio-Identical hormones that help so many women – desperate for relief..

  15. Debra Zieger says:

    Please, please do not ban bioidentical hormones. I tried the regular homes , I was sick, foggy in the brain and so many side effects. My bio identical are made for my body chemistry. I have been feeling completely normal since receiving them. I’m very nervous to ever be off them.
    Please consider the individuals who need these to function and live a normal life.

  16. Please do not ban compounded bioidentical hormones. Make them available to the pharmacies and make them absorbable through the skin in compounds that are safe and effective but let women have a choice if they want to use the BHRT and are getting benefits from them. I have been using hormones for 12 years and would not be the same person today had I not been taking them. Changed my life literally! Have too many examples to show that replacing hormones is necessary for females as we age and does improve quality of life as well as how we age.

  17. Elena Yoder says:

    Biodentical Hormone Replacement has been the only thing to help my health in the last 10 years. Banning this medication will devastate and possibly lead to the deaths of many women. We need these medications! Nobody has the right to take away effective medication from anyone else. We deserve the right to choose about the kind of hormones we take. I wasn’t given the choice as a young woman. Compounded biodentical hormones should be readily available to any woman who wants it.

  18. Jason yoder says:

    Do NOT ban compounded bioidentical hormones

  19. S Lentine says:

    FDA please do NOT ban biodentical hormones. They are just too important to our health. No ban! Thank you!!

  20. Angela Vasquez says:

    Stop infringing on my medical choice and freedom. I have every right to BHRT.

  21. Trudy says:

    Please do NOT ban compounded bioidentical hormones.

  22. Erica Vinson George says:

    Please do not take away BHT!

  23. You must not ban the compounding of bio identical hormones!…these are the only things that work for women in perimenopause and menopause!!..I’m 61 and cannot take anything to have a quality of life other than the compounds !.. my life was very dismal before getting these bio hormones!!

  24. Please do not ban compounded bioidentical hormones. These products help millions of us function better health.

  25. TAMMIE CROLE says:

    STOP TRYING TO MAKE MY DECISIONS FOR ME! IT’S MY BODY NOT YOURS! IF I WANT OPTION YOU STAY OUT OF IT!

  26. Alicea Logan says:

    My life depends on my bio-identical medication! Without it, I was noticed how quickly I was beginning to age.

  27. paula braun says:

    I have been a happy user of Bio-identical hormone replacement for many years (I am 84 years old), Have a yearly hormone test to see how I am doing and highly recommend the Tahoma Clinic who have been watching over me for years – never had any problems, am very active, take no medicines at all and rely on BHT to help keep me going, PLEASE do not get in the way of a successful program which helps. Are you just going to urge us to take unnatural concoctions (Prempo, Provera) in order to give more money to pharmaceutical companies? If not, then leave us alone. We can judge our own health

  28. Dianne says:

    Bioidentical hormones saved my life after surgery.
    We loose our freedom as a gitizen and patient if they wre banned.

  29. Carolyne Shapiro says:

    I need my cBHRT badly. So many women need their cBHRT badly — we choose to take this we do – to take away would be taking away our lives. To take it away would also be taking away our right to choose between HRT – BHRT or cBHRT!!!!! This truly cannot happen as the quality of life for so very many will be horrible affected – I mean REALLY HORRIBLY AFFECTED!!!!!!!!

  30. Annette says:

    Howdoido this in uk

Leave a Reply

Your email address will not be published. Required fields are marked *