FDA Rigs Process Against Estriol, Other Bioidenticals

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 of estriol and other compounded, bioidentical hormones from an FDA ban. Please take action by signing our petition to the National Academies of Science, Engineering, and Medicine (NASEM) study committee, urging them to consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).
To briefly recap where we are: estriol and other 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. The FDA convened a NASEM committee to study the clinical utility of treating patients with cBHRT; the findings of this committee will be used by the FDA to make a final decision on the fate of estriol and other compounded hormones.
NASEM has conducted several public meetings to date on cBHRT. During these meetings, the FDA invites experts to present to the NASEM panel, and to us it seems that the FDA is stacking the deck against compounded BHRT. What’s also clear is that the NASEM committee members lack a fundamental understanding of how cBHRT is used to treat menopause, meaning that committee members are susceptible to the FDA’s bias.
What happened recently all but confirmed our charge that the process is rigged against estriol and the other hormones. NASEM sent out an announcement seeking nominations for speakers who “regularly prescribe cBHRT or pharmacists who extensively compound BHRT, and who are willing to share relevant data to inform the committee’s work.”
Sounds good, right? It would be, except for the fact that the request for nominations was sent out the afternoon of Thursday, October 10, and the deadline for nominations was prior to Monday, October 14 (Columbus Day), giving the natural health community just one business day to prepare a response.
ANH-USA and allies have, of course, submitted suitable speakers to put forth the case for protecting compounded estriol, estradiol, and progesterone, but this recent episode simply demonstrates the uphill battle we are fighting against the government to protect cBHRT. Sign our petition below demanding that NASEM give a proper hearing to actual experts on cBHRT.
Action Alert! Write to NASEM, the FDA, and Congress, telling them that the millions of women who use cBHRT demand that it gets a fair hearing. Please send your message immediately.

278 comments

  1. Compounded estriol, estradiol and progesterone must be available to all who want and need them in the USA.

    1. So much suffering has been placed upon me because of FDA regulation. I have been permanently injured and disabled because of what the FDA thinks they know. Please Please let me and my doctors be in charge of what substance is right for me. STOP banning something that someone needs. Your bans injure mame and sometimes kills.

  2. In the name of God we should have the freedom to choose our treatment. Its a personal thing that should be a God given right! I’m not asking the government to pay for anything I want the right to choose.

  3. The FDA is in the pocket of Big Pharma so this is just over reach to protect Big Pharma’s greed and control.

  4. These products work and are cost effective. Please don’t put even more of our money into big pharma, they are baron robbers.

  6. Please do not ban bio-identical hormones and our access to them. We are NOT pregnant mares and do not want to support the inhumane conditions mares and their foals endure to produce the product for Pfizer. We do not have the financial “donations” and lobbyists and that Pfizer does.
    NASEM, FDA,Congress? I thought you worked for your constituents…we , the people…the millions of us who prefer to use CBHRT demand you ensure it gets a fair hearing. We are watching….and we are voting.

  9. The Federal Drug Association! Owned wholly by the Pharma- and Chemical Industries!
    All those actions that are going against the stated reason for existence of that very agency are committed on purpose and with one single purpose- to get The People upset enough to call for its abolishment.
    All the so called secretaries of those agencies need to be fired and prosecuted for violating their oath of office, to say the least. Really, they are all criminals!

  10. There is no need to make changes where there have been no problems. Do not restrict our access to support ourselves.

  11. Stop the madness…we need these and they have caused no harm…I am healthier when taking my HRT…stop giving in to the big pharmaceutical companies.

  13. My wife and i have been using compound hormones for over a decade and believe they have significantly improved the quality of our life. Please donot allow the FDA to interrupt our access

  14. Transdermal Estriol is the safest hormone I can use to solve my post menopausal health issues. It would be criminal to take this away from women like me who need this therapy.

  15. The FDA is supposed to be for the good of the people and the environment! Stop thinking of YOUR pocket book. The top .01% is just that, .01%! There are more of us than you!!!

  17. There are many peer reviewed studies, as well as the positive experiences of millions of patients, that should be considered in any serious assessment of bioidentical hormone replacement therapy. I strongly urge the NASEM study committee to seriously consider all of the evidence before making conclusions on the safety and efficacy of this treatment that has significantly affected the quality of life of countless patients in a positive way.

  18. Estradiol is a Godsend for women who suffer from hot flashes into their old age. Keep it available for women who need it.

  19. Please allow a fair hearing and time to prepare for hearing for compounded hormones, cBHRT.

  20. The interests of the wealthy and the greedy are served by the FDA, not the interests of the American people in general. A large number of prescription drugs are either ineffective or dangerous, or both. Over 200,000 Americans die from prescription drugs. Prescription drug death is the sixth leading cause of death in our nation today. The FDA has failed to protect us because are protecting the profits of the wealthy. Our democracy has failed!

  21. Please do not rule against cBHRT’s. They should be available for health care providers to prescribe for their patients. I have had some experience with compounding pharmacies and advocate for their access to these medications.

  24. NASEM & Congress,
    The FDA has repeatedly showed bias on RX issues. How about we allow GOOD Medicine to be practiced. This includes appropriate compounding!

  25. Government has no right to prevent anyone from using natural products used for health. Government has allowed pharmaceuticals to take these natural products, change them from heir natural state causing physical harm to the user, and make so much money under the guise of healing people. I just lost my wife to these leaches. Their so-called medicines just made my wife sicker and the few doctors who were wise to this were outnumbered by those who continued to push these modified natural medications.

  26. If one has no thyroid we need to survive the natural dessicated thyroid homrones. We also need to balance our hormones which included, forms of estrogen, progesterone and testerone. Please leave them alone already! You may need them in the future too!

  27. I totally support the proposal of cBHRT experts be allowed to present to the NASEM Committee.

  28. I have been on bioidentical hormone replacement since having a total hysterectomy and experiencing very adverse effects from that operation. Low sex drive, painful sex, dry skin, mood swings or no mood at all, the list goes on. It was not until I had my hormone levels tested and started the bioidenticals that I experienced relief and stability. DO NOT ban the use of bioidenticals. I will go to Mexico or Canada to get mine. I should not have to do that. And, if you are making this decision to ban them, you must be a man and my opinion of men in the past three years has dropped considerably.

  29. I have used BHRT for decades and am completely grateful for their support. A good compounding pharmacy protects is their quality control. Without BHRT I would be crippled, demented and physically in very bad health.
    There is no way that 24/7/365 days a year abused pregnant mares can make high quality estrogen products. Their cortisol levels must be off the charts.

  30. Estriol works. I’m not interested in the profits of pharmaceuticals. I’m interested in my own well being. I don’t need government making my health choices for me.

  31. Just remember, “what goes around, comes around!” The problem unrecognized by those of us partitioning our reality strictly in the context of the words we have at our cultural disposal, as has clearly been demonstrated in the “wing-out reactions the public has in response Trump policies promoted by the fantasy his pychopathic reality has imagined, is the physical repercussions and irreconcilable alterations our synthetic food-chain inclusions are making to nature and our food-chain!

  33. why ban something that enhances life?. women who suffer extreme flashes, don’t sleep, can’t function and have shortened life spans. Perhaps those who are opposed should experience what they do.

  35. I am reliant on access to cBHRT. Do not restrict or limit access for those of us that need this medication for our health! It is a critical component of my healthcare.
    Jennifer Warner

  36. The FDA is not on our side! They’re on the side of drug companies. They want to make safe, effective solutions for women illegal so that drug companies can make huge profits on synthetic drugs that don’t work well and cause cancer!
    Basically, the FDA has been a key piece in the chain of drug pushers!
    This makes me SO angry!

  37. Stay away from our bio-identical compounded hormones!! These hormones are necessary for my existence!! Go somewhere else and wreck havoc!!!

  38. Listen to the experts on this and give them a fair hearing. Millions of women have been using these cBHRT for decades under the guidance of medical doctors. If you don’t listen to the experts and give a fair trial, it is a corruption of justice just like we’ve seen in congress for the last 2 years.

  39. The FDA’s NASEM committee’s recent request for nominations of speakers who “regularly prescribe cBHRT or pharmacists who extensively compound BHRT, and who are willing to share relevant data to inform the committee’s work” demonstrates a lack of a good-faith effort to solicit such information, given that the committee’s announcement came out just one day prior to the deadline. Give experts cBHRT sufficient time to respond and present their case to the NASEM committee. This is not the way a government agency should be conducting the public’s business.

  40. Millions of women who use cBHRT are demand that it gets a truly fair hearing and not banned. Please listen and please be sure it does.
    Thank you very much!

  41. My sublingual estriol has made it possible for me to have a normal after a disastrous hysterectomy where I had no idea what it would do to me. For 2 years, I had very little sleep. All my Drs gave me sleeping pills, Xanax, Ambien, you name it… I even tried a seizure prescription because the side effects were very strong drowsiness. It want until I met Dr. Warner that I found out about sublinguals and I was finally able to sleep.
    Once again, the government is over reaching over something it knows very little about. Also compounding pharmacies make medicine affordable which is not what can say about the last 4 presidents who use that as a battle cry but never deliver.

  44. NASEM, FDA, and Congress,
    Let US decide if we want to take Bioidentical hormones! You should NOT make decisions regarding our health and wellbeing for us!

  46. Please work to help and protect citizens trying to nurture their own well being. Please use your authority to responsibly protect cBHRT use.
    Please act to give a proper hearing to actual experts on cBHRT .
    Let’s work together to make our society informed, better educated and healthy.
    Thank you for your help in these efforts.

  50. Removing access to bioidentical hormones is a tactic that will threaten the health of men and women for no discernible advantage to anyone except the pharmaceutical companies that manufacture the more harmful hormone drugs. It is unethical to do this, and it is unethical not to give a proper hearing to the actual experts on the subject. The millions of men and women who use cBHRT need a fair hearing!

  51. Do not take bioidentical hormones away. You will have to deal with a lot of women who are taking their power back. Do not
    let the the Medical Mafia have their way. Give us our natural medicine.

  52. I have been using bio identical hormones and am very happy with them. I do not want them taken off the market.
    Beverly Levitt

  53. demanding that NASEM give a proper hearing to actual experts on cBHRT.
    Action Alert! Writing to NASEM, the FDA, and Congress, telling them that the millions of women who use cBHRT demand that it gets a fair hearing!

  54. PLEASE consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT). I use bioidentical estrogen and will NOT go to artificial forms made by a major pharmaceutical company. Then I will just be without the help that my body needs.
    It seems that the natural health community was purposely left out (or given one business day) of the process to voice opinions. Please let the natural health community speak!

  55. As a woman of a certain standing and age, I will happily speak at length with anyone who will listen. I run a business, a Foundation, and have a family. And the last thing I want to maintain my health with is estrogen from horse MARE URINE (would you use it)? I strongly disagree with the FDA trying to regulate natural forms of Estrogen, progesterone, and Testosterone. All are components of treatment with less side-effects and less risk of cancer, and still correct women’s HRT needs. I USE PROGESTERONE, daily, with great benefit.
    I STRONGLY urge the FDA, NASEM and CONGRESS to look further into the millions of women who are using these supplements WITHOUT the risk of breast cancer, which traditional HRT creates…I have had friends die of this form of Breast cancer. Instead of banning great substances, why not go reconsider how the DRUG COMPANIES are dictating the policy at the FDA.
    Regards,

  56. Are you kidding me? I thought this was a free country-but no-you really don’t care about millions of people.

  57. Consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT)!

  58. Compounded bioHRT has made a huge difference to my health and well-being while transitioning through menopause. I will soon not be taking them any more as I’ through menopause now but they were always a safe and necessary means of getting through some very difficult menopausal effects. With the help of my doctor and my compounding pharmacy, I am so grateful for this gentle, safe and effective tailored to me personally bioHRT. Please make sure they continue being available for other women!

  60. How can opioids be allowed while they are killing countless young people and bioidenticals be feared. Bioidenticals have no deadly track record and absolutely no addiction problems! A perfect example of why people are more and more suspicious of the entire medical establishment and the products they PUSH!

  61. The form will not send as it doesn’t recognise a British postcode and one can’t complete the address fields with a UK county/region

  63. What ever happen to integrity?????? Without it – common sense and destruction follows. No one wins. NO ONE!!!!!!! Not the NASEM, FDA or Congress. I ask these three agencies to please wake up and rekindle their integrity and do the right thing for everyone’s sake..

  64. Bioidentical hormone therapy has helped my disturbed sleep. I do not want my right to take these substances taken away.
    Do the right thing and keep bioidentical hormones as options for those of us who benefit fro them.

  65. Allowing only one business day for speakers or pharmacists to respond to your announcement to discuss cBHRT is a sham. If you truly care about science, health, and medical outcomes then you must provide ample time for response.
    I am ashamed that a government office will stoop so low to exclude experts from speaking on a topic that is so relevant to millions of people in the USA.
    You must allow a proper hearing to take place and not turn NASEM into a joke committee. Do the right thing, the right way!

  66. I’m so sick of the depth of interference in the natural health community. Millions of people in this country are HEALING THEMSELVES, LISTENING TO THEIR OWN BODIES AS THE GUIDE. Yet, your unfair ‘process’ goes forward trampling on citizens, making under-informed decisions and stealthily influenced by those who stand to benefit from adulterating and patenting even natural substances that are healthy for humans, REMOVING them from access by our citizens. This acceleration of removal of natural healing remedies is NOT PROGRESS. LEAVE MY COMPOUNDED ESTRIOL PRESCRIPTION ALONE. BAN NATURAL SUBSTANCES FROM PATENTS. STOP PHARMA COMPANIES FROM FORCING PEOPLE TO TAKE THEIR PATENTED ‘SUPPLEMENTS’ that are available naturally.

  67. It is outrageous how the FDA is trying to push the agenda of the pharmaceutical industry by railroading the compounding pharmacies out of town. As patients who take bioidentical compounded hormones that are prescribed by our physicians, we are appalled about the threat that the FDA is posing to us in our pursuit of health and wellness. What we want is CHOICE, not to have our options limited further because of some profit motive, nor as a way for an impersonal authority to try to “protect” us from some risk. Those of us who take hormones know that the best solution is an individualized protocol, and one size does not fit all; thus the need for compounded prescription medications, including hormone preparations. We need our choices and options, and especially in matters of hormone replacement therapy. I ask those who represent us or who are in the position to have an impact on what’s brewing in terms of potential FDA regulations to fight for our rights to self determine our best course of action in conjunction with our doctors, and to not be subjected to limitations by a regulatory body that is apparently acting in the best interest of the pharmaceutical industry.

  70. I as a concerned citizen protest the unlawful decision by the FDA against Citizens Rights under the U.S. Constitution to ban the use of identical hormone replacement therapy by qualified doctors and physicians.

  71. Experts who know and understand cBHRT must be allowed a proper hearing. It is unsettling that only one business day notice was given to submit nominations for speakers. The FDA must continue to allow compounding for bioidentical hormones. Many patients need a tailor-made, compounded form w/o certain ingredients. Furthermore, the hormones are different than the traditional pharmaceutical HRT, which many patients have tried and can’t tolerate or were ineffective . cBHRT is an important tool for physicians and patients to maximize quality of life. While I do not personally use cBHT, I have people close to me who do and it has been a life-changing medicine for them. It is important that we protect the rights of patients and physicians to prescribe what works best for each unique patient.

  72. To NASEM, the FDA, and Congress,
    I implored you to consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).
    Estriol and other 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.
    NASEM has conducted several public meetings to date on cBHRT. During these meetings, the FDA invites experts to present to the NASEM panel, and to us it seems that the FDA is stacking the deck against compounded BHRT. What’s also clear is that the NASEM committee members lack a fundamental understanding of how cBHRT is used to treat menopause, meaning that committee members are susceptible to the FDA’s bias.
    Thank you for renewing your scrutiny so that these products are not banned in our country. It would be a travesty if they are.

  73. Please do not ban bio identical hormones as they are very similar to the hormones that our bodies made when we were younger. Bio identical hormones help many of us to feel better and they slow down the aging process. Natural healing remedies and doctors’ prescriptions should be available and affordable to all who need these treatments. The FDA should fight for all people’s right to be healthy and have affordable treatments with minimal side effects, and access to appropriate medical services whenever they are needed. We have the most expensive health care in the world and that is not okay. Don’t make things worse by banning healthful treatments such as bio identical hormone replacement therapy.

  74. I have been greatly helped by using Estriol cream. I really want to see this be a protected product for issues during menopause. I am a retired RN and stay well informed on health issues and feel this is a very good and safe product.

  75. The FDA continues to lose credibility in my eyes. The usurping of our right to choose how we treat ourselves medically is getting more disturbing. This agency would do so much better if it showed real intelligence when dealing with natural medicine rather than biased ignorance.

  78. I depend on estriol creme since it’s the safest for my health as a lubricant. Do not take away our freedom of choice!

  81. This is just nonsense – the desire to ban bioidentical hormones is mostly to force women to use big pharma drugs that have been proven to cause cancer. They want the money. Most of our “medicine” is just experimental and causes more harm than good. Listen to the commericals: can cause liver damage, internal bleeding, or death. I made that up but the real ones are just as bad or worse. You must remember pharmaceuticals destroy the body, bioidenticals or natural products protect the body and induce healing.
    PLease do not remove this helpful, productive product from consumers. We deserve better than big pharma and their money grubbing junk.

  83. I am 73 years young, and my doctor prescribes compounded ESTRIOL because of extreme hormone loss. I need this compounded drug as I age, to keep well and active! There is no pill for this! And the compounded cream is an extreme necessity for me to continue in elder life. FYI: A major chain charges over $350 for the same exact cream that my compounding local independent pharmacy gives me for $45. DO NOT THREATEN THE EXISTENCE OF THESE FAIR PRICED PHARMACIES OR ESTRIOL! OR MY ABILITY TO AGE IN GOOD HEALTH AND MOBILITY! Thank you.

  86. Cutting on what really works for our patients (BIHRT) that does not harm them, is a disservice by the FDA. We must fight back

  87. I do not want my compounded BHRT taken away. There are literally millions of women on these that would be incredibly unhappy and miserable without them. As one of those women I demand that it gets a fair hearing!

  88. It is way past time that the FDA is reined in. It is my understanding that the FDA is directly or indirectly controlled and funded by the big pharmaceutical companies to do their bidding. Who is the loser that is easy the American Consumer.
    Here is a question, when was the last time that the FDA and big Pharma actually cured a disease and not just treating the symptoms on a disease. Another question why is the cost of medications so high in the United States compared to their cost in other countries?
    These questions could go on and on. It want get better until the Congress of the United States holds the FDA and big Pharma accountable and breaks their death grip on medications and how and why they cost so much. For so little actual healing and curing of diseases. Does the pharmaceutical industry lie to the American people? You will have to answer that for yourself as I have. For myself. What do you think is it time for a change by voting out the legislator’s that benefit so handsomely simply being in Congress, hummm, I wonder why.

  89. Bio identical hormones are not being given the time they need for comments and public input. I am a very satisfied user of estradiol
    and greatly urge you to give a fair and open minded approval system for the thousands/ millions of women who use these hormones.

  90. How dare my rights to cBHRT be threatened! I’m steaming angry!! I see right through this horrid scheme!!

  91. What on Earth is wrong with the FDA? In a word— EVERYTHING. Always trying to “fix” things that are not broken.. yet, ignore things that are. Bioidentical hormones are paramount in the use of HRT.. for optimal health and safety. Non-bioidentical hormones are dangerous and cause health problems.. especially, in long-term use. Synthetics and equine hormones cause cancer, stroke, heart-attacks and various other health issues. The FDA should be dismantled and totally eradicated. They are a bad joke on humans.

  92. I’ve been using bioidentical hormones for 5 years now. They changed my life! Please keep them!

  93. I am a practicing physicians and all my patients depend on the safety and efficacy of Estriol and bio-identical hormone replacement. Why is this under assault. Patient are extremely happy with natural hormonal replacement.

  94. Estriol saved me, and I know it can save other women too. Leave our bio-identicals alone!
    Listen to us. Put the people first, not profits.

  95. Please give cBHRT a fairer hearing or millions of women will make their voices heard. It is an unfair process and borders on the criminal. People have the right to choose their health care and will not allow government officials to make decisions for them. If women can get a proven natural product,why should be forced to take an unnatural one?
    If you ignore this warning, pharmaceutical companies will be boycotted and this unfair practice will be publicized.

  96. This is ridiculous. Cipro is given out daily and cause more deaths and problems, but the FDA thinks it’s just fine. Of course, you are all taking big payouts from big pharmaceutical companies. Stop selling out for your own good, and start putting the people first. I know of others, and personally use compounded medications, which happened to be prescribed by my MD, who knows they work. Why would you block this unless you are personally benefiting from doing so? Do the right thing.

  97. Bioidentical Estriol exists in nature and like vitamins cannot be patented. Stop helping big pharma restricting our choices and forcing us to accept their toxic patented inequivalent garbage.

  98. PLEASE don’t take away our right to bioidentical hormones! Look at the research that is done by real scientists, not by drug company stooges.

  99. This proposed ban against cBHRT is ridiculous! Bio identical hormones have been shown to be less likely to cause cancer in women. The only reason the FDA wants to ban them is because pharmaceutical companies don profit off of cBHRTs.

  100. Natural bioidentical hormones have changed my quality of life and health!! I should be able to choose as an adult American Citizen which medical treatment regarding my life I want to take. It is similar to the “Right to Try” Bill the President signed in regards that it is my choice what medication I take for my body’s health. I have the sole responsibility of my health and life, NOT the government! Please don’t take this choice away from this American!

  101. To NASEM, the FDA and The United States Congress. I myself as well as millions of users of cBHRT demand that it gets a fair hearing!
    Gayno Mills

  102. To NASEM & Congress,
    There are a lot of women out there that replace their hormones. I can’t afford private insurance and need to get my scripts from a compound pharmacy.
    Please please do not allow the FDA to ban these hormones from being made at Compound Pharmacies. Health care is hard enough for us women out there.
    PLEASE STOP THIS!!!!!!
    Marianne Everett

  103. I am writing in support of cBHRT because of my grave concern that the current review is biased and not considering the facts. Bioidentical hormones are designed to work more in synch with a woman’s body than mass produced medications who have a one size fits all approach. Women are individuals who have unique individual needs. Closely working with a qualified doctor who adjust the cBHRT specifically for an individual woman and monitors the progress is an ideal system that every woman deserves.
    The pharmaceutical industry has long focused primarily on male health issues with women’s needs addressed as a second class citizens. Restricting cBHRT will not give women access to the women designed, individual approach that they could greatly benefit from.
    I politely request and also demand that women’s rights be considered in this process. Catering to the needs of the pharmaceutical industry’s needs for profit over women’s needs for competent healthcare in no way protects women or does anything for the greater good.
    Consider all the data and leave bioidentical hormones alone! Research is still being conducted that will address any questions that remain after a fair and impartial review of the data. Do not cater to corporate needs but stand strong for individual rights and individualized healthcare!

  104. I am 65 and have been using bioidentical estradiol , testosterone and progesterone for 5 years and have never felt better! I tried the synthetic estrogen and it did not work for me at all. Keep your hands off bioidentical hormones for women. NASEM should hear from experts who KNOW and use bioidenticals!

  105. I have used the estradiol several years ago during menopause as the synthetic hormones prescribed made me sick.
    It was a blessing to me and I strongly recommend it to other women. To discontinue estradiol would cut off options for women and favors drug and pharmaceutical companies instead of honoring women’s choices..

  106. compounded bio identical hormone therapy has a place in our medical system. Please do not remove this from the available options!

  107. I feel that the FDA should not interfere with the use of bioidentical hormone replacement therapy. I know that it is a much safer choice than the synthetic drugs available from the drug companies.

  111. Estriol is very effective for a number of conditions. It is imperative that it remain accessible to patients in a customizable dose i.e. compounded.
    It’s clear Big Pharma doesn’t like the competition from an unpatentable, affordable generic. So many Congress people are bought and paid for puppets of pharma co’s, which pay them millions per year to vote in their favor. Congresspeople get it into office by the people’s vote but once they are they work for who pays them the most, less than a year into office congresspeople have usually gained tens of millions of dollars into their personal bank accounts, largely from Pharma. This unholy alliance blocks citizens from affordable effective healthcare, as pharma lobbies to protect their profits.

  112. I trust the Pharmacy’s that compound Bio- Identical hormones. The one I take has relieved my Unbearable symptoms of night sweats and brain fog.
    In a democratic society I should have the choice of taking natural or chemical medications. As a Registered Nurses I have studied both in depth, and believe the Bio-Identical hormones work the best with the least amount of side affects or long term adverse reactions.
    Thank you.

  114. Bioidentical hormones are essential for hormonal health for female and male. And, they are cancer protective, not cancer causing.

  116. PLEASE keep your hands off compounded bio-identical hormones and compounding pharmacies. Leave it to a patient and her/his doctor to decide.

  117. Millions of women use cBHRT and it is important that this important medication get a fair hearing. These compounded hormones are safer than the synthetic ones and for these women more effective. You must consider all the evidence when investigating these useful and safe bio-identical hormones. More time is needed for the evaluation, and it would be correct to examine the medical records of volunteers who have benefited from bio-identical hormones.

  119. The FDA shows their prejudice on behalf of the pharmaceutical companies hundreds of times over. Ask why so many FDA retirees are now drug company executives. With this said please do not let the FDA take our freedom to use bioidentical hormones.

  120. The FDA requested qualified individuals who were willing to testify on this issue to please contact them. Then the FDA gave them one day. — ONE DAY — to respond. That’s outrageous!
    I used bioidentical hormones from a compounding pharmacy for many years and they helped me stay “younger” than my current chronological age of 76. I am convinced the FDA’s hostility toward bioidentical hormones and compounding pharmacies is that they present real competition to the pharmaceutical industry. The FDA should be protecting and promoting the health and well being of ordinary citizens like me rather than denying us beneficial treatments that do exactly that in order to further the interests of wealthy and powerful corporation like the Pharmaceutical Industry Companies.
    It’s infuriating when we have to fight our own government agencies for access to efficacious treatments the FDA bans to protect Big Pharma from competition. I comment on behalf of the millions of Americans who have lost and continue to lose formerly available medicines and treatments because the FDA decided to take them away for the benefit of wealthy corporations that don’t even need their protection. Some of the individuals who have been denied access to formerly affordable substances like insulin will suffer and die because Big Pharma puts their profits above all. And the FDA essentially looks the other way. This is unconscionable and I have to conclude there is no limit to the greed and cruelty we are subjected to.

  121. I have used compounded bio-identical estrogen (Bi-est) cream for at least 15 years. I have no side effects and only rarely get hot flashes. This bio-identical estrogen functions exactly as my own estrogen did before I went through menopause. Why would anyone use non-bio-identical estrogens that are foreign to the body? Those non-bio-identical estrogens are not going to function like the ones made by the human body, and so there are many side effects and hazards associated with them, and warnings about using them. I know that I wouldn’t be using them even if they were the only kind available. I would rather have the hot flashes than expose my body to foreign non-bio-identical estrogens. I am a MS Chemist and know that just a minor change in the construction of a compound can completely alter its function.

  123. The FDA, and Congress, telling them that the millions of women who use cBHRT demand that it gets a fair hearing!

  125. I urge you to consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).The millions of women who use cBHRT demand that it gets a fair hearing.Thank You.

  126. Bio identical Hormones saved my life. I was allergic to every standard Pharmaceutical hormone replacement post full hysterectomy at age 30. I deserve to continue to live a vibrant life.

  128. Compounded bioidentical hormone therapy has helped millions of women stay healthy in midlife and beyond. Removal of this would cause problems for many women who have felt much better taking cBHRT resulting in a lower quality of life.

  131. The extensive use of estriol in Europe for decades should be considered as evidence of the safety and effectiveness
    of this substance.

  133. consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).

  135. It is incomprehensible that the FDA will actively thwart access to quality healthcare by rigging a hearing against cBHRT. Shame on them. Countless women and men are maintaining their health and vitality, with protection against cardiovascular disease, stroke, and dementia, just to name a few. This is done with COMPOUNDED BIO IDENTICAL HORMONES…something a synthetic analog simply cannot accomplish. I believe this is backed by the pharmaceutical industry and driven by anticipated profit margins over the health and safety of the public.

  136. It is very clear to me that the FDA is in league with Big Pharma and is another Swamp that needs to be drained. The FDA regularly approves dangerous drugs that, by design, damages the patient in some fashion. This is Agenda 21 at work. The continual attack by the FDA against safe natural alternatives that usurps Big Pharma’s profits will be your downfall. In other words, we know what you’re up to. It is time to end your reign of abuse and tyranny and shut you down permanently. You have failed in your mission to provide patients with safe prescription medication. Greed has ruled you. God knows. He has recorded your vast sins against humanity in the Books of Heaven. See the Book of Revelation, Chapter 20 for what the future holds for you and your co-conspirators in Big Pharma. The end is nearer than you think.
    Vaccines are another weapon of Agenda 21 with their 206 toxic additives that are intended to harm our children and destroy the future of our country. It is time for Big Pharma to be put out of business and to be held accountable for the damage done to our children. Vaccines do cause autism!!!!!!!! May God look upon all of you and repay you for your evil. He’s prepared a special place for you in Hell.
    Biodentical hormones have had great results in those patients who use them. Synthetic substances like what Big Pharma makes are literal crap and not in sync with the body’s chemistry. Given that Big Pharma adulterates its drugs, there are many bad outcomes that result from using prescription medication. The list of side effects for all prescription medication is so great that it could wallpaper the universe. The spotlight is going to be shined on all of you soon and you’re not going to like the consequences once the facts are made known to the public. Truth always wins.

  138. We need to keep bio-identical hormones available as an option. I have used them and also the prescription hormone therapy, prior to that. The bio-identical is superior in my experience and the only reason to take them away is to give more money to the pharmaceutical industry. It is not in the best interest of patients.

  139. Since menopause I have used compounded bioidentical hormone replacement therapy. I am now 76, very active, feel amazingly good. It has been very good for me.
    Give a proper hearing to actual experts on cBHRT.

  140. It is unconscionable to try and take away the very things that help so many women! I urge you take into consideration all the good that cBHRT does for so many.

  143. I feel strongly that the millions of women who use compounded bio identical hormones, estriol, estradiol and progesterone, be given a fair hearing with the FDA. These hormones have given women a choice in their medical treatment. But big pharmacy companies don’t like this since they are missing out financially. Big studies are hard to come by since there is no money to be made by a pharmaceutical company’s trade name drug. It is difficult to finance research studies without money typically given by pharmaceutical companies. Why not realize that this what some women want or need and join hands with compounding pharmacies.

  145. As a Biologist, I am appalled at the clearly fraudulent process being used to railroad compounded bioidentical hormone replacement therapy . Millions of American expect the FDA to operate in a transparent and honest manner. WE the people demand fair hearings.

  146. I, and thousands of other women have had our physical and mental health saved by bioidentical hormones. I fear I would be disabled were it not for these life saving hormones. Just because Big Pharma can’t make a profit from these compounded hormones is no reason to take them away from us. Please provide a proper hearing where experts can speak.

  147. I have worked with cBHRT for the last 37 years as a naturopathic physician. Especially with regard to natural progesterone the option commercially are limited, and do not provide the flexibility to meet my patients needs.
    I urge you to not “fix” something that is not broken. When prescribed by a physician for an individual patient cBHRT is safe and effective.

  148. Estriol is the only good Estrogen and its Bioidentical Form, the very best way to provide this critical Estrogen to both men and women. The FDA is exposing itself yet again as lying in Bed w/Big Pharma and AMA to ruin the Health of ALL Americans. Where are their Scruples?? What gave Birth to those who would do this to Americans? How is Congress, AMA, Insurance and WHO so bought off to be Silent at this Time?

  149. Just because Big Pharmaceuticals don’t want these bio-identical compounds doesn’t mean they are useless. They do work for many, cost less and do the same job as those weirdly named chemicals that they are pushing! For these companies profit is all that matters, nothing and no one else!

  152. Don’t confuse bioidentical hormones as a whole with the compounded versions. My PDR lists 11 with several delivery mechanisms that could be prescribed. Surely the need for compounding is small.

  153. My wife and I, both octogenarians, have been using compounded bio-identical hormones for over 20 years and regularly use blood tests, under the guidance of physicians, to monitor hormone levels as well as supplemental indicators of health. The blood tests for both of us are normal with the exception of the hormone levels which are in alignment of middle age adults instead of the historically declined levels of elderly people.
    There is nothing magical about the conjugated hormones that would justify banning use of chemically equivalent to natural hormones. All the horror stories of cancers from hormone therapy are based on patients using pharmaceutical conjugated hormones.

  154. Please leave the bioidentical medicines alone. You simply do NOT need to be in control of everything – just let us have our bioidenticals and leave us in peace & better health. Some of us really don’t want you – Big Pharma – in our lives!

  155. I urge the FDA, NASEM and Congress to consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT). I have personally benefitted from BHRT along with millions of other women and compounding pharmacies play a major role in providing these hormones. Thank you for your consideration.

  156. this is yet another violation of women’s rights. they are forcing women to suffer or be forced to take pre packaged pharmaceutical components that are derived from incompatible biological sources. not to mention touching on the subject of the animal violations and slaughter for their equine urine. this is clearly about money and capitalists wanting to control women.

  157. TO WHOM IT MAY CONCERN: PLEASE DO NOT TAKE AWAY MY BIO-IDENTICAL HORMONES. THEY HAVE BEEN A HUGE BLESSING TO ME. I AM 78 YEARS OLD, RUN MY OWN BUSINESS, AM HEALTHY, ABLE TO CLIMB LADDERS OR WALK LONG DISTANCES ON ROUGH GROUND WITHOUT PAIN OR DISCOMFORT. I HAVE BEEN LOW IN THYROID FOR MANY YEARS AND TAKE COMPOUNDED THYROID. THERE IS A BALANCE BETWEEN ALL OF THE HORMONES AND I WOULD ESSENTIALLY WITHER UP WITHOUT THE BIO-IDENTICAL HORMONES. THAT WOULD PUT ME, AND FIVE OTHER PEOPLE OUT OF A JOB. I HAVE BEEN TAKING THE HORMONES FOR AT LEAST 25 YEARS WITH NO ILL EFFECTS. BIG PHARM HAS PLENTY OF DRUGS WITH WHICH TO MAKE THEIR MILLIONS, WITHOUT WIPING OUT THESE PRODUCTS. I TRIED THEIR PRODUCTS YEARS AGO AND THEY DID NOT WORK.

  158. You must allow a fair hearing regarding cBHRT. I have been using a biochemical compound for menopausal symptoms for years. I may be an extreme case as I began having menopausal symptoms at age 42 am still afflicted with them now at 69! Hot flashes and night sweats would fill my days and nights without taking a hormone replacement. At 45 my gynecologist prescribed HRT to relieve these most unpleasant symptoms. At 52 I was convinced that I should stop taking the PremPro that had been prescribed. All of those not flashes came roaring back. At that time I switched doctors and started using bioidentical cBHRT. I believed then, and still do, that they are a safer choice. I am now 69 years old. In January, February and March of this year I decided that I must surely be done with menopause. Afterall, it has been 27 years! (I am aware that this is highly unusual!) So, I stopped taking the compound. On a daily basis the only relief I got from the brutal hot flashes was to sit on my porch – without a coat (I live in upstate NY!) or to stand naked in my unheated, attached garage! After 3 months of this I decided to go back on the hormone replacement compound. My quality of life was suffering so I made the best decision for me. Please see that I can continue to make this choice for myself with the guidance of my very capable doctor.

  159. In the fairness of all women needing hormone replacement therapy, please give a fair hearing to the the experts on the subject. Thank you.

  162. Millions of women using cBHRT are demanding a fair hearing, Please help protect it. Thank you.

  163. Quick to okay poisons if Big Pharma is behind it and can make a profit. Is it passed on to you? Did any of you “In Power” remember even once in a while who you are supposed to be working for and protecting? Not enough money in it to really do your job? Quit and let someone with ethics do the job that’s being paid for by American Taxpayers’ dollars.

  166. Please do not ban bio identical hormone replacement therapy. I have used this for years and it really helps me.

  167. I am strongly opposed to any action the FDA may take to limit or deny our access to bio-identical hormones. As a doctor I know a great many people who are benefiting from these therapies. How we choose to treat our own health conditions should be our choice, not the FDA’s.

  168. First go after the artifical hormones that cause health issues. Leave natural hormones alone. Don’t you have some real issues to go after like the poions in the food supply.

  169. Please, FDA & Congress, give a fair hearing to NASEM so that millions OF MEN in addition to millions of WOMEN who use cBHRT will not be unfairly denied their actual, experienced health benefits.

  171. I have been using hormone treatment (Estrace then Estriol] for over 20 years, They have been a life saver enabling me to continue my active life style.

  172. Natural hormone replacement is a safe way for millions of women to manage their lives. The FDA should not impose unfair restrictions on Estriol and other products.

  173. I have been on bio dentical hormones for 4 years prescribed by my OBGYN MD. He has been in practice for almost 40 years. I rely on those hormones for my
    vitality. Please add me to the list to demand a fair hearing.

  175. I cannot send anything because of those stupid words that your site will not accept every time I type it in.
    Also, I will not type in anyone’s email address for anyone else.

  176. Please protect pur right to use bio identical hormones and compounding pharmacists. Let the choice be ours.

  178. Please allow the the development of an exhaustive and scientific hearing on the use of BHRT , such a boon when in the throes of menopause.

  179. Consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).

  180. We cannot let our bio-identical hormones be taken away! I have used them for over 17 years and I can honestly say I am healthier and in better shape than my friends who do not use them. Drugs prescribed for menopause manufactured by the pharmaceutical industry come with many serious side effects. I have experienced no negative effects from my compounded hormones in my 17 years of usage. I never intend to stop using them. Do not deprive me and millions of other women of this option!!!!!

  181. I absolutely need compounded hormones because of my serious allergies. They must be cumtom-made for me. Save compounded hormones. This is vital to women’s health.

  182. Please be reasonable in allowing creditable responses to excellent results. One business day is unreasonable. As an agency, you would not tolerate this if a response was requested of you, yet you are very willing to treat other responders unfairly. Please be fair.

  184. I once used (and millions of women around our country use) cBHRT. It worked well and I trusted it way more they the hormones that major pharmaceutical companies put out. These bio-identical hormones are needed and they caused less side-effects in me. Please consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).

  186. I am just one of countless women who have experienced positive health outcomes from using bioidentical HRT. I have tried the commercial versions over the years and reacted negatively. When reading the label on Estrace, for example, I discovered all kinds of endocrine disrupting chemicals. It sounded counterproductive to me, given that I was seeking endocrine balance. Why is Big Pharma fighting so hard to eliminate these healthful products from the market?

  188. I have been on bioidential testostorone for years now and very satisfied with the results Robert O. Hopkins

  189. Just because a rigged election brought in a corrupt president and a corrupt Congress doesn’t mean we need our entire government to be corrupt. WE THE PEOPLE prefer plant-based, bio-identical HRT. There is ample evidence that garbage like Prempro is poison and actually kills women who use it. Why would you want to mess with our best alternative? Why would you want to corrupt the process of approval? Get out of the big pharmaceutical corporation’s pockets and do your job like you actually care about THE PEOPLE you are there to serve!

  190. Please consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).

  191. “NASEM sent out an announcement seeking nominations for speakers who “regularly prescribe cBHRT or pharmacists who extensively compound BHRT, and who are willing to share relevant data to inform the committee’s work.” That was Thursday afternoon of Oct 10, and nominations of those who would speak on the subject were required to be in by Mon., October 14.
    It is obvious that the FDA intends to avoid hearing positive comments about the use of the bioidentical hormone replacements that have proven to be healthier and more effective for many millions of American women than the problematic offerings from Big Pharma; the people you use our taxpayer money to serve. You care not for the American people.

  192. I am going through menopause and need to have availability to choose what is right for my body.

  193. I have been using BHRT for years successfully and don’t know what I would do without them.

  194. I have been involved in the research behind why transdermal compound progesterone is important and have great data, on molecular side.
    further the TRAILs study just corroborated the huge Danish study affirming flat affect depression in a very high number of young women using OCP ( synthetic hormone contraceptives)orally and IUDs.

  195. I am almost 70 years old and been using cBHRT since I was 52! I am extremely healthy, no cancer, no osteoporosis, just great health!
    I attribute my good health to the ability to give my body what it needs, bio identical hormones, compounded to my yearly blood work results!
    Please give the topic a fair hearing!

  197. I find the compounded hormones very helpful with menopause and would like to continue to use them.

  198. So roundup and all the other chemicals the FDA is letting money paying companies putting in our food is okay. But helping women is not. It is time to decommission the FDA , it is a disgrace!

  200. Millions of women safely use bio-identical hormones. This issue deserves a fair hearing!

  201. I regularly use compounded bioidentical hormones, including estriol. It has made a huge difference in my quality of life and I do not wish to have this option taken away from me.

  202. Been on estrogen near forty years fighting to get for it half that time yes they lie keep this product on the market . My mom was on it until she died in her eightys.no cancer for and so far me either

  203. I respectfully demand that cBHRT get a fair hearing. Please be reasonable and extend the comment period beyond the UNREASONABLE 1 day that has been allotted.
    In your evaluations, please keep in mind that many people use a variety of nutritional supplements, herbs and many other forms of natural medicines with GREAT SUCCESS. Yet many of those whom which we have placed our trust in for agency leadership have frequently been against the American people by trying to prevent access to these preparations. A better plan would be to NOT penalize those who are responsibly and successfully using these products but instead provide increased educational resources or PSA’s for the public at large alluding to potential risks. It is totally unfair to cut off access to helpful products just because a small number of individuals have had problems! This type of government over-regulation is not helpful or beneficial. The argument could be made that automobiles are demonstrably unsafe and should not be allowed, because MANY people have had accidents. But what about the many, many, many, many people who have *not* had accidents? Should they lose access to that valuable equipment? Thank you for hearing my concerns.

  204. cBHRT, has given me back quality of life. I had such bad side effects with pharmaceutical HRT. Please do NOT ban estriol , progesterone and other cBHRT. Menopause for some women is extremely debilitating physically as well as emotionally and mentally.
    My Over all health has been restored! I am ME again.
    Please do not take away my option to have access to cBHRT. IT WILL BE EXTREMEMLY LIFE ALTERING FOR ME, as well as my husband and family. I could barely function before I discovered cBHRT.

  205. I am writing to writing you to urge you to protect cBHRT and the rights and well being of the millions of women like myself who count on this compound. This is the only HRT that I did not have an adverse reaction to. Please consider well the millions of women like me for whom this is the only workable option.

  206. I have been using bio -identical hormones: estrogen, progesterone and testosterone for the past 25 years (I am 81 years old) and have the blood of a 20 year old (seen through electron microscope ) no menopause symptoms and have a normal bone density. That the FDA would try to block my ability to obtain these hormones infuriates me. We must not let this happen.

  207. My good health depends on Bioidential hormones. Please allow continual compounding of these vital hormones to continue.

  208. I use bioidentical hormone replacement compounded progesterone and estriol. I rely on these medicines to control my symptoms without harmful side effects which I experienced taking Provera. Please do not restrict my access to compounded medications.

  209. As a very satisfied user of cBHRT, I join millions of other women to demand that it gets a fair hearing. I do not want to use Big Pharma products that do little, cause unpleasant or dangerous side effects, and cost more. Please, please protect consumers, NOT Big Pharma profits!

  211. My compounded bioidentical hormones are critical for my health!
    Other “chemical” hormones, which I tried first, wrecked havoc with my skin, brain functions and sleep which were all alleviated when I switched to the natural, compounded prescription made specifically for me based on my hormonal profile after my hysterectomy.
    What is the basis for taking away an option for women that they think has helped them so much? Why do male politicians/lobbyists care? Money must be involved somewhere…..

  212. These bioidenticals are A very essential part of my health regime since I have PCOS! My life is a foster withoutthese

  213. Hormone replacement has saved my life, made it bearable to live a normal life. why would you take this away from woman who need this. Please do not do this. We need a fair hearing on this issue. enough with taking everything away that helps people so big pharma can make money with harmful ways. please I am begging you give us a fair hearing -Please

  214. Please give the compounding physicians/pharmcists a chance to submit to review. Many of usbelieve in this process and feel all the facts should be presented.

  215. Bioideebtical hormornes can be made to meet the exact need of an individual, and w/o the toxic chemicals used by pharmaceutical corps. Insread please work on regulating chemicals in food, water, air so we can use less medications, and we as individuals and a country aren’t accumulating unworkable amounts of debt

  216. I use bioidentical hormones especially now because they help for my heart attack. I am 77 and need this also for my terrible hot flashes and to keep my female parts working like a young woman!

  217. As a user of BHRT, I strongly advocate for the doctors and the compounding pharmacies in the anti aging field of medicine. It is only smart and logical to be PROACTIVE with your health and not wait until your body breaks down and is subject to many diseases and health problems that can come with harmone loss. . Bioidentical harmones are the ONLY way to go when replacing your own lost harmones since your body recognizes them and can use them effectively. I would never even consider taking the synthetic harmones which have been proven harmful. I, and millions of other women (and men) who have a better quality of life with BHRT, demand that this topic gets a fair hearing and that this wonderful area of medicine be allowed to continue helping men and women alike. Thank you.

  218. I believe Bio identical Hormones are essential for health and healthy aging. I have incorporated Bioidentical Hormone Therapy into my family practice with excellent results and satisfied patients.

  219. I used compounded estrogen for atropic vagina and it is invaluable for my continuing health. I could not tolerate any of the creams manufactured and needed to have something compounded in coconut oil in order to tolerate it. Please do not take compounded estrogen off the market.

  220. NASEM,FDA, Congress,
    I’m one of the many women who has used natural BHRT. I’ve had to use Hormones for 46 Years. I’m now 86 . My ovaries had to be removed when I was only 38. Happily I’d had my children. This meant I was instantly Menopausal. In other words I had almost no female hormones. Now,because I have taken Hormones, even at this late age my bones are still strong . My heart as well. I’m told I look and act much younger than my age. The only medicines I take are BHRT, and Natural thyroid. My friends on synthetic hormones are not so well. I did have side effects from the synthetic form. one side effect which is not unknown but not emphasized, that I’ll mention was the necessity to remove my Gall Bladder after seven years of synthetic usage. . Luckily, after a few more years and other side effects, a well studied Doctor switched me to the natural form of hormones .
    As a person who has used both forms, I ask you to not interfere with the access to a natural , healthy and much less side effects- prone medication. For example, it has fewer additives than the commercial. . It works, It works safely. It is a very effective tool for Doctors to use along side the synthetics. It is a great alternative for many Women such as myself who do have side effects to the synthetics. My Compounding Pharmacist has no difficulty in calculating the correct dosage formula. With overall less “untoward “effects from this form of natural Hormone replacement why do you seem intent on forcing one to use a synthetic form that really does not agree with a rather large group of women ?
    I”m asking that you do not continue with this study without considering all the evidence . Allow the Compounding Pharmacists and Doctors familiar with the usage and preparation of these products the TIME to prepare and to speak to you. Medical matters , such as a women’s menopause and its complicated hormonal effects needs to be clearly explained to non medical persons by all those involved… Especially the facts of why a minority of some women do not do well on the synthetics. As a unbiased committee I think you would want to learn of the good it does and the “whys”, it works so safely compared to synthetic. It has been the case up to now that both forms can exist, side by side. Compounding Pharmacists are by law well educated and regulated. They have not complained that it is Demonstrably Difficult to Compound Estriol and other natural Hormones.

  221. GOOD THINGS are banned by trump
    BAD THINGS are not banned by trump, what kind of message this give all of us?.
    Our President does not care about the American people, only “his” pocket books and fraud dealings.
    Cut the cost to everything important we need, to built a crazy wall, for his ego-maniac..

  222. I use bioidentical HRT,prescribed by my endocrinologist to control my migraines,as well as other symptoms post menopausal
    I refuse to use equine based hormones due to cardiovascular side effects as well as the suffering induced on the pregnant mares confined with urine collection bags strapped to them.Let’s not even mention what happens to the foals.Pure cruelty!!

  224. I have been on bioidentical hormones since I was 65 yrs old. I am now a few months from 80 yrs old. I look and feel years younger than any one I come across that is close to my age. What a blessing bioidentical hormones have been for me.I do not have gray hair. My skin is without wrinkles. I have the incentative to keep my weight where it should be.I feel young. I owe it all to biodentical hormones. All I have to do is be realistic and look at others my age. I have no health problems. You cannot decide for women that want and need this presciption. Do not take this right away. There is no reason to. In fifteen years that I have been on the bioidentical hormones I can only say I feel better than most women my age. No side effects. No cancers. Please do not take this away from us. It is a wonderful cream that helps in so many ways. I have never had a single hot fllash or any health issue from aging. I contribute it to the hormone creams.

  225. I have prescribed hormones for 20 years. It is a great option for women for many reasons. Cost, individual dosing, and true bioidentical hormones for women with reduced side effects.

  226. It seems that important health decisions are being made suddenly by NASEM about bio-identical hormone replacement therapy (BHRT), without reviewing available evidence from all sides. It also seems that holistic practitioners were only given one day by NASEM to respond with reports. This is unacceptable protocol. I urge and demand a fair hearing on behalf of all patients using BHRT.
    Thank you.

  227. United States Government needs to Stop stonewalling alternate protocols. Protect the individuals rights not mainstream pharma/medical.

  228. Stop trying to control the female body!! We want healthy alternatives for hormonal regulation and balance!

  229. I have prescribed BHRT for hundreds of women for premenopausal and menopausal symptoms. These women have found relief from many symptoms and feel much better with the use of estradiol, progesterone and testosterone. After careful review of the literature and looking at evidence based research, there is no risk to the patient. Patients may require different dosing than can be prescribed by using manufactured medications, and thus require their prescriptions to be compounded. The compounding pharmacies that I use are regulated by strict guidelines and do frequent testing on their prescriptions.

  230. ALWAYS siding with the pharmaceuticals…. WHY? Arent you ppl SUPPOSE TO BE FOR THE PEOPLE, not corporations. It is to the point of PATHETIC of how GREED (pharmaceuticals buying govt) is in charge of our world… rather than common sense or compassion.
    The USA is no longer “Land of the Free” is it… thanks to the USA Govt… who loves to see its ppl enslaved, dependent on IT and BIG CORPS….. It IS a sick world we live in, thanks to GREEDY ppl scratching the backs of Greedy ppl. Sick, pathetic. I sure hope there IS a thing called Karma.

  231. I would like to know who is deciding to ban bioidentical hormones. I’m assuming it has to be males as they would have no idea how critical it is for women to have access to bioidentical hormones. I would not be alive if I couldn’t have them. One of the numerous side affects of menopause happens to be suicide. Did you know that? Please support me in life and DO NOT ban bioidentical hormones.
    Connie Gates

  232. FDA: I treat bone loss, muscle loss, alopecia, reproductive cancers, cardiovascular disease and post menopausal wasting in my office with biological hormone replacement therapy, including plant based Estriol It is very inexpensive and extremely effective in balancing post menopausal risk for some conditions. PLEASE don’t take this great therapy out of our hands. It is a huge mistake for thousands of women suffering from aging related conditions, and at risk for many severe conditions such as breast cancer, bone loss, hair and skin thinning, and much more. Given there is no other way to deliver such effective remedy for hormonal depletion, and it is very inexpensive and reduces society cost to our health care system, it would be a huge mistake to eliminate BHRT from natural plant based sources. Thank you for doing the right thing. Fr. F

  233. NASEM:
    As an American citizen who has been using estriol/estradiol cBHRT compounded preparations for my continuing health and well being I am astounded at the lack of time given to bring forth professional, expert Drs and Pharmacists on the subject. It seems that the NASEM are not interested in giving cBHRT a far review but are instead trying to railroad these onto the difficult to compound list. This is absurd. Compounding Pharmacists have been safely and effectively compounding cBHRT for many years.
    Your greatest concern should be holding your job in the light it was established for: to make sure that needed medications are affordably and safely getting into the hands of consumers that need them. Compounding Pharmacies have been delivering on all three points with cBHRT.
    I look forward to being able to fill my prescriptions with my local compounding pharmacist for as many years as is necessary for my health.
    Thank you.

  234. Bioidenticals have saved countless women from miscarriages long before they can get an appointment with their doctors. They have saved relationships when their doctors only solution is antidepressants or antianxieties synthetics that interfere with future functioning. They seem to always be trying to take us back to the Dark Ages… because there they had more control.

  235. What needs to be banned is the corrupt FDA, bought and payed for by big chemical, and big pharma; what’s next on your ban list, water, or chemical free food maybe.

  237. I’ve been using bio identical hormones for 20 years, my health and well being are way above average. Please continue to allow us this option.

  238. These products are of important use to millions of women. It is outrageous for the FDA to put its finger on the scale in favor of other products made by Big Pharma. Science is supposed to be intellectually honest, not hostage to the Pharmaceutical Industry!

  239. Please preserve our freedom to obtain compounded estradiol, estriol and progesterone. These are natural substances. Medical doctors have proven their safety in a 20 year study.

  240. For God’s sake, please give cBHRT a fair hearing. Don’t let NASEM, the FDA and Congress deny patients the freedom to choose alternative therapies in order to protect Big Med’s invideous profit mill!

  242. No worries if FDA is successful. Safe and natural pine pollen will balance all sex hormones. I was able to discontinue 3 bio-identical hormone prescriptions. (testosterone, dhea, progesterone)

  243. I am a Family Nurse Practitioner of 40 years and I regularly prescribe these very safe bio-identical compounded hormone replacement products. The CBHRT can be adjusted to the health needs of each woman so there is not a “Big Pharma fits all pill”. Our bodies and our life stage is very different from another woman’s needs/ requirements to feel well. In addition “PROGESTINS”/ SYNTHETIC PROGESTERONE or Big Pharma’s product causes breast cancer and other cancers in women. You will find these synthetic products in birth control pills, standard hormone replacement products, patches, IUDs. So why would any woman want to have her safe, easy to compound bio-identical natural progesterone that can be customized for her to be taken away and she is then FORCED to take a synthesized product that will damage her health or go without any hormone replacement?. When a woman is 9 months pregnant she produces over 800 mg of her own progesterone. If bio-identical progesterone was unsafe we would not have pregnant women! This is simply a GREEDY ploy of the FDA to line the pockets of their Big Pharma friends and close down the production of safe, easily compounded hormone replacement through compounding pharmacies. This is outrageous and dangerous to a woman’s health.
    I am Ingrid Edstrom CFNP, M.ED., CTT and author of Protect Your Breasts and I have a chapter on hormone balancing which was reviewed by 2 nationally known compounding pharmacists, Jim Paoletti, VP of the American Compounding Association and Carol Peterson who runs Women’s International Pharmacy.

  246. People should have access to bioidentical hormones. Some people need other forms of hormone replacement and keeping cBHRT accessible is the right thing to do.

  248. FDA will try anything to stop anything that helps patients. FDA ,we want a a fair hearing to give patients a chance to speak and be heard.

  249. I am a Board Certified Obstetrician and Gynecologist and regularly prescribe EstraDIol but NOT EsTRIol.
    The EstraDIol is the same molecule in Vivelle. birth control pills and other pharmaceutical industry manufactured products.
    Unless you are also planning on restricting these Estadiol big pharmaceutical company manufactured products, restricting or banning small compounding pharmacies from producing more affordable, accessible versions of these estaDIol and Progesterone products will confirm that this is not about protecting consumers, but about maximizing big pharmaceutical manufacturers profits and eliminating competition. You can have the EsTRIol, but PLEASE do not take the bioidentical, highly beneficial estraDIol and progesterone away from patients who need it.

  251. Compounded bioidentical hormone replacement therapy is an integral part of addressing the challenges of perimenopause and menopause for many women, especially those who cannot handle conventional HRT well or those who prefer not to use conventional HRT.

  252. I have been using bioidentcal progesterone since I turned 50 years old and I am currently 69 (19 years) It helps maintain the health of the vaginal mucous membrane. So many women in my age group suffer from vaginal atrophy and dryness. I have not. Studies have shown that bioidentical progesterone is necessary to remylinate the brain. This hormone is in short supply in the post menopause years. This is important to me because I have multiple sclerosis. This keep this valuable hormone available to all of us who need it.

  253. Dearest NASEM,
    This is not the impeachment of a president, these are actual lives you are dealing with. This deserves a fair hearing. This is not appropriately being taken care of. You are being biased and acting as though you have been bought out by those that really do not care about human being lives that are already structured and maintained with a process that has been working for a mass amount of people for over 20 years. To take it away will be disruption that is truly avoidable. It will cause devastation to those lives that are dependent on these compounds. If you really are trying to do some good. Then demand education for those that prescribe it. Start where it matters. Don’t just cut it off. Please leave the compounds alone. ALL of them!!!! Don’t be evil like the rest of the government. Stand up for the people. Do the right thing.

  254. I use Estriol and it’s very helpful. I want to continue using Estriol and don’t want to have it banned.

  255. Aloha,
    I am a believer and long-time user of bioidenticals including estriol. How dare anyone tell me it doesn’t work and it’s not safe? I’m a healthy 67 year old and need those medications to keep my good health.
    I am vigorously against actions taken to restrict bioidenticals especially when it’s clear the actions are being considered as a boon to big pharmaceutical companies.
    thank you for protecting the freedom and rights of those who know their bodies better than anyone else and should be able to determine what’s best for them.
    sincerely,

  256. Please listen & consider all evidence for continuing availability of bioidentical HRT that I am, and have been using, successfully and comfortably without negative side effects, for the past 30 years!!

  257. Until they (FDA) can PROVE that these bioidenticals are HARMFUL/Deadly/Etc… “they” should NOT have the authority to deny anyone from purchasing same!?!!!

  258. NASEM must give a proper hearing to actual experts on cBHRT & avoid the ban of this treatment. Women across the country depend on compounded bioidentical hormones.
    Stop blocking health care options for patients! Review & revise this attack on health products used & needed by millions!

  259. It is imperative that you consider ALL of the evidence in determining the clinical utility of compounded bioidentical hormone replacement therapy (cBHRT).

  260. Please listen to the bio identical hormone experts on how vital it is for women going through menopause to take this compounded cream.,I have used it over 10 years! It’s the healthiest way to take hormone therapy based on plants not chemicals!

  261. These bio-identical medications are common throughout medical prescriptions, because they are superior to synthetic medications. For example, just as in Thyroid medications, (bio-identical) verses synthetics. Thus, synthetics medications are all like parts of a watch that are dissembled on the table, is it still an effective time keeper, a watch?
    There is a reason why Armor Thyroid or other bio-identical are prescribed as apposed to i.e., Synthroid, a synthetic version, bio-incidentals will always work better and for some people it is crucial if their body will not tolerate or respond well or at all to synthetics. Reason based in elementary facts, i.e., the watch .
    Additionally, I a prescribed the bio-identical B vitamin L- methelfolate, because my body will not process the synthetic version which is folic acid.
    Thus, bio-identicals are sometimes the only solution, please keep them and do not shut down the options ( that seem based on lobbyist and companies that compete for dollars, rather than a true regard for health and wellness).

  262. Stop the FDA and their ideologue bureaucrats from removing (protecting) us from the power of choice. Which is the heart and soul of our liberties!

  263. Bio identical hormones have been used, with success, for many many years.
    I’ve been using them for a decade with no problems.

  264. My husband and I both use bio identical hormones prescribed by our Functional doctor after reviewing our lab test and our symptoms. I ask that the members of NASEM, the FDA, and Congress seriously study this issue. After reading all of the positive benefits that they do WHAT IS BEST for women and men who are very successfully using cBHRT which provide a solution for their symptoms. In our case, other medications prescribed by our PCP did not help so we turned to the Functional doctor! We are very happy with our cBHRT. I do not understand why the members of these committees would even consider adding these hormones to the Demonstrably Difficult to Compound List unless they are being pressured by the pharmaceutical companies!

  265. Please keep these bio identical hormones available to women and men. Our bodies are all unique and we need medication made for our individual needs!

  266. Bioidentical hormones are very important to women of all ages. They must remain legally available!

  267. The FDA needs to read the studies done in Europe and in U. S. That show no harm comes from these Bhrt These compounded hormones only help people live a normal and productive life We don’t have to worry about cancer or other serious side effects. Doctors who prescribe bhrt monitor blood levels this makes it doubly safe. We need to keep our natural hormones. It should be our garunteed right.

  268. Please keep these bioidentical hormones available to those who need them. To some it is the difference between pain and a normal life.

  269. I’m sorry to hear that there is a controversy over bio-identical hormones at all! I have used them for 16 years with NO adverse factors which is remarkably different from any pharmaceutical options. In a time when marijuana products are sold with little medical oversight, I am amazed compounding pharmacy products are scrutinized. I have never heard of someone in a medical crisis as a result of being prescribed bio-identical hormones produced by a reputable compounding pharmacy.
    I remember the first time I took bio-identical hormones. Within twelve hours I was fully functional after more than a year of never having slept more than four hours at a time. Apparently, I’m the poster child for this one!

  270. I have been on Biest since menopause for bone loss…..I do not want fosomax and one of those that can ruin your digestive tract, but that seems to be the other choice i have been offered….

  271. NASEM, FDA and Congress must hear all the evidence from Prescribers and Compounding Pharmacists.
    It seem to me that minds are already made up…..you do not want to hear the evidence. The evidence is clear. Bio-Identical Hormones and Glandulars work and I have done my own research on both, I use both.
    13 years ago My doctor missed one number on my bloodwork and that was my TSH. It was at 8 I had gained 25 lbs and I was at that time 5ft 1in and 138 lbs. I had to search out a doctor that would prescribe me Armour Thyroid. I found one and I was also prescribed Bio-Identical Hormones. What a difference they have both made in my life. My thyroid has been stable for the last 12 years and my tremendous night sweats and hot flashes are gone, dry skin and mental state have been much better.
    I will not be without my hormones or my glandular and will do what I need to do to get them. This is very important to me and millions of men and women.
    I demand that NASEM give a fair and proper hearing to the experts on cBHRT.

  272. DON’T THE PHARMA COMPANIES MAKE ENOUGH MONEY !!!! THE FDA SHOULDN’T BE INTERFERING WITH THE RIGHTS OF PEOPLE WHO DON’T CHOOSE TO USE SYNTHETIC DRUGS WITH MANY UNTOWARD SIDE EFFECTS. IT IS IMPORTANT THAT THE BIO-IDENTICAL HORMONES AND OTHER COMPOUNDED DRUGS ARE AVAILABLE TO ALL WHO NEED THEM.

  273. I am a retired compounding pharmacist located in S. Carolina..When I sold my compounding pharmacy in 2017 I had been compounding Bioidentical hormones for over 20 years. I had over 6000 female patients and collaborated with over 300 prescribers on a regular basis.I also had hundreds of male patients..Synthetic hormones, which is the mainstay of most prescribers have a different chemical structure than BioIdentical hormones. BHRT has the identical chemical structure as the hormones produced by the human body..which is why the body readily responds to their introduction to the human body.The body welcomes BHRT while rejecting the synthetic manufactured hormones as “alien” to the body. It makes sense that the body would rather have the identical “key” rather than a reconstructured “key” made different so it can be patented..The only reason Big Pharma is not interested in BHRT is they cannot patent them.They are “free” in nature, therefore unpatentable..They must be changed slightly to be made patentable..This “change” makes synthetic estrogen dangerous. The body cannot recognize it as it does BHRT..Millions of women around the world depend on BHRT to give then wonderful quality of life while natural progesterone protects the female body from “the angel of life and death” ESTROGEN..All women receive this protection any month they ovulate (which is the source of natural progesterone). When they no longer can make their own progesterone and if FDA denies them supplemental progesterone then they find themselves alone with ESTROGEN..(the angel of death)..Estrogen makes female organ cells divide and grow,,Progesterone opposes that division and growth..Women NEED estrogen but they also NEED progesterone to protect them..All women lose that protection when they no longer “ovulate”, for what whatever reason..It would be a crime against female humanity to prevent them from accessing these wonderful, life saving BIOIDENTICAL hormones..For 20 years I witnessed daily the wonderful mental and physical benefits of BHRT therapy..Please Please FDA do not outlaw these wonderful hormones…my opinion..

  274. I have used BHRT for about 10 years. I can’t imagine what could be behind this FDA action to remove their use. It appears that’s once again Big Pharma is pulling the strings at the FDA. This is totally unacceptable that such a rigged process is being used to take genuine relief from millions of women.

  275. I’m 73 and have been taking bioidentical estradiol and progesterone for about 15 years. They have given me my life back! These maladies have all but disappeared: chronic insomnia, severe sleep apnea, TMJ headaches, virtually no sex drive, no vitality, osteopenia, unhealthy weight loss. Please continue to make these life-giving hormones available to me.

  276. I have been taking bioidentical hormones for several years. I am unable to take synthetic hormones as their side effects are unbearable. Without my bioidentical hormones feel physically and mentally unwell. It would make life unbearable to be without them. Please do the right thing which is to refuse to bow down the greedy pharmaceutical companies. These medications are direly needed by many people.

  277. I have been taking bio identical hormones for 25 years with wonderful results. They are carefully prescribed by my doctor to match my individual needs. Please do not change the system. Allow my doctor to keep ordering the exact hormones that I need!

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