Bioidentical Hormones Threatened

Will the FDA allow massive drug companies to eliminate your access to compounded bioidentical hormones? Action Alerts!
Recently, the FDA released a list of nominations to its “Demonstrably Difficult to Compound” (DDC) list. This list derives from section 503A of the Food, Drug, and Cosmetic Act. It is supposed to identify drugs that cannot safely be compounded because of their complexity.
If the FDA approves these new nominations, your access to certain kinds of hormones that are biologically identical to the hormones in your body, such as progesterone (including progesterone with estradiol), human chorionic gonadotropin (HCG), testosterone, and estriol, could disappear. Drug companies would then have what they always want—a government-enforced monopoly—even though the pharmaceutical versions or their alternative products are often substandard or even dangerous.
We reached out to compounding pharmacists and asked them if these hormones were indeed difficult to compound, or if there had been any adverse events or customer complaints regarding the safety of the medications. The resounding answer was No, that these hormones did not present any particular difficulties to compound, and the only safety issues they were familiar with were allergic reactions from the delivery system—for example, if the preparation was contained in a topical cream, one might see an allergic reaction to the cream base. The pharmacists were not aware of any other significant safety issues to the compounded medicines themselves.
Access to these compounded drugs can be a life-and-death issue. Take estriol, for example—one of the three types of estrogen produced by the body. By the 1990s, one-third of menopausal women were taking Premarin, which comes from horse urine estrogens and is not bioidentical to human estrogen. Unfortunately:

  • Research showed that Premarin and other synthetic forms of estrogen were linked to a much higher risk of breast cancer, blood clotting, and heart disease.
  • A study published in the Journal of the American Medical Association showed that women who took Prempro—a combination of Premarin and synthetic progestin—were twice as likely to die from breast cancer.
  • Other evidence has shown that synthetic hormone replacement therapy is linked to an increased risk of stroke, with other possible side effects including osteoporosis, high blood pressure, vaginal bleeding, and weight gain.

Bioidentical estriol, on the other hand, not only appears to be safer, it has also been shown to improve bone density, promote youthful skin, and enhance urinary health. In short, limiting patient access to compounded estriol and other bioidentical, natural forms of hormones is a terrible idea.
Not only are these specific hormones being targeted, but the systems for delivering them are targeted as well. Also on the list of nominations to this list are bioidentical hormones in pellet form, dry powder inhalers, metered dose inhalers, transdermal delivery systems, and time-release dose forms. Even creams could be at risk, because big drug companies almost always sell hormones in tablet form, even though many hormones simply do not work this way, and must be taken as creams to be safely and effectively utilized by the body.
Compounded medicines are—by definition—meant to conform the very particular needs of the individual patient. If you have trouble taking pills, or require specialized doses, or need a gluten-free form of a medication, a pharmacist can meet your personal needs. It is this precisely customized medicine that seems to be coming under attack here, and it doesn’t take much imagination to guess where the attack is coming from.
Of the seventy-one total nominations, multinational Big Pharma giant and sixth-largest drug maker in the world, GlaxoSmithKline (GSK), nominated twenty-seven different medications for the list. It should come as no surprise to learn that many of these nominations represent competition for the top 100 best-selling branded drugs—one of which was in the top five drugs of all time. The only shock over GSK’s nominations was that they were identified as such!
Some of the other nominations may have also originated from major drug companies, but they were submitted in a stealthier manner. An initial review of the DDC list provides some clues:

  • The specific bioidentical hormones were nominated by three doctors. Wulf Utian, an independent consultant to the pharmaceutical and investment banking industries, nominated the oral and topical forms of estradiol, progesterone, and the combination of the two. Dr. Carolyn Quist, who runs a women’s health clinic, nominated estriol, despite the fact that she actually recommends compounded estriol creams in her practice. Dr. Kenneth Woliner, who runs what he describes as a holistic family medical practice, nominated the natural hormone HGC (human chorionic gonadotropin), even though he always prescribes bioidentical hormones for women needing hormone replacement therapy. When we contacted these doctors’ offices to ask why they made these nominations, none of their offices returned our calls. Do they really think they have some special knowledge of how difficult these drugs are to compound, despite their own prescribing history? Are they now doing the bidding of Big Pharma for some reason? We just don’t know.
  • Public Citizen, a Washington, DC-based nonprofit, was behind all of the nominations in the more general “complex dosage forms” category. We don’t think they have any connections to the pharmaceutical industry; it’s likely that they simply do not have the facts right about the dangers of these different forms of delivering compounded medicines, or else they are pursuing a different agenda.

What will happen now? Normal procedure would be for the FDA to review the list of nominations, respond with its own list, and give the public an opportunity to weigh in. But it appears that the FDA may deny the public any input. We sincerely hope the FDA will follow these rules, but experience has made us somewhat skeptical. Regular readers will remember that the FDA has viewed public involvement as an unnecessary roadblock as it adds items to the Withdrawn or Removed list—essentially eliminating certain compounded medicines from the market.
Three Action Alerts!

  1. Send a message to the FDA, asking the agency to follow the rules and issue a proposed rulemaking before finalizing its Demonstrably Difficult to Compound list. Also tell them how important the survival of these compounded drugs is for you.
  2. Send a message to the doctors who nominated bioidentical hormones to the DDC list, and urge them to rescind their nominations to protect patient access to important treatments.
  3. Send a message to drug giant GSK protesting their sneak attack on your medical choice, letting them know that they are further damaging their standing with the public.

Please send your messages immediately.


  1. It’s time to stock up now just in case, and to get people to start growing their own herbs for these purposes.

    1. What we need is 3D printing machines for bioidentical hormones so the whole government-enforced monopoly issue is moot. Can’t wait for that day!

  2. I am disgusted and yet not surprised. There is no limit to corporate greed. I will not take the drug companies’ hormones. So corporate greed has the potential of simply denying me quality of life since they will never gain me as a customer. I forwarded this onto my medical provider and hope that they distribute this to the entire patient list and many patients participate in this campaign. Yep, the great capitalist way…..

    1. Hi, to all i encourage all of you and friends and Doctors to
      google U.S Senate Committee on Health Education Labor &
      Pensions! This committee over sees the FDA, i guess they allow the FDA to make and create their own laws, with no
      accountability to no one. This is are best chance to have some of these Senators hold the FDA accountable and
      allow us citizens to choose what method of treatment is best
      for us, we are growing adults, educated, and informed! Bioidentical Hormones have been studied for over 40 years
      and have been proven to be safe. So please contact all of
      these Senators on this committee look up their offices and
      each one of them, you will get a assistant to the Senators and
      express your outrage of what the FDA is proposing to do
      with Bioidentical Hormones, and other Supplements. Here is
      a few names that are on this committee Bernie Sanders, Elizabeth Warren, Orrin Hatch,Al Franken just to name a few.
      their are 21members on this committee so i suggest to give
      all of them a call i’am today.

  3. A good friend has been getting his testosterone from a compounding pharmacy. We have to drive a LONG way to get it, too. But the cost is only about $150 for a month’s supply and it’s not covered on his Plan D. If he was not able to get it at this price he simply would not take it. His medication expense WITH Plan D insurance is about 1/2 of his disability. Add that to doctor and surgeon deductibles and he’s lucky to be able to eat. Many men his age would not be so fortunate, and the lack of this hormone can cause a lot of negative issues in older men.

  4. Unable to find email for Dr. Carolyn Quist; snail mail for office: 1425 8th Avenue, Fort Worth TX 76104.

  5. The politicians and their bureaucrat minions kill us to raise their campaign contibutions from Big Pharma. They can replace voters with immigrants so easily. A new crop to poison. We know better! Medicine from natural substances, not synthesized to be patentable, is much safer and works.

  6. I share all of your sentiments about this ongoing shameful violation of our freedom and medical right to choose. I have been using SottoPelle BHRT for 10 years and consider it the REAL health insurance coverage plan.

  7. Public Citizen is in DC, just like you are. I’d take the time to sit down with people from this group to educate them and I’d send doctors if you have them. I suspect they are relying on their understanding of the “rigors” of FDA. Take the time to educate them, because if you can convince them, it will do a lot of good.
    I was sorry to read about these other doctors, particularly those who prescribe bio-identical hormones. I wonder whether they were privately lobbied by colleagues with more direct connection to big pharma.

  8. Nothing to see here, move along. Just another illustration of the FDA being used to enhance a monopoly. The 800lb Gorilla is that label saying “Federal law prohibits…” meaning that if an all-mighty MD didn’t prescribe it, you can’t have it. The major beneficiary of this is the AMA which no longer has to worry about competition. See also the changes to the Health Savings Accounts which now requires a prescription for just about everything and you will understand why the AMA signed on to Obamacare. Note, in this case, that Doctors are part of the cabal to kill off compounders.

  9. I have contacted Dr. Woliner’s office. He is specifically against the HCG diet scam, as per his secretary. He often prescribes bioidentical hormones to his patients. Since there is confusion about where these doctors actually stand, I am not going to send any more communications based on this article. We know the FDA is interested in limiting our access to compounded options, but these doctors may or may not be against bioidentical hormones, in general.

  10. Big Pharma prefers the use of a drug made from mare’s urine. It’s a cruel industry, not to mention that Premarin has been known to cause breast cancer

  11. Basic research has shown bioidentical hormones are safe while medical HRT is dangerous. Bioidentical hormones don’t carry drug company patents/protection. The FDA works for the drug companies, not the people of the USA.

  12. My GYN didn’t want me to take synthetic hormones so I used Progest Cream instead. It worked beautifully. After 2 weeks of use all my numerous hot flashes stopped and stayed that way as long as I used the cream and it had no unwanted side effects. It got me through a few years of menopause and I highly recommend it.

  13. On the simplest level if GSK wants it, you certainly don’t. 99 out of 100 times, if the FDA rules on it, those rules will not serve you. Its that simple.

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