FDA Turns Its Back on Women with Menopause

June 21, 2018

Help us get Congress to step in and tell the agency to knock it off. Action Alert!

What if we were to tell you that there was a treatment for the effects of menopause that:

Sounds like a good deal, right? That treatment is estriol, one of the three main forms of estrogen produced by the body. With their safety profile and health benefits, it isn’t surprising that one third of women who use hormone therapy choose estriol and other safe, effective, and natural bioidentical hormones to manage the symptoms of menopause. Unfortunately, the FDA is poised to remove access to these hormones and to leave ailing women with no other option but more dangerous alternatives. ANH-USA is leading the charge to protect these crucial hormones, but we need your help to enlist members of Congress to get the FDA to back off.

Here’s what’s happened. In 2013 Congress passed a law to update the regulation of compounding pharmacies, which make customized medications for individual patients, including bioidentical hormones treatments. The FDA has made ample use of this opportunity to restrict or eliminate access to natural medicines, including bioidentical hormones.

The latest attack has been launched by nominating bioidentical hormones to the Difficult to Compound List. The FDA is in the process of reviewing the nominations; when finalized, items on this list cannot be compounded. In normal circumstances—and perhaps if the agency wasn’t beholden to pharmaceutical interests—mere nomination wouldn’t be such a cause for concern. But the track record thus far does not inspire optimism. In a related process where the FDA and its advisory committee are reviewing which substances can be compounded, the committee, following the FDA’s guidance, has voted to ban a number of demonstrably safe ingredients, such as curcumin, MSM (methylsulfonylmethane), boswelia, and aloe vera.

Bioidentical hormones including progesterone, progesterone with estradiol, and estriol have all been nominated to the Difficult to Compound List. Since there is no FDA-approved estriol product, placement on the Difficult to Compound List means that consumers will lose access to estriol altogether.

Given that customized, bioidentical hormones are safe, effective, and not difficult to compound, why is this happening? Unfortunately, the FDA appears to be working at the behest of drug manufacturers whose products compete with these compounded hormones.

Note that this isn’t the first time the FDA has targeted bioidentical hormones. In 2008, the FDA – likely acting upon a petition it received from Wyeth Pharmaceuticals, the manufacturer of Premarin (an estrogen drug made from pregnant horse mares’ urine) – went after bioidentical hormones, particularly estriol. Thanks to ANH members and the wider natural health community, the FDA backed off. Now, the FDA sees an opportunity to remove estriol and other hormones by other means and we must once again mobilize to stop them.

The FDA’s hostility towards bioidentical hormones is even more ridiculous when we consider that they are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”

ANH-USA is working with Congressman Mark Pocan (D-WI) to circulate a sign-on letter to members of Congress, urging the FDA not to consider bioidentical hormones for the Difficult to Compound list, and ensure that the millions of women who rely on these treatments to stay healthy can continue to access them. ANH is also working to start a similar letter in the Senate. We must make this an issue that Congress cannot ignore.

Action Alert! Write to your member of Congress and urge him or her to sign on to Rep. Pocan’s letter to protect bioidentical hormones; write to your senators and urge them to circulate a similar letter in the Senate too. Please send your message immediately.


Donate! Support ANH’s educational and legal work to protect these life-saving compounded medications! Every dollar raised for this campaign will build our war chest to defend estriol and other compounded medicines from this and future threats!

6 responses to “FDA Turns Its Back on Women with Menopause”

  1. Anna Hale says:

    There was a time when I needed estriol and I don’t know what I would have done without it.

  2. locoadele says:

    I have known for decades that our health care system is oriented toward men, and that research on and for medical issues that affect primarily women is secondary. And research on issues that affect both sexes concentrates mainly on male sufferers. Heart disease studies had been done for decades primarily on men, even though causes, symptoms and effective treatments differ for women. And the unholy attack on reproductive health care for women is the icing on the sexist cake.

    • Dave Garry says:

      I have known for decades that our legal system is oriented toward women, and the horrible laws when it comes to divorce, alimony and child custody overwhelmingly benefit women. And consideration of any issues that primarily affect men are secondary. And the unholy attack on masculinity is the icing on the sexist cake.

      • locoadele says:

        What do you consider an “unholy attack on masculinity”? Do you resent the fact that women no longer need to submit to “superior” men; that they assert their rights as human beings? Does it bother you that you and your brothers no longer occupy your artificially exalted position? Maybe the legal system gave advantages to women in divorce, alimony and child custody cases was a way of compensating them for the indignities and inequalities suffered during marriage. And you should have noticed that the legal system has changed, and is treating men and women with more equality in those cases, reflecting their increased equal status when married. This is the 21st century, not the 1st. Deal with it!

        • Dave Garry says:

          How about the media portrayal of fathers? They are now ALWAYS portrayed as bumbling, inept fools, while the wives are portrayed as calm, cool, and leaders. Throw in 3rd wave feminism, cultural Marxism, how that is all pushed everywhere,…you can’t even approach a woman for a date these days without being labeled a creep….hell no the laws do not favor men at all and are nowhere equal… they allow divorce rape, cater to women’s hypergamous nature, and a woman has to practically be a provable life-long heroin junike or she will always get the kids..,and the welfare state has replaced the male figure in the home. throw in BPA and other endocrine disruptors in the food supply that lower testosterone. There is a HUGE assault on masculinity. This can’t be turned around overnight after nearly 50 years of this crap, but I shudder to think what this country would be like if Hillary was elected.

          • Keely Stahl says:

            That has absolutely NOTHING to do with how the health care system treats women vs men. (Prime example: viagra.) Your personal prejudices and emotions are getting the best of you.

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