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.

REGISTER NOW

By ANH-USA

What We Believe and What We Do

The Alliance for Natural Health USA (ANH-USA) is committed to sustainable health, the recognition that true health requires a proactive and preventive approach that focuses on a nutrient-rich diet, proper supplementation, and limiting our exposure to toxic substances. A system that is single-mindedly focused on “treating” sick people with expensive drugs, rather than maintaining healthy people, is neither practical nor economically sustainable.

ANH-USA is part of an international organization dedicated to promoting natural and sustainable health—and, in particular, consumer freedom of choice in healthcare—through good science and good law:

  • Since our founding in 1992, we have worked to shift the conventional medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an integrative approach incorporating functional foods, dietary supplements, and lifestyle changes. We believe this is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.
  • Sustainable health also applies the environmental ethic of conservation to our bodies. It urges us to live as nature intended us to live. Diet, nutritional supplements, exercise, and the avoidance of toxins are especially important tools in building and maintaining health.
  • Sustainable health is also about financial sustainability. Ever higher healthcare costs lead directly to higher unemployment and lower standards of living, both of which lead to more illness.
  • Today, preventive medicine is too often defined as taking more and more drugs at an earlier and earlier age, even in childhood. The concept of sustainable health is real preventive medicine and will dramatically reduce healthcare costs.

To this end, ANH-USA actively engages in legal initiatives, standing against forces that would limit your access to safe and effective dietary supplements, complementary therapies, and integrative medicines. We lobby Congress and state legislatures, act as a government watchdog, file comments on proposed rulemakings, and educate the public, the media, and other decision-makers.

Our most important tools:

  • A strong grassroots member base that is ready to act on a minute’s notice. ANH-USA is fortunate to have a dynamic, fast growing member base that collectively presents a unified front and demands their collective voice be heard. Thank you, members!
  • Effective lobbying. ANH-USA monitors legislation and regulatory activity on the state, federal, and international levels daily. Staying apprised of the domestic and global pulse on integrative medicine assists greatly in developing policy to advance integrative medicine.
  • Litigation. The court system has a role in protecting integrative medicine and a consumers’ right to choose. When it is required, ANH intervenes, through legal action, to protect the rights of the public.
  • Strategic coalitions. Collaboration is the most effective means to further a cause. ANH-USA has been highly effective in building long-term relationships with outside groups, members on the Hill, medical societies, and consumers from all walks of life.
  • Timely education campaigns. The timely launch of public educational campaigns is key to increasing support and recognition of key issues while furthering our overall cause.

Working closely with the media. Media can be a friend or a foe and whichever it may be, media is imperative to quickly disseminate a message. ANH-USA works collaboratively with the media to increase coverage of important natural health-related issues.

(Source: anh-usa.org; November 7, 2019; https://tinyurl.com/uxblasz)
Back to INF

Loading please wait...