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Hormones: The Fight Continues

Hormones: The Fight Continues
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Help us defend bioidentical hormone replacement therapy from an FDA ban. Action Alert!

We at ANH-USA have been keeping a close watch over the FDA’s ongoing process to regulate customized, natural medicines made at compounding pharmacies. Time and time again throughout this process, we’ve seen the FDA ban safe, natural ingredients from being used in compounded medicines that patients rely on—and soon bioidentical hormones like estriol, progesterone, and testosterone may be added to the list. It is up to us to defend these important medicines from FDA intrusion.

As you may recall, 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.

It will shock no one that the FDA appears biased against compounded bioidentical hormone replacement therapy (BHRT), as they compete with FDA-approved hormones made by pharmaceutical companies. The efforts of ANH members and the natural health community, however, produced a qualified victory: due to the overwhelming response from patients urging the FDA not to ban compounded BHRT, the FDA asked the National Academies of Science, Engineering, and Medicine (NASEM) to evaluate the “clinical utility” of compounded BHRT. We think the real goal of the NASEM study is to give the FDA cover when they eventually ban these hormones, but it is at least a sign that the FDA is not immune to pressure from the natural health community.

NASEM has conducted several public meetings to date on compounded BHRT. 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 compounded BHRT is used to treat menopause, meaning that committee members are susceptible to the FDA’s bias.

During one of the meetings, however, Dr. Rosensweet, a BHRT expert and advocate, was allowed to present—for just five minutes. Even in such a short time, Dr. Rosensweet was able to turn the tide and offer compelling evidence for compounded BHRT.

We must use every tool at our disposal to protect compounded hormones, which means getting Dr. Rosensweet more time and opportunities to present to the FDA and NASEM. Approximately 2.5 million women rely on compounded BHRT annually; we cannot allow the FDA to plow forward unchecked with a ban on compounded hormones. (You can read our previous coverage to see why so many women choose compounded BHRT over FDA-approved drugs.)

Action Alert! Write to the FDA and NASEM, asking them to allow Dr. Rosensweet more time to present the case for compounded BHRT to counterbalance the FDA’s biased narrative. Please send your message immediately.

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