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FDA Getting Ready to Ban Hormones?

FDA Getting Ready to Ban Hormones?
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A new rule is in the pipeline that could spell the end of your access to compounded bioidentical hormones…unless we stop it. Action Alert!

Are you one of the millions of women who rely on compounded bioidentical hormone replacement therapy (cBHRT) to feel healthy and vibrant? Your ability to use compounded hormones is in serious jeopardy due to FDA paternalism. Help us fight back and protect your access to cBHRT!

For years now, we’ve been closely following the FDA’s attacks on pharmacy compounding. These are specialized pharmacies that make custom, individualized medicines for patients with specific needs. The FDA has been threatening to ban compounded bioidentical hormones like estriol, estradiol, progesterone, and testosterone for some time. That threat looks like it was the warm-up for what’s to come. We’ve just learned that the FDA is working on a rule that could be the death knell for compounded hormones. We now need to really ramp up pressure on Congress to stop the FDA’s attack on cBHRT.

To be clear: we do not know what is in the proposed rule yet, as it hasn’t been released—all that is publicly available is a vague summary. The rule will establish the criteria the FDA will use to place substances on the “Difficult to Compound” list (items that appear on this list will be banned from pharmacy compounding); the summary also states that the FDA may propose certain categories of drug products to include on the list. Remember that estriol, progesterone, testosterone, and estradiol have all been nominated to the “Difficult to Compound” list, making this proposed rule especially alarming.

It’s possible that compounded bioidentical hormones will not be included in the rule; the law states that the FDA has to consult its Pharmacy Compounding Advisory Committee (PCAC) before adding items to the Difficult to Compound list, and PCAC has not reviewed bioidentical hormones yet. But even if hormones are not banned in this particular rule, this news shows that the Difficult to Compound list is on the agency’s agenda. For compounded bioidentical hormones, it’s not a question of “if, but of “when” the FDA is going to drop the hammer.

The story of how we got here demonstrates the FDA’s hostility towards cBHRT. When several bioidentical hormones were nominated to the “Difficult to Compound” list years ago, ANH-USA and other stakeholders pushed back forcefully. This eventually led the FDA to convene a National Academies of Sciences, Engineering, and Medicine (NASEM) committee to study compounded hormones and aid in the agency’s process. In our view, the FDA did this because they wanted to ban hormones but knew they couldn’t do it quietly due to the large consumer response, so they commissioned NASEM to study the matter and give them cover.

As we reported previously, the NASEM committee’s report on cBHRT was anything but fair and impartial. In fact, the FDA was heavily involved in the development NASEM’s final report, all but guaranteeing that it reached the “proper” conclusions. The point is, it has been very apparent throughout this entire process that the FDA has it in for cBHRT, which adds to our deep concerns over this upcoming rule.

The FDA and NASEM are conscious that many, many women prefer compounded hormones to conventional hormone replacement therapy—they simply don’t care. A recent story in The Washington Post about a patient’s experience with bioidentical testosterone illustrates the positive experiences patients can have with these medicines. Oprah Winfrey once said, “After one day on bioidentical estrogen, I felt the veil lift.” This sentiment has been echoed by many other women who feel transformed after using compounded bioidentical hormones. It is callous and insultingly paternalistic for the FDA to restrict women’s ability to choose these medicines.

Congress is starting to take notice of the FDA’s senseless war against cBHRT. A letter being circulated in the Senate by US Senators Tammy Baldwin (D-WI) and Roger Marshall (R-KS) urges the FDA to enact policies that allow patients to continue using compounded bioidentical hormone replacement therapy (cBHRT). Earlier this year we supported a House of Representatives letter led by Representatives Jennifer Wexton (D-VA) and Michael Burgess (R-TX). Thanks to your help, ANH and other stakeholders were able to get 23 other Representatives to sign on to the letter, signaling their support for cBHRT. 

We must support any and all efforts to stop the FDA’s plans against cBHRT from moving forward.

Action Alert! Write to your Senators and tell them to sign on to the Senate letter headed by Sens. Baldwin and Marshall supporting consumer access to cBHRT. Please send your message immediately.

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