Thousands of people in your state face a potential health crisis.
Based on a flawed report that it commissioned, the FDA is signaling that it may consider new restrictions on compounded hormones.
The consequences for your constituents could be severe.
Hear from the most affected
The need for compounded hormones is immense. The stories of the patients (and their physicians) who rely on compounded hormones make clear that access to this essential therapy must be protected.
In their own words
Explore our interactive map that demonstrates the importance of compounded medicines to patients all across the country. Filter these first-hand accounts by state to see just how vital compounded medicines are.
THE NEED FOR COMPOUNDED HORMONES IS IMMENSE
Hormones have been compounded for decades
The NASEM report recommends placing hormones on the "Demonstrably Difficult to Compound" list, which would prohibit most pharmacists from preparing hormone formulations.
Hormones have been prescribed by physicians, compounded by pharmacists and taken by patients for generations. Many patients have taken them for decades. And patient outcomes, measured over decades, are excellent. Hormones are not difficult to compound. Obviously.
The review that NASEM was expected but failed to do
While limited in scope, a new meta-analysis of patient outcomes reveals that compounded hormones provide real benefits to patients and also find that compounded hormones pose no increased risk compared to FDA-approved products.
As part of its commission, NASEM was to review the body of patient-outcome studies for compounded hormones. NASEM chose to ignore that data, instead selecting only 13 studies to include in its report, mostly featuring hormones that are not among the most commonly prescribed. (Studies that matched their predetermined outcome?)
This report, published in Menopause, the journal of the North American Menopause Society, is exactly the kind of unbiased research that NASEM should have done but didn't.
"...compounded hormones provide real benefits to patients and finds that compunded hormones pose no increased risk copared to FDA-approved products."
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The NASEM Report
The foundation of the FDA's action is deeply flawed
Physicians have been prescribing and patients have been taking compounded hormones for decades. The FDA-funded NASEM report (produced by the National Academics of Science, Engineering and Medicine) ignores most of data on successful patient outcomes. It excludes the insights of both physicians and pharmacists who have extensive, patient-facing cBHT experience. The NASEM Committee only included a fraction of the available data on the topic, which shows that their report does not reflect a complete or accurate understanding of compounded hormones.
Learn more about the Flaws behind the FDA's ActionsInvest today to protect access to compounded hormones.
When the FDA signaled that it might severely restrict access to compounded hormones, we launched a campaign to raise awareness among patients, doctors and, especially, members of Congress.
When you contribute to this campaign — you are protecting access to this life-changing therapy for millions of patients.
