We are facing a serious and unnecessary health crisis
Based on a flawed report that it commissioned, the FDA is signaling that it may severely restrict compounded hormones.
This could be a serious health crisis for millions of people.
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 compounded hormones pose no increased risk compared to FDA-approved products."
Patients, Doctors and Pharmacists
Tell your story. Talk to your representatives in Congress. Talk to your doctor. Talk to your friends.
Congress has oversight of the FDA. We need to make our voices heard in Congress before the FDA takes ill-conceived action that deprives millions of people of the critical therapy they need to live normally. We need you to join this cause; together we need to fight to protect compounded hormones.
Members of Congress, staffers, policy experts
While limited in scope, a new meta-study of patient outcomes shows that compounded hormones provide patients real benefit with no more risk than FDA-approved therapies.
This meta-study, published by the journal Menopause, is the scientific research that NASEM should have done, but failed to do. Yes, more studies of patient outcomes are vital, but this important study contrasts sharply with claims in the NASEM report.
If the FDA uses its (demonstrably) flawed NASEM study to put compounded hormones on the "Demonstrably Difficult to Compound" list, it will deny thousands of people in your state access to a vital medical therapy. Hormones have been compounded for decades, and patient-outcomes research shows that they provide lasting benefits to patients.
Understand this important issue before it profoundly impacts people's lives.
Is CBHT a vital therapy? Ask a physician.
The loss of compounded hormones as a treatment option for hormonal imbalance is a major health issue that will significantly affect physicians’ and pharmacists’ ability to treat their patients. It will deny physicians a critical option for patients who, for whatever reason, cannot take FDA-approved drugs.
Hear from one group of physicians, in their own words.
Invest 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.
