Have you benefited from Compounded Bioidentical Hormone Replacement Therapy (cBHRT)? If so, you won’t be happy with what the FDA is planning.
The FDA has never been a fan of pharmacy compounding, but now it is making a move that could keep millions of people like you from using this critical therapy.
Here’s the deal:
Last year, the agency commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study of cBHRT. The study ignored vast amounts of clinical evidence of its current effective use. But not surprising, NASEM recommended that cBHRT be severely restricted—which is exactly what the FDA paid it to say. The NASEM committee was composed of medical professionals with sterling credentials. However, none of the committee members has any clinical expertise or experience treating women or men with compounded hormones, and no experts on compounding were on the committee!
Never mind that tens of thousands of providers prescribe, and millions of Americans use cBHRT every day and rely on it. Never mind that the study didn’t find any significant negative effects cBHRT. Oh, and never mind that the NASEM study didn’t even ask the basic question: Does cBHRT work for patients? (It does. Very well.)
The FDA is using that study—yes, the one it paid for—as an excuse to consider limiting compounded hormone therapy by adding the entire class of medication to its so-called “too-difficult-to-compound list. Under federal law, the FDA does have the authority to place individual medications but not entire classes of drugs to this list. And there must be clear evidence of safety issues.
You read that right: If you use cBHRT, these medications may no longer be available to you.
A bi-partisan group of members of the U.S. House of Representatives, Mark Pocan (D-WI), Jaime Herrera-Beutler (R-WA), Henry Cuellar (D-TX), and Phil Roe (R-TN) have written a letter to the FDA commissioner, asking that the agency not limit cBHRT.
You can help cBHRT by asking your member of Congress to sign this letter!
We’ve made it easy for you.
https://www.savemycompounds.com/take-action/? Go here to take action.
We’ll match you with your House Representative and Senators and provide pre-written messages that you can customize. (If your Representative is a sponsor of the letter, you’ll be thanking him or her for doing so!) Please act right now.