cBHT Coalition emerges in wake of NASEM report
Compounders and prescribers of cBHT are organizing in the wake of the recently released NASEM study of compounded Bioidentical Hormone Therapy, released July 1. A loose coalition convened by Dr. Daved Rosensweet has begun to develop strategies and tactics aimed at demonstrating to FDA and others the clear safety and effectiveness of cBHT. APC’s CEO Scott Brunner, CAE, is co-chairing the coalition with Dr. Rosensweet, and several APC members are serving on committees the coalition has formed.
“The NASEM study was flawed in numerous ways,” said APC President Shawn Hodges, “APC made that case in its public statement after it was released. But because its findings support FDA’s longstanding opposition to cBHT, it’s likely to be influential in FDA’s anticipated attempts to prohibit or curtail cBHT. We must confront the errors of that NASEM report with solid peer-reviewed research and patient outcomes data. We’ll need to make that case to FDA, to members of Congress, and to the media if we want to preserve cBHT as a viable therapy for millions of Americans. That’s why it’s important for APC and its members to engage with patients and prescribers in this emerging coalition. We’ll have a much greater chance of success together than separately.”
Here’s the plan for the coalition, and what it’s trying to achieve:
First and foremost, the coalition is dedicated to demonstrating the safety and effectiveness of compounded bioidentical hormone therapy and preserving its place as a treatment option for millions of Americans.
It will do that through a combination of advocacy, communications, and presentation of compelling scientific data. The goal: a regulatory framework in which cBHT remains a viable, accessible treatment option for patients.
The outcomes its working toward:
- ACCESS: That timely, affordable, quality-assured cBHT therapy is available to and accessible by patients.
- ADVOCACY: That state and federal regulation recognizes and supports the safety and effectiveness of cBHT in treating patients.
- EXPERTISE: That both prescribers and pharmacy compounders have the knowledge and expertise to treat patients with cBHT.
- PERCEPTION: Healthcare consumers and the professional medical community generally recognize cBHT as a safe and effective treatment option.
The coalition committee will begin meeting soon, and we would love to have you join. You can volunteer here to serve on a cBHT Coalition committee.
Stay tuned for updates and likely calls-to-action as the coalition ramps up.