The Food & Drug Administration (FDA) has contracted with the National Academy of Science, Engineering and Medicine (NASEM) to determine whether women need the option of compounded bioidentical hormone replacement therapy (BHRT), or whether existing manufactured drugs made by the large drug companies can meet this need. FDA’s description of the study can be found here and the NASEM description to the study can be found here. NASEM has created an “ad hoc” committee that is conducting this study.
FDA is asking NASEM to “examine the clinical utility of treating patients with compounded BHT products.” In other words, FDA wants to decide whether women should even have the option of compounded BHRT. FDA wants to hide behind the recommendation of a scientific organization and could then move to take away the option prescribers and patients currently have to use compounded bioidentical hormones.
The ad hoc NASEM committee is composed of medical professionals with sterling credentials. However, none have clinical expertise and extensive experience with treating women with compounded hormones. The questions that many of the committee members have asked at meetings show an alarming lack of knowledge of the topic they are considering. And while NASEM is a well-respected organization, its committees are most familiar with the type of scientific and research information provided by drug companies that spend hundreds of millions of dollars for drug approvals. And since compounded bioidentical hormones cannot be patented as they have the same molecule as exists in the human body, this type of information and double-blind studies are simply not available.
In its request for the NASEM study, FDA states that “compounded BHT products are not FDA-approved, which means these products have not undergone an FDA assessment of safety, effectiveness and quality.” So, from the start, FDA states its clear preference for the “one size fits all” drug company medications.
All of this means that the NASEM committee will be naturally biased towards hormones marketed by the large drug companies, with a one-size approach that has failed women’s health. And if they determine that women don’t need compounded alternatives to drug-company hormones, it will be the basis for FDA moving to outlaw most if not all compounded BHRT.