ISSUES

What is the NASEM Study About Bioidentical Hormone Replacement Therapy?

In recent years, thousands of healthcare providers and millions of patients, both women and men, have turned to compounded medications to treat hormone-related health concerns. These products often are described as “bioidentical” and are commonly referred to as “Compounded Bioidentical Hormone Replacement Therapy” (cBHRT). Pharmacy compounding is a long-established tradition that allows a physician to prescribe a unique medication, prepared by a pharmacist, for a patient’s individual needs. Before massive pharmaceutical companies existed, compounded medications were the majority of prescription drugs.

The Food & Drug Administration (FDA) commissioned an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study to determine whether women and men need the option for prescribed cBHRT, or whether existing manufactured drugs made by large pharmaceutical companies can meet this need. In July 2020, NASEM issued the controversial report of its findings. (A NASEM press release provides a summary of the full report.)

FDA asked NASEM to “examine the clinical utility of treating patients with compounded cBHRT products.” Essentially, FDA wants to hide behind the recommendation of a supposedly independent scientific organization, as it seriously considers whether to severely limit or even take away the option that prescribers and patients currently have to use cBHRT.

The NASEM committee was composed of medical professionals with sterling credentials. However, none of the committee members had any clinical expertise or experience treating women or men with compounded hormones, and no expert compounding pharmacists were on the committee! The questions that committee members asked at meetings showed an alarming lack of knowledge about the topic they considered. 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 mass-marketed drug approvals. CBHRT is not designed for mass markets but for patient-specific individualized therapy. Also, cBHRT cannot be patented because it has the same molecular structure that exists in the human body. This type of information and so-called double-blind studies on compounded hormones, which are incredibly expensive to undertake, are simply not available and are not required for compounded medications.

In its request for the NASEM study, FDA said that “ cBHRT 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 stated its clear preference for “one-size-fits-all” drug company medications. This ignores the fact that compounded medications are made by pharmacies, which are licensed by state boards of pharmacy, not FDA. Entirely different standards are applied to manufactured drugs than to compounded medications.

All of this means that the NASEM committee was naturally biased towards hormones marketed by the large drug companies, with a one-size approach that has failed both men’s and women’s health needs.

From the start of the NASEM study, FDA officials were present at meetings, directing and overseeing the process of a supposedly independent study. This, coupled with the fact that the NASEM committee did not have any members with any experience in compounding or prescribing cBHRT, violates the Federal Advisory Committee Act (FACA). FACA requires that advisory committees like this have a balanced and representative make-up and that they operate independently of pressure or influence from the sponsoring agency.

The NASEM committee essentially determined that women and men don’t need compounded alternatives to drug-company hormones. As a result, this highly prejudiced and likely illegal study could become the basis for FDA moving to outlaw most if not all cBHRT.

That is why it is important to stop FDA’s assault on compounded hormones using the flawed and biased NASEM study as a rationale for this action.