On July 1, 2020, the National Academies of Science, Engineering, and Medicine (NASEM) in a study sponsored by the
Food and Drug Administration (FDA), released a report on the clinical utility of compounded bioidentical hormonal therapy (cBHT).
This report can be summarized in the following statements:
- “There is currently insufficient evidence to support the clinical utility of cBHT.”
- “Recommend that the FDA review 10 BHTs as candidates for the agency’s Difficult to Compound list, which prohibits pharmacies from compounding certain products. . .”
- “To address the public health concerns. . . increased federal and state-level oversight. . .”
If the FDA acts on the NASEM Report, it can shut down the entire cBHT enterprise.
The NASEM report calls for “stakeholders to develop a strategic plan to support precompetitive research projects and activities.” It also details the type of data they want to see, namely “collection of adverse even data”, “well-controlled trials. . .to examine effects on safety and symptoms” and data collection efforts “approved by an appropriate institutional review board, as well as informed consent from all patients and study participants.”
The way to protect cBHT is to collect the regulatory quality data wanted by the FDA.
THE TAPROOT MASTER
OBSERVATIONAL TRIAL SOLUTION
Taproot Health has designed the solution.
THE NATIONAL cBHT MOT
The planned cBHT Master Observational Trial (cBHT MOT) is protocol driven, IRB approved, prospective, multicenter, patient consented, adaptable observational trial in patients receiving hormone replacement. This allows any pharmacy, distributor, clinic, or patient, to participate in a precompetitive and streamlined data collection effort to demonstrate safety, effectiveness, and quality of life. Not only does Taproot’s cBHT MOT compliment other data collection efforts, but it also allows continual expansion of cBHT through a reusable data infrastructure.
CALL TO ACTION
We invite all stakeholders in the cBHT community to join Taproot’s Nation cBHT MOT to collect the data needed to address the safety and effectiveness of cBHT.
We need to come together to protect cBHT.
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