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In recent years, an increasing number of health care providers and patients have turned to compounded drugs for the treatment of hormone-related health concerns. These products are often marketed as “bioidentical” or “natural” and are commonly referred to as compounded “Bioidentical Hormone Replacement Therapy” (cBHRT). These compounded preparations are often marketed as safer alternatives to the FDA-approved hormone products; however, the FDA does not review or approve compounded preparations for safety, quality, or effectiveness. As a result, FDA asked the National Academies to convene a consensus study to evaluate the safety, effectiveness, use, and overall clinical utility of cBHRT.
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Consensus
·2020
The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from h...
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Description
An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (National Academies) will conduct a study to assess the clinical utility of treating patients with compounded "bioidentical hormone replacement therapy" (BHRT) drug products.
The committee will:
- Review the current and historic use of compounded BHRT drug products to treat patients, including information about the medical condition(s) that these compounded drug products have been used to treat;
- Describe the physical and chemical characteristics of compounded BHRT drug products (e.g., active ingredient, inactive ingredient(s), dosage forms, routes of administration, strengths);
- Review and assess the available evidence (or lack of evidence) regarding the safety and effectiveness of compounded BHRT drug products;
- Summarize findings and make recommendations based on the available evidence with respect to
- the clinical utility of compounded BHRT drug products;
- whether the available evidence of safety and effectiveness supports use of compounded BHRT drug products to treat patients; and
- the patient populations that might need a compounded BHRT drug product in lieu of an FDA-approved drug product.
*NOTE: The statement of task was revised on November 15, 2018.
Collaborators
Committee
Chair
Vice Chair
Member
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Committee Membership Roster Comments
Please note that there has been a change in the committee membership with the resignation of Committee Chair Dr. Jerome Strauss, III effective 03/22/2019, and appointment of Dr. Donald R. Mattison as Chair on 03/28/2019 and Dr. Ruth M. Parker as Vice-Chair on 03/28/2019.
Sponsors
U.S. Food and Drug Administration
Staff
Andrew March
Claire Giammaria
Elizabeth Townsend
Justin Jones
Major units and sub-units
Health and Medicine Division
Lead
Board on Health Sciences Policy
Lead