CBHRT Coalition

Soon we can lose total access to Compounded Bioidentical Hormone Replenishment Therapy (cBHRT)

As we look over the tools available to us, are there any more important than compounded bioidentical hormones? Imagine the day you would have to tell your patients that you can no longer prescribe these hormones to them. Imagine the impact on their lives, relationships, on careers, and to the health of our population as a whole. Devastating.
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.)

Brief recent history:

  • In July 2020 NASEM published conclusions of their Committee on the Safety and Efficacy of Compounded Bioidentical Hormones. The core of this report comes down to their recommendations to the FDA.

  • The FDA had tasked, funded, and had a significant role in the proceedings of the Committee. Upon the release of the Committee report, the FDA immediately published their intentions.

  • NASEM suggestions boil down to:

    • “Restrict the use of compounded bioidentical hormone therapy preparations… to the following situations:
      – documented allergy to an active pharmaceutical ingredient or excipient of an FDA-approved drug product, or a documented requirement for a different dosage form …”

      This regulation directly has the FDA determining how a healthcare professional should practice medicine. This overreach goes beyond the mandate and authority of the FDA and like violations have been successfully challenged in the past.

    • “Patient preference alone should not determine the use of bioidentical preparations.”…This overreaches into the freedom of women and men patients to freely and privately choose their healthcare providers and, according to the modes of therapies and expertise offered.

    • “Review select bioidentical hormone therapies and dosage forms as candidates for the U.S FDA Difficult to Compound List, [including]: estradiol, estrone, estradiol cypionate, estriol, pregnenolone, dehydroepiandrosterone (DHEA) progesterone, testosterone, testosterone cypionate, and testosterone propionate…”

      This recommendation is potentially devastating to providers and patients. No drug can be compounded, if it is on the “Too Difficult to Compound List.” 13 If these bioidentical products are put on this list, that would be the immediate end of all compounded bioidentical hormone therapy.

      This regulation would destroy the present ability of physicians and patients even to access compounded bioidentical hormone treatments, at all. Such undue limitation will impact millions of patients (both women and men) who are living fulfilling, productive lives, thanks to these currently legal bioidentical hormone treatments.