Confronting the threat to compounded hormone therapy
One of APC’s biggest initiatives is our upcoming nationwide media campaign aimed at stopping the FDA’s threat to restrict compounded bioidentical hormone therapy — treatment that has done wonders for millions of women and men for decades.
That threat to cBHT is not only a threat to patients, but to pharmacies as well, with cBHT one of the most frequently compounded medications. APC and the coalition we’re building are stepping up to counter this threat — and whatever comes next.
The FDA, no fan of compounding, commissioned a study from the National Academies of Sciences, Engineering, and Medicine on “the safety, effectiveness, and use” of compounded bioidentical hormone [replacement] therapy (cBHT or cBHRT). The study concluded that there isn’t much clinical evidence for or against cBHT. Strangely, though, the study recommended that cBHT be restricted.
Now, despite the undisputed fact that millions of Americans use cBHT every day and rely on it, the FDA is using that study — yes, the one it paid for — as an excuse to consider limiting or even outright banning compounded hormone therapy.
This cannot be allowed to happen. The lives and health of too many people are at risk.
APC is leading a coalition of cBHT compounders, prescribers, and patients to mount a digital media campaign aimed at confronting the threat to compounding hormone therapy. It’s a $1.5 million effort that launches Q2 2021.
Read an overview of that media campaign.
April 2021: Berkeley Research Group’s whitepaper analyzing the NASEM report (27-page PDF)
- Summary of that BRG analysis (2-page PDF)
- VIDEO (April 20, 2021): The analysis of the NASEM report by BRG, from the Pharmacy Compounding Foundation
March 2021: FOIA-requested documents provide unambiguous evidence of bias in NASEM report.
Tools you can use
Join the Cause: a four-page (PDF) brochure explaining the issue and urging people to contribute to the media campaign
Recruit your vendors: Here’s a sample letter (.docx format) you can customize and send your vendors, asking them to support the campaign to save cBHT.
Add prescribers’ voices: Here’s a sample letter for prescribers they can use to inform patients of the threat to cBHT.
Present the facts: a PowerPoint slide deck you can use in presentations for legislators, physicians, and even patients to explain the threat to cBHT
- NASEM’s overview of its recommendations (4-page PDF) and
the full NASEM cBHT report (350+page PDF).
- Joint Congressional letter to FDA Commissioner Stephen Hahn
- APC’s Statement on Release of NASEM’s cBHT ‘Study’
- VIDEO: APC February 25 Town Hall Briefing — campaign update
- VIDEO: APC October 25, 2020 Town Hall Briefing — campaign update
- VIDEO: APC December 4 Town Hall Meeting to announce campaign