It’s Time to Stand Up for cBHT Patients & Protect Quality of Life
As many of us are aware, the FDA is starting to make attempts to prohibit patient access to Compounded Bioidentical Hormone Therapy (cBHT). These would affect thousands of prescribers who rely on compounded therapies to help treat their patients, not to mention the millions of patients who want to be on custom therapies to help treat their conditions and overall wellbeing.
WHAT YOU SHOULD KNOW
You might be wondering why and how this is happening? I’d like to share with you what can be done to protect patient access to cBHT.
Why Does FDA Want to Restrict Patient Access to Compounded Therapies?
The FDA has always wanted every drug to go through the drug approval process. And if there’s an FDA-approved drug to treat a condition, the FDA wants prescribers to use those drugs first, regardless of the nature or origin of the drug.
How Are They Going About Removing Access?
FDA hired what was supposed to be a nonpartisan organization, the National Academies of Sciences, Engineering, and Medicine (NASEM), to conduct a review on the safety and efficacy of compounded hormone therapies. However, FDA exerted so much influence on NASEM’s compounded hormones report that not only is that Report essentially worthless, the process itself likely violated federal law. That’s what attorneys for a coalition of compounding pharmacies have discovered as a result of a Freedom of Information Act (FOIA) request of the FDA and NASEM. The coalition this week filed a 291-page supplement to its original public comment to FDA on the Report, concluding that “FDA cannot, in any way, adopt or rely on any of the conclusions or recommendations published by NASEM in its Report.”
This is a HUGE Problem
As Reed Smith attorney Rachael Pontikes explained in her supplemental comment letter, it appears that FDA merely wanted to use the trusted NASEM’ brand’ to promote its prejudiced opinions. “Regardless of FDA’s true intentions with this study, there is absolutely no way that the report can be considered independent of FDA’s management and control.”
Her conclusion is worth reading in its entirety: [W]e have seen enough to conclude that it is abundantly clear that FDA had actual management and control over the NASEM Committee, which made it impossible for the NASEM Committee to publish an independent, unbiased Report. Therefore, FDA must disregard this Report in its entirety—FDA cannot adopt any of the conclusions or recommendations in the NASEM Report because FDA’s interference with the Report violated FACA [the Federal Advisory Committee Act].
[…]FDA must reject the NASEM Committee’s Report and all the conclusions and recommendations therein, in favor of keeping cBHRT, a critical, life-saving therapy, available for the millions of patients that rely on this therapy.
Read the supplement letter (9-page PDF)
Get the entire supplement with all the exhibits (291-page PDF)
Together, We Can Protect Patient-Access & Quality of Life!
Support the Cause By Telling Your Story
Tell the FDA how compounded hormones help you and your patients. Feel free to share this link with your patients and on your social media platforms. The more voices band together on this issue, the louder we are heard!
Also, in conjunction with our compounding pharmacy trade organization, the Alliance for Pharmacy Compounding (APC), we are asking you, a healthcare professional, to help protect patient access to compounded therapies!
APC’s Media Campaign Fund is a three-year, consumer- and policymaker-focused initiative aimed at confronting FDA’s threat to restrict compounded hormones and at communicating the profound good pharmacy compounding plays in the lives of millions of patients. The campaign puts a patient face on compounding. Its tagline is ‘Compounding the joy of living – one patient at a time.’ The effort funded by gifts from pharmacy compounders, prescribers, patients, related organizations, and service and supply vendors in the compounding space.
Make a Donation Today to Protect Patient Access
we need to raise $1,000,000 to fund the media campaign for 2021. Visit the APC contribution page by May 30, 2021 to make a donation.
The default investment is $2,500, but you may change the dollar amount by clicking in the field to your desired investment amount.
Think about the threat to your business, and choose which option you prefer – a one-time gift for the start-up or an ongoing gift for the duration three-year campaign – so that we can beat back this threat to cBHT and your compounding practice.
This isn’t the first time patient access to medication has been threatened, and it will not be the last. We have and always will continue to fight for our patients’ medication choices and rights.
Yours In Health,
Shawn Hodges, PharmD
President & CEO, Innovation Compounding, Inc.
If you have any questions or would like additional information about the pharmacy, please contact us Monday-Friday, 9 a.m. to 5 p.m. EST, excluding all major holidays.