CALL TO ACTION: Stop the FDA from restricting compounded hormone therapy!

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Nelson Vergel

Founder, ExcelMale.com
Have you benefited from compounded hormone therapy?

If so, you won't be happy with what the FDA is planning.


The FDA has never been a fan of pharmacy compounding, but now it looks to be making a move that could keep millions of people from using a critical therapy.

Here's the deal:

Last year, the agency paid the National Academies of Science, Engineering, & Medicine to do a study of compounded hormone therapy (cBHT). The study concluded that there isn't much
clinical evidence for or against its use. But then NASEM recommended that cBHT be restricted — which is exactly what the FDA wanted it to say.

Never mind that millions of Americans use cBHT every day and rely on it. Never mind that the study didn't find any significant negative effects of cBHT. Oh, and never mind that the
NASEM study didn't even ask the basic question: Does cBHT work for patients? (It does. Very well.)

And now:

The FDA is using that study — yes, the one it paid for — as an excuse to consider limiting compounded hormone therapy.

You read that right:
If you or someone you know uses cBHT, it might not be available any more.

Luckily, members of the U.S. House of Representatives have written a joint letter to the FDA commissioner, asking that the agency not limit compounded hormone therapy.
You can help protect hormone therapy by asking your member of Congress to sign
these letters!

Ask your U.S. House member to sign the joint letter to FDA sponsored by Reps. Pocan, Herrera-Beutler, Cuellar, and Roe.

We’ve made it easy for you: Click the box below, and you’ll find a pre-written message — feel free to customize it — to send to your elected officials. Takes less than two minutes
to do it.

 
Defy Medical TRT clinic doctor

klime

New Member
Have you benefited from compounded hormone therapy?

If so, you won't be happy with what the FDA is planning.


The FDA has never been a fan of pharmacy compounding, but now it looks to be making a move that could keep millions of people from using a critical therapy.

Here's the deal:

Last year, the agency paid the National Academies of Science, Engineering, & Medicine to do a study of compounded hormone therapy (cBHT). The study concluded that there isn't much
clinical evidence for or against its use. But then NASEM recommended that cBHT be restricted — which is exactly what the FDA wanted it to say.

Never mind that millions of Americans use cBHT every day and rely on it. Never mind that the study didn't find any significant negative effects of cBHT. Oh, and never mind that the
NASEM study didn't even ask the basic question: Does cBHT work for patients? (It does. Very well.)

And now:

The FDA is using that study — yes, the one it paid for — as an excuse to consider limiting compounded hormone therapy.

You read that right:
If you or someone you know uses cBHT, it might not be available any more.

Luckily, members of the U.S. House of Representatives have written a joint letter to the FDA commissioner, asking that the agency not limit compounded hormone therapy.
You can help protect hormone therapy by asking your member of Congress to sign
these letters!

Ask your U.S. House member to sign the joint letter to FDA sponsored by Reps. Pocan, Herrera-Beutler, Cuellar, and Roe.

We’ve made it easy for you: Click the box below, and you’ll find a pre-written message — feel free to customize it — to send to your elected officials. Takes less than two minutes
to do it.

Sent
 

Blackhawk

Member
The narrative of the message is not my style. I wrote:

I'm a constituent of yours from CITY, STATE. I'm writing to request you sign on to the bipartisan joint congressional letter to FDA Commissioner Stephen Hahn regarding Compounded Bioidentical Hormone Therapy (cHBT). The letter is penned by Reps. Pocan, Roe, Cuellar, and Herrera-Beutler. Please vote against this attempt to restrict and eliminate compounded hormone therapy to patients like me, AS PRESCRIBED BY MY DOCTOR!

The FDA commissioned the National Academies of Science, Engineering & Medicine to do a study of compounded bioidentical hormone therapy (cHBT). The study and the resulting recommendations drawn from it are deeply flawed. The NASEM study committee involved no physicians or academicians with pharmacy compounding expertise, nor expertise in compounded hormone therapy.

The study concluded that there isn't much clinical evidence for or against its use. However, the resulting recommendation is to enact restrictions on compounded hormone therapy. This is non-sensical and negatively affects those of us who have used this therapy successfully for years. Many thousands or more Americans like me benefit from this therapy and patient outcome data show that cBHT is safe and effective.

I source my compounded medications from a PCAB Accredited, FDA Registered 503B pharmacy.

About 503B certification: 503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations

These standards for this level of compounding pharmacy are designated by the FDA, and are stringent. It is hypocritical for the FDA to grant such licensure while simultaneously trying to limit the ability of these companies based on a flawed recommendation based on a flawed study that did not even gather evidence to show that a problem exists.

Compounded hormone therapies are customized to the needs of specific patients like me and essential to my healthcare. The FDA's attempt to discontinue the availability of this therapy is unfounded.

Thank you for your action on this request. I have contacted you before on federal land management issues and appreciate your like minded support.
 
Last edited:

Nelson Vergel

Founder, ExcelMale.com
Thanks, guys.

And this is even separate from this other absurd attack on our access:


 

Willyt

Active Member
Can someone please explain in layman’s term what is cHBT and how does it differ from TRT? Is this targeting the compounding pharmacies? If so, what and who is driving this effort?
 

Nelson Vergel

Founder, ExcelMale.com
From CompoundingToday.com

The "Clinical Utility" of Compounded Bioidentical Hormone Therapy (cBHT)


"Six Recommendations"



Here are the six general recommendations from the NASEM HRT Report:

  1. Prescribers and compounding pharmacists should restrict the use of [compounded bioidentical hormone therapy] cBHT preparations.

  2. The (FDA) Pharmacy Compounding Advisory Committee should review select bioidentical hormone therapies and dosage forms as candidates for the FDA Difficult to Compound List.

  3. Improve education for prescribers and pharmacists who market, prescribe, compound, and dispense cBHT preparations.

  4. Additional federal and state-level oversight is needed to better address public health and clinical concerns regarding the safety and effectiveness of cBHT.

  5. Collect and disclose conflicts of interest.

  6. Strengthen and expand the evidence base on safety, effectiveness, and use of cBHT preparations.


Each of the "Recommendations" is accompanied with additional explanations. We will include two Recommendations with explanations in three separate Newsletters. We have presented these previously, but the ramifications are so great that we will repeat them.

RECOMMENDATION 1
Restrict the use of cBHT preparations.


Prescribers should restrict the use of cBHT preparations to the following: documented allergy to an active pharmaceutical ingredient or excipient of FDA-approved drug product, or a documented requirement for a different dosage form. Patient preference alone should not determine the use of cBHT preparations.
In general, the potency of cBHT doses should not exceed those of FDA-approved hormone therapy products because of potential safety concerns. Any use of cBHT, including therapy for gender dysphoria, should align with established clinical guidance and require documentation of shared decision making and rigorous monitoring for long-term risks.
Prescribers and compounding pharmacists should clearly explain the limited evidence-based information about the safety and effectiveness of cBHT preparations. They should inform patients that compounded preparations are not FDA-approved.


EDITOR'S BRIEF COMMENT ON RECOMMENDATION 1
This recommendation encroaches on the physician-patient relationship and provides no substantive reason for "restricting" the use of cBHT preparations. Patients generally request cBHT preparations after trying FDA-approved products without satisfactory relief. Dosing is dependent upon the physicians' judgment and patient response and monitoring. After decades of use of hormone products, their clinical safety and effectiveness have been well-documented.


RECOMMENDATION 2
Review select bioidentical hormone therapies and dosage forms as candidates for the FDA Difficult to Compound List.

The Pharmacy Compounding Advisory Committee should review the following bioidentical hormone therapies as candidates for FDA's Difficult to Compound List: estradiol, estrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate. These candidates have safety and efficacy concerns related to the lack of bioavailability data and product-to-product variability as a result of drug formulation differences, stability, and quality control.
The Pharmacy Compounding Advisory Committee should consider all cBHT preparations formulated in pellet dosage form as candidates for FDA's Difficult to Compound List.


EDITOR'S COMMENT ON RECOMMENDATION 2
As is quite evident, the committee approached cBHT compounding from an FDA New-Drug-Application point of view which is not applicable to compounding individual cBHT prescriptions for individual patients. These preparations have been safely and effectively compounded for over 50 years with millions of treated and satisfied patients and are not difficult to compound. The FDA Difficult to Compound list should be limited to those products with demonstrated difficulty to compound leading to documented safety issues.

 

Nelson Vergel

Founder, ExcelMale.com
Can someone please explain in layman’s term what is cHBT and how does it differ from TRT? Is this targeting the compounding pharmacies? If so, what and who is driving this effort?
Yes, this is targeting compounding pharmacies.

Pharma testosterone gels cost anywhere from $680 to $1000 per month. Compounded testosterone creams cost around $50-$75 per month.
The pharma industry has more lobbyists in Congress than any other industry.

"Drugmakers have spent more than $129 million through September, slightly down from nearly $133 million at this time last year, but still far more than any other industry.

The larger pharmaceutical / health products industry, which includes medical devices and dietary supplement companies along with drugmakers, spent $228 million through the third quarter of 2019, a record-breaking pace that is up $10 million from this time last year."

Source: Big Pharma continues to top lobbying spending

.
 

rustylwb

New Member
Have you benefited from compounded hormone therapy?

If so, you won't be happy with what the FDA is planning.


The FDA has never been a fan of pharmacy compounding, but now it looks to be making a move that could keep millions of people from using a critical therapy.

Here's the deal:

Last year, the agency paid the National Academies of Science, Engineering, & Medicine to do a study of compounded hormone therapy (cBHT). The study concluded that there isn't much
clinical evidence for or against its use. But then NASEM recommended that cBHT be restricted — which is exactly what the FDA wanted it to say.

Never mind that millions of Americans use cBHT every day and rely on it. Never mind that the study didn't find any significant negative effects of cBHT. Oh, and never mind that the
NASEM study didn't even ask the basic question: Does cBHT work for patients? (It does. Very well.)

And now:

The FDA is using that study — yes, the one it paid for — as an excuse to consider limiting compounded hormone therapy.

You read that right:
If you or someone you know uses cBHT, it might not be available any more.

Luckily, members of the U.S. House of Representatives have written a joint letter to the FDA commissioner, asking that the agency not limit compounded hormone therapy.
You can help protect hormone therapy by asking your member of Congress to sign
these letters!

Ask your U.S. House member to sign the joint letter to FDA sponsored by Reps. Pocan, Herrera-Beutler, Cuellar, and Roe.

We’ve made it easy for you: Click the box below, and you’ll find a pre-written message — feel free to customize it — to send to your elected officials. Takes less than two minutes
to do it.

I'm In. signed and sealed. RB
 

Willyt

Active Member
Yes, this is targeting compounding pharmacies.

Pharma testosterone gels cost anywhere from $680 to $1000 per month. Compounded testosterone creams cost around $50-$75 per month.
The pharma industry has more lobbyists in Congress than any other industry.

"Drugmakers have spent more than $129 million through September, slightly down from nearly $133 million at this time last year, but still far more than any other industry.

The larger pharmaceutical / health products industry, which includes medical devices and dietary supplement companies along with drugmakers, spent $228 million through the third quarter of 2019, a record-breaking pace that is up $10 million from this time last year."

Source: Big Pharma continues to top lobbying spending

.
Count me in!
 
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