Compounded Bioidentical Hormone Therapy (cBHT)- FDA Ban Anticipated

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Nelson Vergel

Founder, ExcelMale.com
Compounding pharmacies should be aware of recent developments in the law surrounding bioidentical hormone therapy (cBHT). In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a medication to fit the unique need of a patient which cannot be met with commercially available products. Compounded drugs are not FDA-approved. The Food and Drug Administration (FDA) has been looking at cBHT (e.g. estriol, estradiol, progesterone) for a while and has commissioned several studies to look into the safety and efficacy of these ingredients. Most recently, FDA convened a National Academies of Science, Engineering, and Medicine (NASEM) committee to study the clinical utility of treating patients with cBHT. The FDA will utilize the committee’s findings to make a final decision on the fate of cBHT. In July 2020, the NASEM study released unfavorable results reporting the widespread use of cBHT as a public health concern and recommending that prescribers restrict the use of cBHT to two circumstances: when a patient is allergic to an ingredient in an FDA-approved hormone product, and when a patient requires a specific dosage form unavailable for an FDA-approved product. As a consequence of the public health concern, FDA will likely move quickly to ban these medications.

Over 2.5 million women in the U.S. rely on bioidentical hormones for menopause, fertility challenges, or other hormonal imbalances. Public access restrictions will have far reaching consequences for patients. Despite being compounded safely for decades, FDA has nominated and its Pharmacy Compounding Advisory Committee (PCAC) is currently reviewing cBHTs, for the FDA’s Demonstrably Difficult to Compound List items that appear on the list, when it is final, will no longer be able to be utilized by compounding pharmacies in the mixing of cBHT. FDA will have to issue a “proposed rulemaking” to actually add these hormones to the Difficult to Compound List. It is also possible that FDA will issue a draft guidance that restricts use of cBHT as outlined in the NASEM’s report recommendations. Frier Levitt has experience submitting “comments” to the FDA in connection with the “Difficult to Compound” list, on behalf of compounding pharmacies and trade groups.

One of the committee’s recommendations is that “the federal government and State Boards of Pharmacy should expand and improve oversight of 503A “traditional” pharmacies to ensure quality standards for every cBHT dispensed”. Is this crux of the matter? Has FDA overreached in implementing the provisions of the Drug Quality and Security Act, all but halting common compounding practices that have been safely performed for years and on which patients with legitimate needs for compounded medications rely? Has the FDA done so by circumventing the federal Administrative Procedure Act (“APA”), issuing “guidance documents” to implement policies rather than following the statutory rule-making process that requires stakeholder input regarding proposed regulations? The APA is an important tool in the valid rule making process, as well in a democratic form of government that celebrates separation of powers.

There is a public docket allowing public comments concerning the products nominated for the list. Interested parties need to prepare and submit comments to FDA on the docket in anticipation of FDA acting to ban cBHT. The comments should urge FDA to remove the nomination of these compounds from the list. Further, comments should opine that the ingredients are not difficult to compound but are being considered for the list for other reasons (e.g. the systematic chiseling away of ingredients allowed to be compounded). A non-biased review of the vast clinical literature (Safety & Efficacy) is needed to rebut the findings of the FDA commissioned report. There have been no trials comparing the safety of synthetic hormones versus bioidentical hormone formulations.




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Nelson Vergel

Founder, ExcelMale.com




 

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 compounding, but now it looks to be making a move that could keep millions of people from using a critical medication.

Here's the deal:

Last year, the FDA paid for a study of compounded hormone therapy (cBHT). The result: The study concluded that there isn't much clinical evidence for or against cBHT.

Strangely, though, the study recommended that cBHT be restricted. (Well, not so strange. That was exactly what the FDA asked 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 study didn't even ask patients whether cBHT worked! (It does. Very well.)

But now:

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.

You read that right: If you or someone you know uses cBHT, it might soon be a lot harder to get.

Neighborhood compounding pharmacies are trying to fight back, but they need your help. It’s simple: Tell us your story about how compounded hormone therapy has affected your life.

We’re collecting thousands of these stories to try to convince the FDA that compounded hormone therapy is too important to risk.

Please, go to A4PC.org/cbhtandme. Tell us a little about yourself and how cBHT has changed your life or your loved one’s. It only takes a few minutes, and it will help preserve your access to HRT formulations.
 

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 compounding, but now it looks to be making a move that could keep millions of people from using a critical medication.

Here's the deal:

Last year, the FDA paid for a study of compounded hormone therapy (cBHT). The result: The study concluded that there isn't much clinical evidence for or against cBHT.

Strangely, though, the study recommended that cBHT be restricted. (Well, not so strange. That was exactly what the FDA asked 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 study didn't even ask patients whether cBHT worked! (It does. Very well.)

But now:

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.

You read that right: If you or someone you know uses cBHT, it might soon be a lot harder to get.

Neighborhood compounding pharmacies are trying to fight back, but they need your help. It’s simple: Tell us your story about how compounded hormone therapy has affected your life.

We’re collecting thousands of these stories to try to convince the FDA that compounded hormone therapy is too important to risk.

Please, go to A4PC.org/cbhtandme. Tell us a little about yourself and how cBHT has changed your life or your loved one’s. It only takes a few minutes, and it will help preserve your access to HRT formulations.filled
 

D0UG

New Member
If the FDA implements this prohibition, it will drive patients to foreign suppliers whose quality controls are much lower than the pharmacies. Bad idea but I suspect the pharmaceutical companies are behind it.
 

HealthMan

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 compounding, but now it looks to be making a move that could keep millions of people from using a critical medication.

Here's the deal:

Last year, the FDA paid for a study of compounded hormone therapy (cBHT). The result: The study concluded that there isn't much clinical evidence for or against cBHT.

Strangely, though, the study recommended that cBHT be restricted. (Well, not so strange. That was exactly what the FDA asked 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 study didn't even ask patients whether cBHT worked! (It does. Very well.)

But now:

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.

You read that right: If you or someone you know uses cBHT, it might soon be a lot harder to get.

Neighborhood compounding pharmacies are trying to fight back, but they need your help. It’s simple: Tell us your story about how compounded hormone therapy has affected your life.

We’re collecting thousands of these stories to try to convince the FDA that compounded hormone therapy is too important to risk.

Please, go to A4PC.org/cbhtandme. Tell us a little about yourself and how cBHT has changed your life or your loved one’s. It only takes a few minutes, and it will help preserve your access to HRT formulations.
Done
 

HealthMan

Member
As a plan B will providers like Defy and many others that specialize in HRT be able to offer brand name testosterone, HCG, estradiol etc? For instance Defy already offers brand name testosterone (at a higher price). However no HCG brand name option yet.
 

Nelson Vergel

Founder, ExcelMale.com
As a plan B will providers like Defy and many others that specialize in HRT be able to offer brand name testosterone, HCG, estradiol etc? For instance Defy already offers brand name testosterone (at a higher price). However no HCG brand name option yet.
I would ask them. I see no other option but brand name if this FDA expected decision happens. It's going to hit women harder since there are no pharma creams that have a mixture of hormones for them.
 

Nelson Vergel

Founder, ExcelMale.com
Remember that one of the biggest and strongest lobbyist groups in Congress is the pharmaceutical industry.

The US is actually the county in the developed world with the most consumer choice, but that is eroding in front of us if we are passive about it. Please send your testimonials by clicking on the link above. We need help, not just misdirected anger.
 

lukas_az

Member
FDA = extension of big pharma. their goal is to maximize pharma profits, even if that means death of the patient. their goal is to push poison to just keep you alive without killing you instantly, so you can be fleeced financially over a period of time. effective medicines can NOT be allowed. /rant end
 

Jon H

Member
Nelson,

I've submitted my stories in the past, stating how vital compounded hormones are for my spouse and myself. However, I just don't see it making a difference. This decision has obviously already been made, and the outcome architected, behind closed doors. I'm pretty jaded, so I don't see anything changing unless it's through the courts. Are you aware of any actions being planned by pharmacies like Defy and others, to quickly fight back through the court system if the ban takes place? And if so, what we could do to help support them? The Big Pharma cartel has already bought and paid for Congress, and the FDA.
 

Dicky

Member
I am perfectly willing to fill out a petition and tell my story. But I am unsure of what exactly I am asking the regulators to do. Does anyone have a one or 2 liner that I can borrow? Is it as simple as "please do not ban compounded hormone replacement products"?
 
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