Nelson Vergel is Seeking Input: Tell the FDA to Stop Attacking Compounded Hormones

[Nelson Vergel]

Hello Guys

I am about to launch this new site and I am seeking constructive feedback. I would encourage you to "Take Action" on each of the two campaigns to see how the site works. Thank you!!

Take Action

Tell the FDA and Congress to Protect Your Access to Affordable Compounded Hormones

hormoneaccesscoalition.org

 

[Nelson Vergel]

@madman @Vince @Cataceous @readalot @Gman86 @Gianluca @xqfq @HealthMan @Dr Justin Saya MD @Jason Sypolt

 

[Guided_by_Voices]

I got to the page where "Submit" is located but I could not get it to let me address the message being created or enter my name at the end of the message. Is that done automatically?

Otherwise, I think this is fantastic idea! Thanks for doing this. If you are looking for best practices, my understanding is that the group that has fought to keep Kratom legal ( the American Kratom Association, I think) is a good model to learn from.

 

[HealthMan]

Hello Guys

I am about to launch this new site and I am seeking constructive feedback. I would encourage you to "Take Action" on each of the two campaigns to see how the site works. Thank you!!

Hormone Access Coalition - Take Action!

The Hormone Access Coalition is a consumer-driven organization that advocates for affordable access to personalized hormone treatments in the U.S. and to educate patients and providers about legislation that may diminish the current available to life-changing therapies.

hormoneaccesscoalition.org

View attachment 18306

Done.

Hello Guys

I am about to launch this new site and I am seeking constructive feedback. I would encourage you to "Take Action" on each of the two campaigns to see how the site works. Thank you!!

Hormone Access Coalition - Take Action!

The Hormone Access Coalition is a consumer-driven organization that advocates for affordable access to personalized hormone treatments in the U.S. and to educate patients and providers about legislation that may diminish the current available to life-changing therapies.

hormoneaccesscoalition.org

View attachment 18306

Done

 

[Vince]

Thanks, Nelson

 

[Nelson Vergel]

I got to the page where "Submit" is located but I could not get it to let me address the message being created or enter my name at the end of the message. Is that done automatically?

Yes. It's done automatically. I have edited a few things after I received some great input in private messages. Thanks, guys!

I will blast the internet on Monday!

 

[Jed Dorsey]

Just curious is Nandrolone on the chopping block by the FDA?? I currently get it from a compounding pharmacy for joint pain and it’s awesome!!

 

[Nelson Vergel]

Just curious is Nandrolone on the chopping block by the FDA?? I currently get it from a compounding pharmacy for joint pain and it’s awesome!!

Not specifically listed but I would not be surprised if they add it later.

All compounded hormone injections, creams, gels, nasal, pellets, etc formulations will be banned.


The Committee recommended that estradiol, estrone, estradiol cypionate, estriol, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate and all pellet cBHT therapies be considered candidates for the FDA “Difficult to Compound List.”

 

[Arcane]

If this happens... we're screwed. I cant trust UGL long term

 

[Arcane]

Also I noticed that Testosterone enanthate isnt on the list

 

[Nelson Vergel]

Please tell the FDA and Congress to protect and allow access to compounded hormones.

The FDA has already banned three old generic compounded fertility hormones and is now actively considering blocking access to eleven affordable compounded hormone replacement products. Please read the summary below so that you can understand the two issues that affect millions of people in the...

www.excelmale.com

 

[Nelson Vergel]

Also I noticed that Testosterone enanthate isnt on the list

All hormone injections and creams will be banned. Don't assume they will leave an ester untouched.

 

[Dicky]

This is really slick Nelson. We all owe you a debt of gratitude for pulling that together. It makes submitting feed back very simple.

 

[Nelson Vergel]

This is really slick Nelson. We all owe you a debt of gratitude for pulling that together. It makes submitting feed back very simple.

Thank you. It took me weeks to go though FDA regulations, NASEM report, NASEM analysis, and other documents. If people don't raise hell, we will lose access.
I am glad I was an HIV activist for over 30 years since that taught me a lot. We don't take shit from the FDA or Congress. I hope I can wake up men and women to the power we all have if we stick together. We will see....

 

[Dicky]

Thank you. It took me weeks to go though FDA regulations, NASEM report, NASEM analysis, and other documents. If people don't raise hell, we will lose access.
I am glad I was an HIV activist for over 30 years since that taught me a lot. We don't take shit from the FDA or Congress. I hope I can wake up men and women to the power we all have if we stick together. We will see....

Amen. Unless we do something those worthless corrupt bureaucrats at the FDA will take our meds away.

I had not realized all the work that you had put into this. That sounds like a lot of time spent on this. So I thank you again. I doubt that anything like this would have happened had you not done it.

 

[Arcane]

Thank you. It took me weeks to go though FDA regulations, NASEM report, NASEM analysis, and other documents. If people don't raise hell, we will lose access.
I am glad I was an HIV activist for over 30 years since that taught me a lot. We don't take shit from the FDA or Congress. I hope I can wake up men and women to the power we all have if we stick together. We will see....

Say this goes through.. will we still be able to get Testosterone from regular pharmacies via Defy?

 

[madman]

Not specifically listed but I would not be surprised if they add it later.

All compounded hormone injections, creams, gels, nasal, pellets, etc formulations will be banned.


The Committee recommended that estradiol, estrone, estradiol cypionate, estriol, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate and all pellet cBHT therapies be considered candidates for the FDA “Difficult to Compound List.”

Updated June 07, 2021

Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act


503B Category 1: Bulk Drug Substances Under Evaluation (see pdf)

** Designates bulk drug substances that are components of FDA approved drugs

• Anastrazole**
• DHEA (dehydroepiandrosterone) **
• Estradiol Cypionate**
• Estradiol**
• Estriol
• Estrone**
• Finasteride**
• Minoxidil**

• Nandrolone Decanoate**
• Progesterone**
• Testosterone**
• Testosterone Cypionate**
• Testosterone Propionate**
• Tretinoin**




Updated November 2, 2021

Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act


Notice of Updates to Section 503A Categories

Additions to category 1

o Ammonium Tetrathiomolybdate – This bulk drug substance was nominated with sufficient supporting information to permit FDA to evaluate it and may be eligible for inclusion on the 503A Bulks List

o Enclomiphene Citrate- This bulk drug substance was nominated with sufficient supporting information to permit FDA to evaluate it and may be eligible for inclusion on the 503A Bulks List


503A Category 1 – Bulk Drug Substances Under Evaluation (see pdf)

• 7 Keto Dehydroepiandrosterone
• Enclomiphene Citrate
• L-Citrulline
• Melatonin
• Pregnenolone

 

[Nelson Vergel]

Cash-based online and most TRT local clinics can stay in business because of hormone product and blood test margins. So, if the FDA bans 11 compounded hormones, all these clinics will take a hit. They would have to pivot by calling in prescriptions to regular pharmacies like Walgreens, etc. They do not get any margins from that. Men that get TRT paid by insurance will still have access to pharma name-brand products. hCG is not paid by insurance, though. Another issue is that many online TRT clinics do not have a physician licensed in every state, so there will be states that they won't be able to serve. The consumer will be affected since hCG, FSH, HMG, TRT creams, TRT pellets, and other TRT options are much more expensive as name-brand products. Another issue is that hCG, FSH and HMG are usually on back order at regular pharmacies. Last but not least, every insurance company has a very limited formulary of TRT or HRT options since they make deals with specific pharma companies for pricing. More details on the hCG, FSH, HMG story: The FDA Blocked Your Access to Affordable Compounded hCG, FSH and hMG - Hormone Access Coalition and TRT, HRT: FDA Aims at Blocking Your Access to Affordable HRT, TRT, and Other Hormones - Hormone Access Coalition

 

[Arcane]

Cash-based online and most TRT local clinics can stay in business because of hormone product and blood test margins. So, if the FDA bans 11 compounded hormones, all these clinics will take a hit. They would have to pivot by calling in prescriptions to regular pharmacies like Walgreens, etc. They do not get any margins from that. Men that get TRT paid by insurance will still have access to pharma name-brand products. hCG is not paid by insurance, though. Another issue is that many online TRT clinics do not have a physician licensed in every state, so there will be states that they won't be able to serve. The consumer will be affected since hCG, FSH, HMG, TRT creams, TRT pellets, and other TRT options are much more expensive as name-brand products. Another issue is that hCG, FSH and HMG are usually on back order at regular pharmacies. Last but not least, every insurance company has a very limited formulary of TRT or HRT options since they make deals with specific pharma companies for pricing. More details on the hCG, FSH, HMG story: The FDA Blocked Your Access to Affordable Compounded hCG, FSH and hMG - Hormone Access Coalition and TRT, HRT: FDA Aims at Blocking Your Access to Affordable HRT, TRT, and Other Hormones - Hormone Access Coalition

When can we expect them make a move?

 

[Nelson Vergel]

When can we expect them make a move?

Anytime. They received the negative NASEM report last year. They already banned compounded hCG, FSH and HMG.