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

[HealthMan]

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

Couldn’t compounding pharmacies like Empower purchase brand name drugs like Testosterone, HCG, anastrozole etc and resell them at a mark up? So that TRT clinics could continue to send prescriptions to these compounding pharmacies. I know this doesn’t fix the problem of affordability and lack of treatment options for some people (specially women) but at least fix some of the accessibility issues.
The focus remains to avoid this to happen but just thinking about a plan B in case worst case scenario happens.

 

[Arcane]

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

Why couldn't HRT clinics just implement a subscription-based service and prescribe retail pharmacy TRT, rather than making their profit from markups? That way we can still get reasonable protocols catered to our individual needs and the clinics can still profit.





Id gladly pay a monthly or annual prescription if it meant I could continue using Defy

 

[Nelson Vergel]

Please forward this link to your friends. I think that I described issues there more clearly:

Tell the FDA and Congress to Protect Access to Affordable Hormone Treatments

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

www.discountedlabs.com

 

[Nelson Vergel]

Couldn’t compounding pharmacies like Empower purchase brand name drugs like Testosterone, HCG, anastrozole etc and resell them at a mark up? So that TRT clinics could continue to send prescriptions to these compounding pharmacies. I know this doesn’t fix the problem of affordability and lack of treatment options for some people (specially women) but at least fix some of the accessibility issues.
The focus remains to avoid this to happen but just thinking about a plan B in case worst case scenario happens.

The cost is just too high to stay in business with a retail model like that. You couldn’t sustain a sketchy testosterone mill operation with that model let alone how clinics operate to ensure everything is legitimate and correct. There is not enough markup on lab tests, and after you calculate in the cost of a provider’s time for a consult plus their time afterward finishing up notes and such, you really are not profiting at all off of a $90 or $165 consult in the case of an MD since they cost even more. Consults are almost the equivalent of what loss leaders would be in retail where you break even or lose a little (consult) to sell more product or in this case prescribe medications to get people feeling better.

It would be like a urologist not getting reimbursed by any health insurance and only trying to stay in business off of patients’ $25 office copay for a visit and nothing more. Not going to work. The monthly subscription price would need to be so high that you are right back where you started paying for “overpriced” medications, just in a less clear way which to me is not being upfront and honest to patients.

What most price-conscious consumers don’t realize is how much money it costs for clinics to turn the lights on every day; to be able to do that and go to sleep knowing that you are doing everything legitimate and not screwing people over just to take their money.

We will see what happens.

 

[HealthMan]

The cost is just too high to stay in business with a retail model like that. You couldn’t sustain a sketchy testosterone mill operation with that model let alone how clinics operate to ensure everything is legitimate and correct. There is not enough markup on lab tests, and after you calculate in the cost of a provider’s time for a consult plus their time afterward finishing up notes and such, you really are not profiting at all off of a $90 or $165 consult in the case of an MD since they cost even more. Consults are almost the equivalent of what loss leaders would be in retail where you break even or lose a little (consult) to sell more product or in this case prescribe medications to get people feeling better.

It would be like a urologist not getting reimbursed by any health insurance and only trying to stay in business off of patients’ $25 office copay for a visit and nothing more. Not going to work. The monthly subscription price would need to be so high that you are right back where you started paying for “overpriced” medications, just in a less clear way which to me is not being upfront and honest to patients.

What most price-conscious consumers don’t realize is how much money it costs for clinics to turn the lights on every day; to be able to do that and go to sleep knowing that you are doing everything legitimate and not screwing people over just to take their money.

We will see what happens.

Yeah. They will have to adopt an annual fee model and charge more for medication.

 

[Nelson Vergel]

It's not that easy for compounding pharmacies to buy commercial products. The prices you see on Good Rx etc are exclusive contract prices between the supplier or manufacturer and the company, and they are subject to change at any time. Compounding pharmacies are not afforded contract prices and even when they are able to secure it, its only good month to month which would be challenging to stay ahead of billing. The majority of the cost of compounded medication is in the labor used to fill and dispense the medication, therefore there would still have to be a margin added to commercial drugs to cover the operation and compliance requirements.

Not to mention commercial products vary in availability.

Some of you guys are also neglecting the female population that does not have any commercial BHRT products except for expensive progesterone capsules, not to mention other bioidenticals that are used in the male population.

This will also affect the urologists as their institutions and insurances will use this NASEM study to prevent them from prescribing any bioidentical hormones or compounded medications.

 

[Arcane]

It's not that easy for compounding pharmacies to buy commercial products. The prices you see on Good Rx etc are exclusive contract prices between the supplier or manufacturer and the company, and they are subject to change at any time. Compounding pharmacies are not afforded contract prices and even when they are able to secure it, its only good month to month which would be challenging to stay ahead of billing. The majority of the cost of compounded medication is in the labor used to fill and dispense the medication, therefore there would still have to be a margin added to commercial drugs to cover the operation and compliance requirements.

Not to mention commercial products vary in availability.

Some of you guys are also neglecting the female population that does not have any commercial BHRT products except for expensive progesterone capsules, not to mention other bioidenticals that are used in the male population.

This will also affect the urologists as their institutions and insurances will use this NASEM study to prevent them from prescribing any bioidentical hormones or compounded medications.

I just reached out to Defy on the FDA potential ban situation.



Their response:

"Thank you for reaching out to us with your questions. We are aware of the FDA changes when it comes to compounding pharmacies. As for now, we are still able to ship Testosterone, but that has changed for HCG. We are able to send prescriptions to retail pharmacies in most states for our patient's convenience as well. If there are any further changes that come from the FDA, we will be transparent in our communication with all of our patients and give as much notice as possible to any changes we foresee. I hope this helps to answer your questions, and if you have any further questions or concerns, feel free to contact our office at your convenience."

 

[HealthMan]

All this discussion is valid as we all worry about the consequences of the FDA banning compounded hormones. But lets focus in trying to avoid this. Last i checked the website that @Nelson Vergel put together to fight this he only got 22% of the target number of people. Lets forward to friends and family and have them participate as well please!!

 

[Nelson Vergel]

Let’s say that only 10 percent of my 43k members here and 25K members on Facebook sent letters. That would amount to almost 7K signatures. I am only at 1,500 today after 3 days. I will keep trying for a few more weeks. Thanks for your help.

 

[HealthMan]

Let’s say that only 10 percent of my 43k members here and 25K members on Facebook sent letters. That would amount to almost 7K signatures. I am only at 1,500 today after 3 days. I will keep trying for a few more weeks. Thanks for your help.

Nelson
A lot of celebrities use bHRT. Have you tried to engage these celebrities in their social media platforms? Are they even aware of this problem? If one celebrity backs this up it can really become viral

 

[Nelson Vergel]

Nelson
A lot of celebrities use bHRT. Have you tried to engage these celebrities in their social media platforms? Are they even aware of this problem? If one celebrity backs this up it can really become viral

Why don’t you help me by doing so ? Post the link in post number 23.

 

[HealthMan]

Why don’t you help me by doing so ? Post the link in post number 23.

I have been doing so yes. Hopefully someone reads and join the cause

 

[Nelson Vergel]

Thank you

 

[Arcane]

Let’s say that only 10 percent of my 43k members here and 25K members on Facebook sent letters. That would amount to almost 7K signatures. I am only at 1,500 today after 3 days. I will keep trying for a few more weeks. Thanks for your help.

I spread the link to reddit and Derek from More Plates More dates community.

I will try to spread it to Discord as well

 

[Gianluca]

thank you @Nelson Vergel , sorry it took me so long. I was traveling for 3 weeks. I just submitted both, and sharing it. Website works well and it is really easy to submit the paper to FDA, thanks for the work Nelson

 

[Nelson Vergel]

thank you @Nelson Vergel , sorry it took me so long. I was traveling for 3 weeks. I just submitted both, and sharing it. Website works well and it is really easy to submit the paper to FDA, thanks for the work Nelson

Thank you !

 

[HealthMan]

Thank you !

Is it feasible for compounding giants like Empower to apply for a BLA and then be able to produce and sell HCG or the cost is too high to make economic sense?

 

[Nelson Vergel]

Is it feasible for compounding giants like Empower to apply for a BLA and then be able to produce and sell HCG or the cost is too high to make economic sense?

Yes, they did. It will take a while to get a BLA approved.

 

[Outcome]

I saw the new facility 2 weeks ago when I picked up meds. It’s at least twice the size of the old location. It’s impressive! Right next door to the horse racing track Lol

 

[Nelson Vergel]

I saw the new facility 2 weeks ago when I picked up meds. It’s at least twice the size of the old location. It’s impressive! Right next door to the horse racing track Lol

Yes. It's very impressive with state-of-the-art pharmaceutical equipment. Over 115,000 sq feet in addition to the 50K square feet of the old building.