If there anyway to send thousands of emails etc to FDA. Are compounds even fighting . Can we go Eli Lilly headquarters’s and march with signs . I can’t stand Eli Lilly
So what can we do? I can't afford name brand and my insurance does not cover it! I have been on compound for three years and will do anything to continue. If ever there was a David and Goliath moment this is it. Big Pharma has its thumb on every regulatory organisation that affects their business and I see no way to fight them. Anyone have a prayer, slingshot and a stone?
For those following the FDA’s proposed changes affecting compounded GLP-1 medications like tirzepatide, semaglutide, and liraglutide, this is a good time to consider submitting a public comment.
The FDA is currently considering whether to exclude these medications from the 503B Bulks List. In plain English, this could further limit the ability of outsourcing facilities to compound these medications, which may affect affordability, access, and continuity of care for patients who have relied on compounded GLP-1 options.
This matters because many patients did not start these medications casually. For some, compounded access was the only financially realistic pathway to begin treatment. In my case, I was able to start tirzepatide because it was available through Priority Meds for about $135/month and I could pay through my FSA. Anything significantly higher would likely be unaffordable for me, and I know many Americans would need the price to be even lower. A pathway closer to $20/month could be life-changing for people facing obesity, diabetes risk, metabolic disease, cardiovascular risk, limited mobility, or poverty.
I support medication safety and FDA oversight. But I also believe FDA needs to hear from real patients about affordability, continuity of care, rural access, transparency, and the risk of financial harm when people have already enrolled in longer-term treatment programs.
Public comments are one way to make that patient experience part of the official record.
The usual place to submit comments is Regulations.gov. The link appears to be down at the moment, and I have sent an IT support message about the error:
When the site is working again, you can search for:
Docket No. FDA-2018-N-3240
Suggested points to include in your comment:
-Whether compounded GLP-1 access made treatment financially possible for you;
-What you are currently paying and what price would become unaffordable;
-Whether you are rural, self-pay, underinsured, or facing limited local access to care;
-Whether you enrolled in a longer-term program and are worried about medication continuity;
-Why abrupt interruption could affect your health, trust, or financial stability;
-Why patients deserve clear disclosure about whether they are receiving FDA-approved or compounded medication;
-Why companies should provide transition plans, refunds, or credits if they cannot fulfill long-term medication programs.
You do not need to write like a lawyer. A clear personal story is valuable. FDA needs to hear how this policy affects real people, not just manufacturers, pharmacies, and telehealth companies.
A simple comment could say:
“I support FDA’s role in protecting patients from unsafe or poor-quality compounded medications. However, I ask FDA to consider the affordability and continuity-of-care impact on patients who began GLP-1 treatment through compounded medication because FDA-approved alternatives were financially out of reach. If this pathway is restricted, patients need transparency, transition planning, and protection from financial harm.”
Please consider submitting a comment once the Regulations.gov page is working again.
If there anyway to send thousands of emails etc to FDA. Are compounds even fighting . Can we go Eli Lilly headquarters’s and march with signs . I can’t stand Eli Lilly
Yes, go to the FDA website and find where to send comments about compounding. They are taking public input until sometime in June.
Possible link to complain to the FDA. Dave might have a more specific one.
https://www.fda.gov/patients/guide-submitting-comments-fda
So what can we do? I can't afford name brand and my insurance does not cover it! I have been on compound for three years and will do anything to continue. If ever there was a David and Goliath moment this is it. Big Pharma has its thumb on every regulatory organisation that affects their business and I see no way to fight them. Anyone have a prayer, slingshot and a stone?
I’m truly so sick of the pharmaceutical company’s greed.
There is no humanity in this.
It’s never about patient care with them. It is always about their bottom line and growing their wealth…. for themselves and their stakeholders.
For those following the FDA’s proposed changes affecting compounded GLP-1 medications like tirzepatide, semaglutide, and liraglutide, this is a good time to consider submitting a public comment.
The FDA is currently considering whether to exclude these medications from the 503B Bulks List. In plain English, this could further limit the ability of outsourcing facilities to compound these medications, which may affect affordability, access, and continuity of care for patients who have relied on compounded GLP-1 options.
This matters because many patients did not start these medications casually. For some, compounded access was the only financially realistic pathway to begin treatment. In my case, I was able to start tirzepatide because it was available through Priority Meds for about $135/month and I could pay through my FSA. Anything significantly higher would likely be unaffordable for me, and I know many Americans would need the price to be even lower. A pathway closer to $20/month could be life-changing for people facing obesity, diabetes risk, metabolic disease, cardiovascular risk, limited mobility, or poverty.
I support medication safety and FDA oversight. But I also believe FDA needs to hear from real patients about affordability, continuity of care, rural access, transparency, and the risk of financial harm when people have already enrolled in longer-term treatment programs.
Public comments are one way to make that patient experience part of the official record.
The usual place to submit comments is Regulations.gov. The link appears to be down at the moment, and I have sent an IT support message about the error:
https://www.regulations.gov/service-down
When the site is working again, you can search for:
Docket No. FDA-2018-N-3240
Suggested points to include in your comment:
-Whether compounded GLP-1 access made treatment financially possible for you;
-What you are currently paying and what price would become unaffordable;
-Whether you are rural, self-pay, underinsured, or facing limited local access to care;
-Whether you enrolled in a longer-term program and are worried about medication continuity;
-Why abrupt interruption could affect your health, trust, or financial stability;
-Why patients deserve clear disclosure about whether they are receiving FDA-approved or compounded medication;
-Why companies should provide transition plans, refunds, or credits if they cannot fulfill long-term medication programs.
You do not need to write like a lawyer. A clear personal story is valuable. FDA needs to hear how this policy affects real people, not just manufacturers, pharmacies, and telehealth companies.
A simple comment could say:
“I support FDA’s role in protecting patients from unsafe or poor-quality compounded medications. However, I ask FDA to consider the affordability and continuity-of-care impact on patients who began GLP-1 treatment through compounded medication because FDA-approved alternatives were financially out of reach. If this pathway is restricted, patients need transparency, transition planning, and protection from financial harm.”
Please consider submitting a comment once the Regulations.gov page is working again.
5-4-2026,
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