Drugmakers have asked FDA to prohibit compounded GLP-1s.
If you take compounded tirzepatide or semaglutide, FDA needs to hear from you.
Read the facts here, then express your concern in a letter to FDA.
Just follow the instructions below — it takes maybe two minutes.
Preserve access to compounded GLP-1 drugs!
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Over the past 30 months, brand-name GLP-1 weight-loss drugs like Ozempic® and Mounjaro® have been in shortage, according to FDA. Compounding pharmacies have been a lifeline for many Americans who depend on these drugs.
As permitted by FDA, compounding pharmacies have been preparing compounded versions of the brand-name drugs. That has allowed patients to have access to (and benefit from) GLP-1 therapy, even while drugmakers have been unable to meet the extraordinary demand.
Now, more than two years into the GLP-1 injectable shortage, drugmakers Eli Lilly and Novo Nordisk have asked FDA to take emergency action to prohibit compounding of tirzepatide and semaglutide, the active pharmaceutical ingredients in both the brand-name and compounded GLP-1 injectables.
It’s an audacious ask, considering millions of doses have safely been prepared and dispensed by compounding pharmacies across the U.S. over the last two years.
What the drugmakers are telling FDA:
- Tirzepatide and semaglutide are so difficult to compound that they must be added to the formal list of prohibited substances.
- The active ingredients that compounders use is inferior to the ingredients used by the drugmakers.
Neither claim is true.
- GLP-1s are not particularly difficult for sterile compounding labs to prepare. (Again, millions of doses have already been successfully compounded and dispensed.)
- FDA itself views the active ingredients in compounded GLP-1s and the brand-name drugs as essentially the same.
The drugmakers also cite concerns about patient safety, pointing to adverse events reported to FDA related to compounded versions of the drugs.
What they don’t say is that the adverse events reported for the compounded versions are remarkably similar to those reported for their own branded drugs. (Nevermind the adverse effects caused by denying patients access to critical medicines that their doctor says they need but which the drugmakers can’t supply.)
In short, the drugmaker claims misrepresent the facts – including the fact that patients who are taking compounded GLP-1s are benefiting from them.
Drugmakers asked FDA to prohibit compounded GLP-1s. Now FDA needs to hear from you.
Asking them not to be fooled by the drugmakers’ misrepresentations.
Urge FDA to reject the requests by Eli Lilly and Novo Nordisk to prohibit the compounding of tirzepatide and semaglutide.
If you rely on a compounded version of one of the GLP-1 drugs while the FDA approved versions are in shortage—share your story.
Send a Letter to FDA Using the Form Below
Our friends at The Alliance for Pharmacy Compounding (APC) have created a convenient, pre-filled letter below. Please review & edit if you would like. Once everything looks good, you can click “Send Message” and it will be sent straight to FDA. You can also choose to receive future alerts from APC.