This month's guest author, Joe Nadglowski, is the President and CEO of the Obesity Action Coalition
For the past 20 years, the Obesity Action Coalition (OAC) has advocated for evidence-based treatments for the disease of obesity. In 2010, OAC began challenging the FDA to take serious action in approving new medicines for obesity treatment. Fast forward to today, and you see we now have multiple obesity medications available and many, many more on the way. OAC’s guiding principle has always been that obesity medications should be evidence-based, FDA-approved and covered by health insurance. One particularly difficult challenge we’ve faced in the recent two years is the onset of widespread compounding of GLP-1’s.
OAC has long advised our members against using compounded GLP-1’s. The main reason is FDA’s own words about compounding: “Compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.”, Our ultimate challenge is knowing whether compounded GLP-1’s are safe and effective. There are likely both good and bad compounders, but we don’t have enough evidence to say which ones are good and which ones are bad.
OAC has engaged with meetings with dozens of groups around the issue of compounding to see if we can identify who is compounding correctly and who isn’t. We have observed that:
- Many compounders are reluctant to share the source of their Active Product Ingredient (known as API), the main ingredient in making compounded GLP-1’s, and these are likely coming from outside the US.
- There are no reporting requirements on the number of doses of compounded GLP-1’s being reported to the public.
- Inspections of compounding pharmacies are relatively limited, as are the resources for enforcement.
- The availability of compounded GLP-1’s without a prescription (illicit manufacturing and distribution) is a serious issue.
- Marketing of compounded GLP-1’s often lacks safety information.
- Data collection and peer-reviewed publications on people using compounded products is limited.
- Letting people know how and where to report adverse effects is seriously lacking.
Late last year, the FDA announced that the tirzepatide shortage was over after being in short supply since 2022. Because the FDA allows the compounding of certain drugs only if the commercially available version is in a verified shortage, the FDA has required compounding pharmacies to halt production and preparation of compounded tirzepatide. Similarly, the FDA determined the shortage of semaglutide, another GLP-1 medication in shortage since 2022, to be resolved. The agency has now required compounding pharmacies to halt production and preparation of compounded semaglutide.
For those patients who are currently taking compounded GLP-1’s, there are valid concerns about how they will get their medications. We are strongly encouraging patients to double check their insurance to see if their coverage has changed and then have a conversation with their health care professional around the possibility of switching to a branded obesity medication. For patients that continue to use a compounded GLP-1, we are urging that they actively engage with their healthcare professional so they can assess any unexpected impacts and make sure they are diligently reporting any adverse effects.
OAC’s position is that compounded GLP-1’s aren’t the answer until they meet our long-standing criteria for evidence-based, FDA-approved care. Our concern is that we’ve created an unequitable system of care for obesity. If you have great insurance, you get the highest level of care. If not, you may receive care that is potentially safe and effective through compounding—if you can afford the more modest fees. And if you don’t have good insurance and can’t afford those fees, you get no care at all. We are advocating for a world where people don’t have to make those compromises—and where everyone has access to care.
Learn more at obesityaction.org