by Joe Nadglowski, OAC President and CEO

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 in the onset of widespread compounding of GLP-1’s.

OAC’s Stance on Compounding

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,” (source: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss). Our ultimate challenge is knowing whether compounded GLP-1’s are safe and effective. Simply put we don’t know that answer. Scanning the environment, I’d say there are likely both good compounders and bad compounders but our ultimate challenge is we don’t have enough evidence to say which ones are good and which ones are bad. It’s truly buyer beware and we believe nearly impossible to assure you are getting safe medicine.

Our Work on Compounding

OAC has engaged with meetings with dozens of groups around the issue of compounding really trying to see if we can identify who is compounding correctly and who isn’t. A couple of observations:

  1. Compounders are reluctant to share the source of their Active Product Ingredient (known as API), the main ingredient in making compounded GLP-1’s. These are likely coming from outside the US.
  2. While compounding pharmacies are regulated by state pharmacy boards and large-scale versions by the FDA, inspections are relatively limited as are the resources for enforcement.
  3. There are no reporting requirements on the number of doses of compounded GLP-1’s being reported to the public. We see estimates of 1 to 10 million people using compounded GLP-1’s but don’t know that actual number.
  4. The availability of compounded GLP-1’s without a prescription (illicit manufacturing and distribution) is a serious issue. These are serious medicines for a serious problem called obesity and need to be used under a healthcare providers care.
  5. Marketing of compounded GLP-1’s often lacks safety information (and at times reminds us of marketing of get thin quick/snake-oil products of the past).
  6. Data collection and peer-reviewed publications on people using compounded products is limited. Build the evidence base to give us the information we need to evaluate safety and effectiveness.
  7. Letting folks know how and where to report adverse events is seriously lacking.

But Branded GLP-1’s are so Expensive

OAC definitely agrees that the branded GLP-1’s are too expensive and the pharmaceuticals companies haven’t done enough to make access to these medicines accessible for those of lower socio-economic status through creating appropriate patient assistance programs. We’ve advocated for lowering the cost of these medicines and building such programs since their launches. We remain the only group that publicly continues to challenge the pharmaceutical industry around this issue. See our statement here: https://www.obesityaction.org/wp-content/uploads/Statement-on-Drug-Pricing-for-Anti-Obesity-Medications.pdf

Lately, we’ve seen some our advocacy pay-off with Lilly and Novo both now offering direct to consumer pricing of around $500 per month but there is still more work to be done and OAC’s ultimate goals is to makes sure every insured person in the US has access to obesity medicines as a standard benefit covered by insurance (our advocacy on access is a fight we engage in everyday). We shouldn’t have to be paying out of pocket for these medicines! We also continue to strongly advocate with the Federal government to push the pharmaceutical companies to use their existing negotiating power under legislation to help us bring the prices to more reasonable levels. Those negotiations on semaglutide have just started and OAC is an active participant in that process.

FDA Ending the GLP-1 Shortage

For those of you directly worried about the upcoming end of the period where FDA allowed compounded GLP-1’s, I’d strongly encourage a conversation with your health care professional around the possibility of switching to a branded obesity medication. You might be surprised how close in price the branded medications are with the new cash-pay programs or some dosing adjustments. It’s also a good time to double check your insurance to see if you now have some coverage as many employers have added the benefit. I will say in my own care, my skilled obesity medicine professional guided me through a dosing regimen that let me achieve the benefits of a GLP-1 branded medications at near the same cost as a compounded medicine preventing me from ever having to try a compounded medicine. Skilled obesity medicine professionals can guide you through that process.

Final Thoughts

I know first hand the benefits of GLP-1’s. With that being said, it remains OAC’s strong position that compounded GLP-1’s aren’t the answer until they meet our long-standing criteria for evidence based, FDA approved care. Our real worry is 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 get maybe safe/maybe effective care through compounding if you can afford the more modest fees and if you don’t have great insurance and can’t afford the more modest fees, you get no care at all. We are advocating for a world where people don’t have to make those compromises and all have care.

My plea to anyone reading this is:

  • If you are currently using a compounded GLP-1, please make sure you are actively engaging with your healthcare professional so they can assess any unexpected impacts and make sure you are diligently reporting any adverse events.
  • If you are currently selling, marketing, producing and/or promoting compounded GLP-1’s, help us by being more transparent, giving us access to the information we need to make an evidence-based decision and working with us to weed out the bad players.