#ReportTheShortage: Eli Lilly's Bold Move and Its Implications for GLP-1 Medication Access

This past week, Eli Lilly declared to the FDA that all dosages and strengths of Tirzepatide—branded as Zepbound for obesity and Mounjaro for diabetes—are now available from the manufacturer to distributors. This announcement marks a significant development in the ongoing struggle for medication accessibility. The FDA must now verify Eli Lilly's claim that all strengths and dosages are indeed available. If confirmed, the FDA could proceed with removing Tirzepatide from the master shortage list, a decision that will have profound implications for both 503A and 503B pharmacies.

If the FDA removes Tirzepatide from the master shortage list, 503B pharmacies will face dramatic changes. These pharmacies, which can skirt patents and manufacture drugs in mass quantities in response to the declared FDA shortages, will be granted a 60-day grace period to fulfill existing orders. After this period, the FDA will begin enforcing regulations on any 503B pharmacies that continue compounding these medications inappropriately.

In contrast, 503A pharmacies, which compound medications on a per-prescription basis, will receive no grace period. They will need to revert immediately to their standard practices, compounding medications only for patients with specific medical needs. This includes patients who have injection site reactions, intolerances to brand-name medication preservatives or dyes, and other similar issues. In other words, a patient would have to have a medical need that precipitated a compound version of the medication.

While Eli Lilly's announcement suggests that Tirzepatide is fully available, my extensive social media network—comprising about 75,000 followers (by and large users of GLP-1 medications)—tells a different story. Many individuals continue to report significant difficulties in obtaining their prescribed dosages of Mounjaro or Zepbound. Despite Eli Lilly's claims, patients are still experiencing shortages and disruptions in their treatment schedules. This discrepancy highlights a troubling gap between corporate declarations and patient experiences on the ground.

The current situation also appears to be influenced by competitive dynamics in the pharmaceutical and telemedicine sectors. Large telemedicine companies like Weight Watchers have recently shown interest in offering compounded versions of these medications. Eli Lilly's move to declare full availability may be a strategic response to these emerging market pressures.

The time for advocacy is now. Similarly to our continued call for Eli Lilly to #ReleaseTheVials, we are now calling advocated and On The Pen followers to use the hashtag #ReportTheShortage to ensure that the FDA is getting the patient side of the story in addition to the corporate declarations they are receiving. The FDA offers a tool for those to report their shortage experiences to the FDA. Additionally the telehealth company (and On The Pen sponsor) Ro offers a community tool called the GLP-1 Supply Tracker, which also reports shortages to the FDA, as well as provides email alerts when medications are found in your area.

Please share this article everywhere online that discussions about these medications are taking place. Together we can be loud. Together we can be heard. And together, we will fight for patient access to these life changing medications.