Is the shortage on GLP-1 weight loss meds really over?

OPINION:

I am an obesity medicine physician, and in the spring of 2024, I saw a patient for an initial visit who had heard about Zepbound, a popular name-brand GLP-1 weight loss medication produced by Eli Lilly. She was 60 pounds overweight and had tried everything to lose weight and get healthy. Over five years, she had developed high blood pressure and high cholesterol and was prediabetic. Most troublesome to her was the arthritis pain that prevented her from exercising to assist with weight loss.

Her insurance company covered Zepbound, but she could not find the medication in any pharmacy within a 25-mile radius of her home. For a patient like this, with prediabetes quickly evolving into diabetes and with troubling arthritis pain, waiting out the shortage of Zepbound wasn’t an option in my mind. Fortunately, we got her started on a compound of the same active ingredient, tirzepatide, while the Zepbound shortage was continuing.

Over nine months, this patient lost just over 60 pounds, her prediabetes had resolved, and she had been able to lower the dose of her blood pressure medication. The arthritis pain had improved so much that she was walking regularly and strength training. Last week, after the Food and Drug Administration ended the shortage of Zepbound and stopped allowing pharmacies to compound tirzepatide, she sought to find her maintenance dose of Zepbound at one of her local pharmacies. She was unsuccessful and understandably distraught.

As of March 19, pharmacies (specifically 503B compounding facilities) are no longer able to create compounds of tirzepatide. Patients can now access only the name brands of the medication. Since that time, I have continued experiencing Zepbound prescriptions being rejected when sent to mail-order pharmacies, and patients have had difficulty finding Zepbound at their local pharmacies. These stories are not isolated but widespread. They are not infrequent but have occurred daily. As a physician, I cannot help but notice that this drug could remain in shortage.

This begs the question: Was due diligence done on the part of the FDA to assure that Zepbound was truly readily available? And seeing that compounded medication has served a key role in filling the gap for estimated millions of patients affected by the Mounjaro and Zepbound shortages, dating back to December 2022, will there be adequate supply to continue to care for all of these patients as well?

I’ve prescribed compounded medications for thousands of patients seeking GLP-1 treatment for obesity during a time of brand name shortage, and I am deeply concerned with the ongoing difficulty my patients have in finding their medication. Moreso, I am concerned that the compounded medication that has been an alternative option for these patients needing to fill the gap is no longer on the table.

There has been a strong and convincing argument in the media and obesity medicine groups that compounded medications are the same as the black market, counterfeit GLP-1 knockoffs. This is not true, but this simplistic and unjustified comparison has driven fear into the public and medical providers alike. What we aren’t hearing about is how compounded GLP-1s are a safe, cost-effective alternative that has had a positive impact over the last two years for patients who would not otherwise have had access. While Zepbound has been on the shortage list, I have had patients on compounded tirzepatide lose over 100 pounds, resolve medical conditions like diabetes, and be able to fly on an airplane for the first time in decades. Why are we not talking about this? Why are we villainizing compounded medications and those who have prescribed them rather than acknowledging the tremendous positive impact they have had on both an individual and public health level?

Compounded medication has served a key role in filling the gap for estimated millions of patients impacted by the Zepbound shortage. I am gravely concerned that there will not be adequate supply to maintain continuity of care for these patients going forward. The newly confirmed head of the FDA, Dr. Martin Makary, is a doctor, just like me, who has sworn to prioritize the well-being of patients and “first, do no harm.” I urge him to pause enforcement action to look at all the solid evidence and clinical and public health implications of the decisions that preceded him, as we, as physicians, are trained to do. I am asking the FDA to put patients first.

• Dr. Jessica Duncan is an obesity doctor and chief medical officer of Ivim Health.