Greetings,
Have you recently seen advertising for a GLP-1 drug? If so, you are one of millions of adults targeted by these ads of the increasingly popular class of prescription drugs for weight loss. 2023 data have shown that pharmaceutical companies have spent over $1 billion on advertisements for weight loss and diabetes medications, which is up 51% from the previous year. An increasing number of adults have said that they are now familiar with the new medications. Polling shows one in eight U.S. adults (12%) say that they have taken a GLP-1 drug, and 6% that say they are currently taking such medications.
The growing demand for GLP-1 drugs has led to a significant supply-demand imbalance, especially for highly sought-after obesity medications like tirzepatide and semaglutide. The increased demand and effective marketing campaigns have contributed to existing shortages impacting millions of patients across the country.
Due to the shortages of obesity medications, some patients are turning to pharmacies that produce compounded versions of these medications. Compounding is a legal process whereby licensed pharmacists create medications that are either not commercially available or are in short supply. In cases where a manufactured drug is not the best course of therapy for a patient, compounding can customize medications to meet specific patient needs, such as removing an allergen or creating a unique dosage requirement.
Over 300 major drugs in the U.S. are currently in shortage as of 2024, leaving patients with delays or a complete lack of access to these medicines. In situations of widespread shortages of FDA-approved medications, compounded alternatives may be the only option for many patients. The FDA allows the compounding of certain drugs if the commercially available version is in a verified shortage, which they define as “a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.” Although there is no exact threshold, this decision is usually based on disruptions in manufacturing and distribution as well as unexpected demand surges. A shortage is generally declared over if the FDA considers the drug to be commercially available.
Congress exempts compounded medications from FDA approval via Section 503A of the Federal Food, Drug, and Cosmetic Act. The FDA and state boards of pharmacy regulate compounding mainly categorized into two categories, 503A and 503B facilities. 503A compounding pharmacies, also known as traditional compounding, are designated as those that create medications for individual patients and must be based on specific patient prescriptions. These facilities are regulated by state boards of pharmacy and are required to comply to United States Pharmacopeia (USP) standards. 503B compounding pharmacies, also known as outsourcing facilities, are those that manufacture in bulk and without specific prescriptions to be distributed to healthcare facilities. These facilities are regulated directly by the FDA and must comply with Current Good Manufacturing Practices (CGMP), the same standards as traditional drug manufacturers.
Although compounding pharmacies must adhere to high standards of quality and comply with state and federal regulations, there are significant risks to patients. The compounded versions of tirzepatide and semaglutide sold by compounded pharmacies are not the same as the drug provided by the manufacturers. The FDA has stated that “compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.”
The Obesity Action Coalition (OAC), The Obesity Society (TOS), and The Obesity Medicine Association (OMA) have released a statement expressing their concerns for patients using the compounded GLP-1 alternatives. They warned thatsome formulations of these drugs have not been shown to be safe and effective and emphasized that they are not FDA-approved. Adverse reactions are possible and may pose a risk to patients. Patients should consult their healthcare providers and be informed about avoiding these risks.
Earlier this month, the FDA announced that the tirzepatide shortage was over after being in short supply since 2022. After Eli Lilly, the manufacturer of tirzepatide, determined that the supply was adequate and the shortage had ended, the FDA required compounding pharmacies to halt production and preparation of compounded tirzepatide. However, less than 2 weeks later, after intense public backlash and a lawsuit from compounding pharmacies, the FDA announced to the Alliance for Pharmacy Compounding that it would reevaluate their decision and not take action against pharmacies who continue selling the compounded version. And just this week, Novo and Lilly have asked the U.S. Food and Drug Administration to put semaglutide and tirzepatide on a list of drugs that are too hard for compounding pharmacies to make.
Lost in this conversation are the patients who have come to rely on the compounded versions of tirzepatide and semaglutide. Compounding offers a solution to drug shortages, and as demand for obesity medications continue to rise, conversations surrounding compounding will remain important. For now, patients are left navigating an increasingly complicated path with limited guidance about how to access these life-saving treatments.