The U.S. Food and Drug Administration is evaluating whether to take Wegovy off its shortage list, which currently permits compounding pharmacies to create versions of the drug for patients who cannot find or afford it. Compounded alternatives are often cheaper and have become a viable option for many Americans amid supply challenges.
The compounding industry's letter to the FDA highlighted that prescriptions for Wegovy are currently four times greater than those for compounded versions. This suggests a strong continued interest in Novo's drug, even as compounding pharmacies fill critical gaps for patients needing access.
Novo Nordisk stated it prioritizes ensuring that patients receive safe and effective treatments, emphasizing the risks associated with compounded drugs, which are not FDA-approved. The company has asked for an exemption from FDA regulations that govern compounding to better align with patient needs.
The FDA acknowledged the significant demand for semaglutide and its ongoing assessment of whether announced supply levels will be sufficient to meet patient needs, recognizing the importance of compounded drugs while warning about their unapproved status.
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