The U.S. Food and Drug Administration (FDA) is preparing to prohibit compounded versions of the popular weight-loss and diabetes drugs Ozempic and Wegovy, following the agency’s determination that the medications are no longer in short supply. The decision has sparked a legal battle and raised concerns about patient access and safety.
Why Compounded Versions Became Popular
Semaglutide, the active ingredient in Ozempic and Wegovy, was added to the FDA’s drug shortage list in 2022 after demand surged—partly due to off-label use for weight loss. To address the shortage, the FDA temporarily allowed pharmacies to produce compounded versions, which are not subject to the same rigorous approval process as brand-name drugs.
These compounded alternatives became a lifeline for many patients, particularly because they are significantly cheaper than the branded versions. With insurance companies often refusing to cover weight-loss prescriptions, compounded semaglutide offered an affordable option. Industry estimates suggest that around 2 million Americans have relied on these versions in the past year.
Legal Battle Over the Ban
Now that the FDA has declared the shortage resolved, it has ordered compounding pharmacies to stop producing semaglutide within 60 to 90 days or face enforcement action. However, the Outsourcing Facilities Association (OFA), a trade group representing compounding pharmacies, has filed a lawsuit to block the ban.
The OFA argues that the shortage is not truly over and that cutting off compounded versions will leave patients without affordable access. The case mirrors a recent dispute over tirzepatide, another weight-loss drug, where courts ultimately upheld the FDA’s decision to ban compounded versions. If the same happens here, the ban could take effect by mid-2024.
Safety and Access Concerns
The FDA has raised concerns about the safety of compounded semaglutide, citing over 450 reports of adverse events, including dosing errors and unregulated formulations. However, some experts worry that banning these versions could push patients toward riskier alternatives, such as unregulated online pharmacies or counterfeit drugs.
For now, patients using compounded semaglutide are advised to transition to FDA-approved versions where possible. But with brand-name drugs remaining expensive and insurance coverage limited, many may find themselves without a viable alternative. The outcome of the legal battle will determine whether compounded versions remain available—or if patients will be forced to navigate a shrinking pool of options.
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