The Food and Drug Administration (FDA) has ordered the phase-out of off-brand versions of Eli Lilly's popular weight-loss medications Zepbound and Mounjaro, signaling the end of their recent shortage and raising questions about access and pricing for patients dependent on these treatments. The announcement, which came this week, indicates the agency's judgment is based on Lilly's ability to meet or exceed the current demand for these drugs.
For patients struggling with obesity, this decision could have significant repercussions. Tirzepatide, the active ingredient found in both Zepbound and Mounjaro, has garnered attention for its impressive efficacy, enabling users to lose up to 25% of their body weight. The FDA's directive gives businesses 60 to 90 days to remove knockoff versions from the market, which are often significantly cheaper than the branded drugs.
The FDA articulated concerns over safety associated with compounded versions of these drugs, which have flooded the market during the shortage. "This decision is a win for Lilly," stated the FDA, reflecting on the pharmaceutical giant's months-long push for action on the issue.
Before this ruling, compounded versions of tirzepatide were very attractive to consumers, priced at around $250 to $350 monthly. This sharply undercut the list price for Zepbound, which stands at over $1,059. During the downtime of Lilly's branded products, telehealth and compounding pharmacies filled the void, providing customized medications to users who found the off-brand options more financially feasible.
The safety concerns raised by the FDA are not unfounded. Compounded pharmacies operate with fewer regulatory oversights than traditional manufacturers. Last year, the FDA flagged various issues with ingredients and formulations of some compounded GLP-1 drugs sold online. For people managing their weight with these medications, the risks tied to unapproved drugs could discourage their pursuit of treatment.
Despite the FDA's ruling, many patients may be left with fewer affordable options. Ted Kyle, a health expert with years of experience, voiced concerns, stating, "People are concerned. They're saying, 'This has been life changing but I don't have $1000 to pay out of pocket and my insurance isn't going to cover it.'" This sentiment resonates with numerous users who have come to rely on lower-cost compounded versions to manage their health.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, expressed similar frustrations with the FDA's decision. He indicated through his Linked-In statement, "The drugs they are advertising are not yet available in quantities to meet demand. Until they are, state-licensed pharmacies will continue to prepare compounded copies to provide patients access to life-changing medications."
Though Eli Lilly did not immediately respond to inquiries following the announcement, the decision raises pressing questions. How will this impact the booming telehealth industry, which has made strides by pairing individuals with medications? Some telehealth companies have already adjusted operations. For example, Henry Meds and Hims have begun removing compounded tirzepatide from their websites, as they adapt to the changed regulatory constraints.
Despite these challenges, drugs such as Wegovy and Ozempic from Novo Nordisk are still considered to be on the FDA's shortage list. This may provide some solace for patients seeking alternatives, as they deal with the new pricing realities driven by the return to brand names.
Interestingly, there’s more news on the horizon for GLP-1 drugs. On December 24, the FDA announced the approval of the first generic version of a once-daily GLP-1 injection aimed at Type 2 diabetes. This could lead to the introduction of similar generic medications for weight loss and potentially shift the dynamics of cost and access.
For now, many individuals seeking weight loss medications find themselves caught between the rising costs of branded drugs and the dwindling availability of lower-cost alternatives. "This is going to be a continuing tension for years to come," noted Kyle, adding, "Maybe compounding will go away but the issue won't go away because the pricing does not match the scale of need."
While the future of GLP-1 drugs such as tirzepatide appears more stabilized, its latest developments place both patients and healthcare providers at the center of challenging decisions about medication access and affordability.
