FDA Declares End to Semaglutide Shortage, Sparks Concerns Over Access to Affordable Weight-Loss Drugs
The Food and Drug Administration (FDA) announced on February 21 the resolution of the semaglutide shortage, a decision that may limit access to cost-effective weight-loss medications for many Americans.
Semaglutide, the key component in the injectables Ozempic and Wegovy, is utilized to manage obesity, diabetes, and other health conditions.
During the shortage, compounding pharmacies were able to provide semaglutide, producing medications tailored to individual needs rather than in bulk, often reducing costs by 70% to 90% compared to branded versions.
The FDA did not provide specific reasons for ending the shortage. However, the decision followed comments from Eli Lilly CEO Dave Ricks, who told Fox Business on February 13 about his efforts to influence the White House to limit compounded semaglutide’s availability.
Ricks remarked, “Compounding sounds like a nice word, but really these are using intellectual property that we developed, taking our invention, and buying unapproved active ingredient — mostly from Chinese labs that aren’t even approved in China — importing it and selling it to Americans at a discount. That’s not real medicine. That’s fake medicine and we think that should stop. Our advocacy with the FDA and the new administration is to shut that down.”
Ricks’ assertions are not entirely correct. The Danish pharmaceutical company Novo Nordisk originally developed semaglutide. Eli Lilly’s creation, tirzepatide, is the active ingredient in their product, Mounjorno.
Although compounding pharmacies often acquire semaglutide from Chinese firms, these suppliers are mandated to register with the FDA.
Ricks has also advocated for weight-loss medications like Mounjoro to receive Medicare and Medicaid coverage. Without compounded alternatives, such coverage could result in substantial federal funding for Eli Lilly.
The decision to lift the shortage has also raised conflict of interest concerns involving Dr. Mehmet Oz, the forthcoming administrator of the Centers for Medicare and Medicaid Services.
In 2019, Oz dedicated 20 minutes of his talk show to discussing Ozempic, a Novo Nordisk product, amidst a promotional contract between his media company and Novo Nordisk. He continued advocating for Ozempic on his website and social media platforms as recently as last year.
Novo Nordisk has similarly lobbied for their weight-loss drugs to gain Medicaid and Medicare coverage.
Following the FDA’s declaration, Novo Nordisk’s U.S.-listed shares jumped 6.2%, while Eli Lilly’s stock rose by 3.2%.
In response, a coalition of compounding pharmacies filed a lawsuit against the FDA on February 24 to challenge the decision. A federal judge has yet to determine the case’s progression.
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