Oct 26, 2024
Novo Nordisk is urging the U.S. Food and Drug Administration (FDA) to block ‘copycat’ versions of its popular weight-loss and diabetes drugs, arguing that the complexities of manufacturing these treatments make them too risky to replicate safely.
The drugs Ozempic and Wegovy are injections created to help manage blood sugar in people with Type 2 diabetes. Recently they have gained popularity as an off-label treatment for weight loss.
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However, with demand for these drugs surging, affordability has become a major issue. According to recent KFF survey data, nearly 1 in 8 U.S. adults have used a GLP-1 drug like Ozempic, with over 15 million Americans currently holding prescriptions. Yet, more than half of those users report that the cost is difficult to manage.
Novo Nordisk is facing some heat from Senator Bernie Sanders, who publicly challenged the company in a letter, accusing it of charging U.S. patients up to 15 times more for Ozempic and Wegovy in other countries.
“For example, your company charges $969 in the United States for one month of Ozempic but just $155 in Canada and just $59 in Germany,” Sanders wrote.
While Novo Nordisk pushes for a ban on copycat versions, it raises the question of whether this move could hinder efforts to make the drug more accessible to Americans.
What is Novo Nordisk really asking for
Novo Nordisk is asking the FDA to crack down on unapproved, cheaper versions of weight loss drugs. But in the U.S. health care system, compounding pharmacies have long filled supply gaps for essential medications, including cancer treatments like cisplatin.
Often operating as nonprofits, these pharmacies provide more affordable alternatives when branded drugs are unavailable or too expensive. Compounded medications differ mainly in that they lack FDA approval and don’t undergo the same rigorous testing required for branded drugs.
“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits,” Novo Nordisk wrote in a statement.
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For some patients, however, compounded versions are the only affordable option. With high drug prices and insurance plans often not covering weight-loss treatments, many turn to compounded alternatives.
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Prioritizing health or protecting profits?
As Novo Nordisk intensifies its efforts to halt the compounding, questions arise about the true motivation behind its push. While the company says patient safety is its primary concern, critics argue the move may be more about protecting profits.
For Jennie Smith, a seamstress in Ohio, Wegovy’s $1,000 monthly price tag made it inaccessible. After researching, she found a compounded version through an online pharmacy, paying just $300 a month instead. While the key ingredient remains the same, this compounded version was produced by a pharmacy, not a pharmaceutical giant like Novo Nordisk.
Scott Brunner, CEO of the Alliance of Pharmacy Compounding, questioned why it took Novo Nordisk two and a half years to raise concerns about compounded versions.
“Novo Nordisk is so deeply concerned about patient safety that it’s taken them a whopping two-and-a-half years while their drug has been in shortage to conclude that the semaglutide API is so demonstrably difficult for compounding pharmacies to prepare that FDA now needs to place it off-limits for compounding?” Brunner wrote in a statement.
With the FDA’s upcoming decision, the accessibility of affordable alternatives hangs in the balance, potentially reshaping the future of weight-loss treatments and patient options.
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Victoria Vesovski is a Toronto-based staff reporter at Moneywise covering personal finance, lifestyle and trending news. She holds degrees from the University of Toronto and New York University, and her work has appeared on platforms including Yahoo Finance, MSN Money and Apple News.
