The Food and Drug Administration announced that a shortage of medications Wegovy and Ozempic has been resolved; however, companies like Hims and Hers might have to stop selling compounded versions of the drugs.
When the FDA declared a shortage in 2022, pharmacies were allowed to make compounded versions of the drugs to meet demand. These drugs use the same active ingredients, but Ozempic and Wegovy maker Novo Nordisk claimed this process put patients at risk. However, this also allowed pharmacies to offer these drugs at lower costs.
Hims and Hers noted that its products were not FDA-approved, but that did not stop customers from taking advantage of its offerings.
“Non-FDA approved compounded drugs claiming to contain semaglutide with high levels of known impurities and unknown impurities pose significant risks to patients and may lead to serious and life-threatening reactions,” said Doug Langa, executive vice president of North America operations at Novo Nordisk.
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Novo Nordisk brought numerous lawsuits against the FDA and companies selling compounded versions of the drugs. The FDA said companies have until May 22 to stop selling compounded versions of the drugs and stated that it could take legal action against companies that have sold unsafe copies of the drugs.
The semaglutide known as Ozempic is intended for people with diabetes. Drugmaker Novo Nordisk later got approval to market Wegovy, a semaglutide that has a different dosage, for weight loss.
Hims has sold one-month doses of GLP-1 semaglutides starting at $165 per month. The list cost of Wegovy is $1,349, and one dose is generally taken every four weeks.
Andrew Dudum, co-founder of Hims and Hers, says customers are starting to be notified of the changes.
"I would suspect we will have to start notifying customers in the coming month or two that they will need to start looking for alternative options for the commercial dosing," he said. "Obviously, we have the expansive platform, whether it's the oral medications that are already out there or if there is some reason that this patient would qualify for some level of personalization that exists. But I would suspect, just being very direct, that a lot of those patients will try to go into the open market and try to secure a branded option in some form factors. So, that transition is inevitable."
Yemi Okupe, chief financial officer of Hims and Hers, said compounded weight loss drugs brought in $225 million in revenue for the company in 2024 after the company began selling the products last spring.
Although Hims and Hers expects to no longer be able to sell GLP-1 products, it will continue offering oral weight loss medication as a cheaper alternative.
"Consumers are very motivated to lose weight and have a holistic platform to do so," Okupe said. "We also know that consumers are looking for health and treatments from platforms that they trust. So, those are the elements being one of the reasons why the oral weight loss was able to scale so quickly. We see continued momentum even when we had personalized or compounded commercially available dosages of semaglutide on the platform."
Medications like Wegovy are known as GLP-1 agonists, and many of these drugs were initially prescribed to manage Type 2 diabetes but have since gained popularity for helping patients manage weight. According to the Cleveland Clinic, these medications help manage blood sugar levels by triggering insulin release from the pancreas. The drugs also help slow digestion, which causes less glucose to enter the bloodstream. Additionally, the medicine also affects satiety, allowing patients to feel full after eating, according to the Cleveland Clinic.
