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The drug-maker cited concerns over deceptive marketing and the selling of compounded GLP-1 medications.
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The popularity of GLP-1 medications for weight-loss made these drugs difficult to obtain when they initially hit the market. Over the past two years, drug makers and suppliers have worked diligently to improve the supply chain and ensure that patients who need the medication are able to get it. The situation provided an opportunity for drug compounders to fill the gap.
However, companies like Novo Nordisk have raised concerns when it comes to compounding. For drugs as popular as GLP-1s, there is a risk that some compounded drugs may not be safely produced. Novo Nordisk has been outspoken in its efforts to promote the use of officially produced medications to ensure safety.
As such, Novo Nordisk ended its collaboration with Hims & Hers over concerns of illegal mass compounding and deceptive marketing.1 In a statement, Novo states that it conducted an investigation into the production of mass compounded semaglutides and found that many of the drugs offered by telehealth services are manufactured by suppliers in China.
The investigation also reportedly found that the sites used to manufacture these drugs have not been inspected or approved by FDA.
Hims & Hers customers will no longer have access to Wegovy through the company’s services.
In a press release, Novo Nordisk’s executive vice president of US operations Dave Moore said, “Novo Nordisk is firm on our position and protecting patients living with obesity. When patients are prescribed semaglutide treatments by their licensed healthcare professional or a telehealth provider, they are entitled to receive authentic, FDA-approved and regulated Wegovy®. We will work with telehealth companies to provide direct access to Wegovy® that share our commitment to patient safety––and when companies engage in illegal sham compounding that jeopardizes the health of Americans, we will continue to take action."
In May of this year, FDA ended a grace period that allowed mass compounding of semaglutide that had been put in place combat shortages.2 As the supply of officially produced medication stabilized, FDA removed the broad exception.
In a press release issued at the time, Moore said, “Mass compounding of 'semaglutide' is illegal, dangerous, and must stop now, which is why we are doubling down on our commitment to accessibility, availability, and affordability of authentic, FDA-approved Wegovy®. Novo Nordisk always puts patient safety first, and we urge all stakeholders, including the FDA, Boards of Pharmacy, and law enforcement, to take decisive action to uphold the highest quality standards of care."
Also in May, Novo Nordisk announced that FDA accepted its filing application for oral semaglutide, which could become the first oral GLP-1 treatment for obesity.3
In a press release, Novo Nordisk’s senior vice president of clinical development, medical and regulatory affairs Anna Windle, PhD, said, “"We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations. Novo Nordisk's strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment. We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity."
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