Ozempic Users Found a Workaround. Its Manufacturer Is Pissed

Lifestyle

Ozempic. Rybelsis. Wegovy. They’re three of the most popular semaglutide drugs on the market, but there’s one company behind them: Novo Nordisk. But in addition to the drug brand being a major player in the pharmaceutical world, Novo Nordisk is also the force behind a significant legal push to prevent semaglutide knockoffs in the U.S. They created a fan base desperate for their medication. Now, they have to get people to only buy it from them.

First released in 2018, semaglutide is a medication that mimics the GLP-1 hormone, regulating the body’s sugar levels, and decreasing the appetite. While the drug was developed and originally approved for diabetes patients, its side-effect of appetite suppression quickly made it a desirable option for weight loss. By early 2023, the Ozempic craze was born — with the drug becoming an award show punch line, constant tabloid rumor, and difficult to get even for actual diabetes patients. But as prices rise and demand far outpaces production, patients have taken to telehealth companies and compounding pharmacies, who provide drugs mixed and tailored by a pharmacist but not manufactured by name-brand companies. Now, the company is asking the courts to step in to prevent copycats. Novo Nordisk says they want their patients safe. Their patients have said they just want their drugs. 

According to five lawsuits reviewed by Rolling Stone, representatives for Novo Nordisk claim that alternative health organizations (like med spas and compounding pharmacies) are illegally selling what they call semaglutide, which constitutes a trademark infringement. According to both the company and the FDA, Novo Nordisk is the only U.S. company with FDA-approved semaglutide. Since there is no approved generic version, Novo Nordisk is arguing that anyone who sells semaglutide is in violation of state regulations against untested medications. They are also claiming that using the namebrands Ozempic or Wegovy in marketing material violates copyright law. In the three most recent complaints filed in July, Novo Nordisk claims Florida businesses WellHealth Rx, TruLife Pharmacy, Brooksville Rx, and Tennessee’s DCA Pharmacy all illegally offer their patients a product they say is semaglutide — and are allegedly putting patients at risk. (Defendants WellHealth Rx, TruLife Pharmacy, Brooksville Rx, and DCA Pharmacy did not respond to Rolling Stone‘s request for comment.) Novo Nordisk is requesting a stop to all alleged false advertisement, trademark infringement, and compounded semaglutide products from these businesses.

“Federal and state law require approval for new drugs for good reason. Drug approval is evidence-based, and it is essential to ensure the quality, safety, and effectiveness of new drugs,” the legal complaints read. “When companies circumvent the drug-approval process, safety and efficacy are, at best, unknown. The danger is not merely theoretical, as manufacturing and distribution of unapproved new drugs of unknown quality has endangered or adversely impacted public health.”

In a press release shared with Rolling Stone, a spokesperson for Novo Nordisk said the company is focused on legal action to keep patients safe, as they believe generic attempts at semaglutide have “created a high risk of consumer confusion and deception as well as potential safety concerns.”

“Compounded products do not have the same safety, quality and effectiveness assurances as our FDA-approved drugs and may expose patients to health risks,” the release says. “Novo Nordisk cannot validate the safety or effectiveness of products claiming to contain semaglutide that are not one of our own branded products.”

In June, the FDA also warned they’d received reports of patients taking the compounded version of Ozempic with “adverse effects” — but did not give any additional or specific information about the kind or intensity of side effects people had. The FDA also noted people could be using doses of semaglutide that are derived from a salt — which hasn’t been tested — rather than its pure form. 

But even a federal warning about potential reactions hasn’t done much to deter people desperately seeking the medication. In fact, in a June report, several patients told Rolling Stone that as long as prices remain high, they’ll continue to use workarounds to get their Ozempic, Wegovy, and Rybelsis.

Compounding pharmacies have long served as a necessary part of the U.S, pharmacy system. Compounding combines, mixes, or alters two or more ingredients to create a custom-tailored medication. It’s most commonly used for patients who might have an allergy to an ingredient in a name-brand product or need it in a different form, like a liquid instead of a pill. Rather than skip the medication altogether, a compound pharmacy will make them their needed medication, sans the allergen or offending distribution method. Compounded drugs are not FDA-approved but the agency does acknowledge that they “can serve an important patient need,” as long as patients avoid unnecessary use. And the FDA also allows compounded medications when a drug has been on the FDA shortage list. Semaglutide has remained on the FDA shortage list since 2022. 

“Shortage drug compounding is allowed to assure that patients can continue to access medications that in their physician’s judgment are necessary for them,” Scott Bruner, the Chief Executive Officer of the Alliance for Pharmacy Compounding, a compounding advocacy group, said in an emailed statement to Rolling Stone.

So in patients’ eyes, if it’s safe for life-threatening allergies, why not weight loss? 

“I read the FDA statement, but it was very blank. Tell me why I shouldn’t use it,” compound user May West previously told Rolling Stone. “Tell me someone got cancer and died from taking this. Otherwise, what are my other options?”

These aren’t Novo Nordisk’s first lawsuits regarding Ozempic. The company has been filing complaints surrounding trademark and copyright infringements since its semaglutide products were first released — and has said it will continue to do so if it means keeping patients safe. But there’s also a financial component. Trademarks cost money, and when someone buys a generic version of semaglutide, that money doesn’t go to Novo Nordisk. 

Trending

“Testing new drugs and obtaining the legally required regulatory approval to sell them are time-consuming and very costly. Ignoring drug-approval requirements provides Defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk,” the three most recent complaints read. “Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.”

But even if these legal actions are successful, they won’t impact the thousands of other compound pharmacies operating across the country, each with their standards set by their specific state of residence. And throughout Ozempic’s rise, patients have made it clear that if they have to choose between the drug they love and the company that made it possible, the drug always wins. 

Products You May Like

Articles You May Like

Supreme Court strikes down federal ban on bump stocks – NBC Los Angeles
10-year Treasury yields slip as traders digest drop in wholesale prices
Rising Hypes Premiere With Perfect Rotten Tomatoes Score
Premiere Date, Cast & Everything We Know So Far
LANY’s Paul Klein Recovering After Being Hit by Car, Reschedules Tour