The Most Dangerous Commercial Of All Time?
As one of the many households that has cut the cord on cable and relied primarily on streaming services for my entertainment, I am mostly spared from viewing the traditional television commercial. On the rare occasion I watch a live event like the Super Bowl, I put on my game face and brace for the onslaught of advertisements that corporations spend millions of dollars on to try to sell me a product, idea or message. I generally make it through unscathed, but this year there was one commercial in particular that caught my attention and generated an emotional response, but not it a good way. Ladies and gentlemen, I am referring to the Hims & Hers commercial hawking their compounded GLP-1 medication.
Now, maybe it was because I was the only pharmacist in the room, but no one else I was with seemed to bat an eye at what was being promoted on the screen. I knew that GLP-1 medications were being compounded and sold to patients as a way to provide access while their Commercial counterparts were in short supply, but I had no idea just how much this practice had ballooned. Never in my wildest dreams did I ever think I’d be seeing advertisements for a compounded medication, let alone on National television, let alone the Super Bowl!
So, what is it that rubs me the wrong way about this? I won’t get into the messaging behind the ad, as I may have to dedicate an entire podcast to how I feel about that. My major concerns are how the company appears to be skating a fine line between what is legal and what is ethical when it comes to compounding pharmaceuticals and marketing them.
I want to be clear that this is not a dig on compounding. I believe compounding can play a significant role in treating certain patients. During my time as a hospice pharmacist I saw first hand just how essential compounding could be. We prepared and dispensed hundreds of compounded medications every day. Our patients greatly benefitted from unique dosage forms that didn’t exist commercially, in order to help meet their specialized needs. This included formulations such as highly concentrated solutions should swallowing become difficult, as well as various topical combinations to treat a variety of symptoms at end-of-life.
This type of compounding falls well within the regulatory guidelines for compounding under the FDA and United States Pharmacopeia (USP). Now, compounding a commercially available product, which is what Hims & Hers is doing, isn’t technically illegal but I believe the way they are going about it is questionable.
Under the current guidelines, compounding a commercially available product is generally restricted but can be allowed under specific circumstances such as drug shortages. If the commercially available product is on the FDA’s drug shortage list, compounding may be permitted to ensure patient access. This is where companies like Hims & Hers are justifying their actions.
This is the first instance I can think of, however, where a commercially available product is being compounded despite the manufacturer of that product having exclusive rights to market and distribute the drug. A scenario that has sparked a fierce legal battle between Novo Nordisk and companies like Hims & Hers over the unauthorized distribution and marketing of semaglutide, essentially fighting to protect their exclusive rights to the drug.
Novo Nordisk is the sole manufacturer of FDA-approved semaglutide medications. You know them as Ozempic (launched in 2017), indicated for diabetes, and Wegovy (launched in 2021), indicated for weight loss. In August of 2022, FDA declared a shortage of semaglutide due to unprecedented demand exceeding manufacturing capacity. I should also call out that being on the shortage list is not synonymous with being unavailable. Ozempic and Wegovy are still technically available, though it could be hit or miss on whether or not a pharmacy has them in stock.
That said, in a recent earnings call Novo Nordisk indicated that sales of Wegovy had more than doubled from Q4 2023 to Q4 2024. Regardless, Ozempic and Wegovy are still not considered to be at an “adequate” supply, and are likely to remain on the shortage list at least through 2025. Before being removed from the list they must demonstrate to FDA that there is a consistent and reliable supply that meets current demand (i.e., the drug must be readily accessible to patients nationwide without any supply concerns).
Seeing an opportunity to capitalize on the GLP-1 craze, Hims & Hers began offering compounded semaglutide in May of 2024. And business has apparently been booming as they have seen their stock price increase by nearly 300% since that time. I find this ironic as one of the messages from their Super Bowl commercial had to do with the demonization of pharmaceutical companies such as Novo Nordisk, underscored by the statement “Profits Over People”.
Ok, “so what’s the big deal?”, you may be asking. “They are simply taking advantage of the current situation and filling an unmet need, right?” I would say that is only partially correct. Because Hims & Hers is a “Telehealth” operation, I believe there are less than ideal practices being conducted to ensure a patient ends up with their compounded medication.
There are no in-person appointments or face-to-face interactions of any kind. Rather, one simply fills out an intake form and, after answering a few more questions from a doctor (via virtual chat), patients can expect to see their medication delivered to their door soon after. While this certainly sounds much more convenient than traditional physician encounters, I can’t say it is the safest or ideal way to diagnose, manage, and treat a patient. This is especially true when dealing with a cardiometabolic condition such as obesity, where a comprehensive and patient-centered approach are critical to one’s success.
There are no physical examinations or labs drawn. Not to mention the fact that there are no vitals being taken by the provider such as height and weight, which are essential in calculating a patient’s body mass index (BMI), which is then used to help assess the appropriateness, risks and benefits of prescribing a medication like sematlutide for weight loss. This is essentially a way to guarantee anyone that wants to take the medication, irrespective of their current health status and weight, can do so. I find this to be quite alarming. These are drugs after all, they are not benign substances that carry no potential for harm.
Let’s also not forget that compounded medications such as what Hims & Hers is marketing do not undergo FDA’s review for safety, effectiveness, and quality, potentially putting patients at risk. Additionally, Ozempic and Wegovy are dispensed in pre-filled, multi-dose pens. Each injection delivers the exact dose prescribed for a patient. Each dose of compounded semaglutide must be manually drawn into a syringe, which introduces the risk of complications from dosing errors associated with patients measuring and self-administering incorrect doses of the drug.
I would have to say, however, that my biggest concern with their commercial is the fact that it is completely void of any disclaimers about the potential risks of treatment with the products they are marketing. Traditional pharmaceutical manufacturers have a host of laws they must comply with when publishing advertisements for their products. They must include safety information about the drugs they advertise such as:
The drug’s most significant risks
Who should not take the drug
When the drug should not be taken
Possible serious side effects
Frequently occurring, but not necessarily serious, side effects
The Hims & Hers ad conveniently omits all of this, instead it simply offers its products as a solution to a problem. In doing so it grossly misleads the public and, in my opinion, violates the many laws in place for marketing drugs. If they are going to play the game, they need to abide by the same rules as everyone else.
If I was pressed to come up with any positives to the Hims & Hers model, I would have to say that it is affordability. According to their website, patients can get compounded semaglutide for as little as $165 per month. To qualify for this price it requires paying for a 12 month subscription up front and in full (so essentially one annual payment of $1,980). When looking solely at the numbers that is an attractive offer given that the cost of Wegovy is set at around $1,300 per month.
Keep in mind, however, that Hims & Hers paid nothing to research and develop compounded semaglutide, nor any of the other products they market. This gives them a distinct advantage over traditional drug manufacturers. For a company like Novo Nordisk to successfully bring a product to market it costs on average between 2 to 3 billion dollars. They then have, on average, 5 to 7 years of market exclusivity to recoup those expenses and turn a profit.
I believe that the pharma industry should be compensated for the work they are doing, but the extent of that compensation is one of the primary reasons they tend to get such a bad rap. For example: despite being in short supply, Wegovy managed to bring in over $2.7B in sales in Q4 2024 alone. I think it is safe to say they are in no danger of taking a loss on this product.
So, where do we go from here? Once semaglutide falls off of the FDA shortage list compounding pharmacies will be required to cease the production of compounded semaglutide. Historically, FDA has provided a grace period to allow for an orderly transition (e.g., 60 to 90 days, to discontinue compounding the drug). That said, Hims & Hers have already made comments that they have no plans of stopping their practices when the shortage is over. Now that they’ve wet their beak they want more.
They argue that because they “personalize doses and alter drug formulations” they can continue to sell compounded semaglutide indefinitely as it is not the same thing as commercially available semaglutide products. It reminds me of that time Vanilla Ice had the brass to claim that the main melody to his song “Ice Ice Baby” was not a knock off of “Under Pressure” by David Bowie and Queen.
I think we can all agree that whatever happens this isn’t going to end quietly and without a fight. We can expect things to drag out in court for a long time.
If you’ve made it this far, thank you for your time and attention. I truly appreciate you. I’d love to get your thoughts on this topic. Am I way off? Do you agree? Any additional talking points to consider? Let me know by commenting below, and I’ll see you on the next one.