A Super Bowl commercial put out by the telehealth company Hims & Hers is drawing heat from critics who say the company’s promotion of its weight-loss drugs misled consumers by leaving out key information.
At the center of the controversy are so-called compounded medications, which aren’t regulated in the same way as brand-name or generic drugs are and aren’t formally approved by the Food and Drug Administration (FDA).
In an ad spot that positioned Hims & Hers against “Big Pharma” and a system “leaving Americans sick and stuck,” the company advertised itself as a service offering inexpensive GLP-1 agonists or semaglutides — the class of medications that includes Ozempic and Wegovy. The brand-name versions of these medications are FDA-approved to manage Type 2 diabetes and obesity, as well as related conditions like cardiovascular disease.
Hims & Hers offers compounded versions of these drugs, which are not FDA-approved.
It took an eagle eye to spot that disclaimer on the Hims & Hers ad, however, as it was printed in small white font on a gray background. The ad also did not follow a practice required for FDA-approved medications, which is listing possible side effects of the drugs and contraindications — meaning medical conditions or treatments that might prevent a person from using the drug safely.
That’s a problem, according to critics.
“By mass marketing and mass producing compound medications, we are devolving the safety of our drug supply,” said Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines, a nonprofit coalition of stakeholders in the drug supply chain, from manufacturers to wholesalers to patient advocates. “We’re not having a debate about it, and we’re not even educating Americans about it.”
What are compounded drugs?
It’s a common misconception that what clinics like Hims & Hers sell — at a fraction of the cost of branded pharmaceuticals — are generic versions of drugs. But compounded medications aren’t generics, which must be manufactured with the same ingredients and by the same processes as brand-name pharmaceuticals.
Instead, compounded drugs are manufactured with the same active ingredients as generics and brand-names, but without the same regulations to control their production and labeling.
There are two places where compounded medications are made. The first is in small or neighborhood pharmacies, where pharmacists can customize small batches of drugs for patients with special needs. This is why compounded medications exist, Safdar told Live Science: A pharmacist may need to make a medication that is in shortage, or might need to somehow modify the “official” version of the drug. For example, they might make a liquid version of a drug only available in pill form for a patient who can’t swallow pills, or they might replace a non-active ingredient for a patient with an allergy to it. These pharmacies are regulated under state pharmacy boards.
Compounded drugs can also be made in what are called bulk outsourcing facilities, some of which are very large. These facilities are inspected by the FDA for safety, and manufacturers must buy their ingredients from FDA-approved suppliers. But the resulting drugs and the process by which they are made aren’t clinically tested, which is why the resulting drugs are not FDA-approved.
They are also not subject to the same supply-chain tracking as FDA-approved drugs are. Any FDA-approved medicine, whether generic or branded, has a unique serial number that links it back to its manufacturer. Compounded medicines don’t fall under this requirement.
“A big problem, if a compounding facility makes you a drug that was prescribed by a doctor you’ve never met in person, is you’re now holding a vial you’re expected to inject into yourself and there’s actually no way to know where it came from,” Safdar said.
If there’s a problem, it’s more difficult to pinpoint who’s liable, and more challenging to investigate if more users of the drug might be impacted. Track-and-trace also prevents counterfeit drugs from entering the system.
Looser labeling requirements for compounded versions of GLP-1s can also lead to confusion about dosage, according to an FDA alert issued in July 2024. The agency had received reports of patients being hospitalized after accidental dosing errors with compounded weight-loss drugs. There have also been alarms about compounding pharmacies using different versions of the active ingredients in these medications, leading to adverse events.
Compounded medications have led to tragedy before. In 2012, unsanitary conditions at a compounding pharmacy caused a 20-state outbreak of fungal meningitis that killed 64 people and infected nearly 800 others.
Related: Childhood obesity should be treated early and aggressively, new guidelines say. Is that safe?
‘Fair balance’
Hims & Hers uses compounded semaglutide only from FDA-regulated bulk outsourcing facilities, said Dr. Craig Primack, the company’s senior vice president of weight loss. Patients can check the testing related to their batch of medication on the company’s app, Primack told Live Science.
This testing covers bacterial and viral contamination, impurities, and whether the concentration of the drug is correct. Primack said that because Hims & Hers is not a drug manufacturer, the company is not subject to the FDA’s doctrine of fair balance, which requires that product advertisements include information about risks and side effects alongside benefits. Patients get that information during the consultation and prescription process, he said.
However, the idea that providers of compounded medications don’t have to list side effects or risks has gotten pushback from Senators Riachard Durbin (D-IL) and Roger Marshall (R-KS). They wrote a letter to the FDA Friday (Feb. 7) expressing concern that the lack of fair balance is a loophole for those selling compounded medications.
“To the extent this falls within a regulatory loophole for the FDA’s authorities, we plan to soon introduce bipartisan legislation to close this gap,” Durbin and Marshall wrote.
Companies like Hims & Hers are allowed to offer compounded versions of Ozempic and Wegovy because the brand-name drugs are in shortage and have been for years. For consumers, it’s an appealing option: The company offers brand-name Ozempic for $1,799 a month, out of pocket, while their compounded semaglutide starts at just $165 a month.
But compounding was never meant to provide a cheaper, mass-market version of FDA-approved medications, Safdar said. Nor were patients ever meant to have to navigate the difference, he emphasized.
“We need compounding,” Safdar said. “But the rules were designed [the way they were] because no one ever thought we would have wide-scale usage of these medications.”
The Hims & Hers Super Bowl commercial signals a potential shift in this status quo — one that may soon get its moment for debate if Durbin and Marshall’s bill moves forward.
This article is for informational purposes only and is not meant to offer medical advice.
