Hims & Hers hit the bullseye with its Super Bowl ad, sparking a surge in clicks to its site.
The ad also hit a nerve with the pharma industry, lawmakers and some industry groups.
The ad, called "Sick of the System," aired in the third quarter of Sunday's Super Bowl LIX game, the most-watched Super Bowl ever with 127.7 million viewers, according to FOX Sports. The ad featured a montage of junk food, abdominal fat, statistics about the health risks of obesity and big pharma's high prices. The ad then promotes Hims & Hers' weight loss products, including compounded GLP-1 medications, as an alternative to pricey branded GLP-1s such as Ozempic and Wegovy.
"Junk food giants, diet industry’s quick fixes, Big Pharma’s price-gouging, and regulations that favor special interests have created a system that leaves us with limited options, skyrocketing costs, and a cycle of failure," Hims & Hers said on a site that promotes the ad.
"The Super Bowl ad did a great job of driving awareness about the Hims & Hers platform, our commitment to making healthcare more accessible and the options individuals have for weight management solutions," a Hims & Hers spokesperson said in a statement to Fierce Healthcare.
The company saw an "unprecedented" surge in engagement, with traffic spiking over 650% in the hours post-airing, according to Hims & Hers data that the company shared with Fierce Healthcare.
New customer registrations and platform activity hit record highs, "reflecting widespread consumer interest and demand," the spokesperson said. Case in point? The Hers app jumped to #2 in the Health & Wellness category on the Apple Store. The app was not in the top 10 prior the game, the spokesperson noted.
Also, according to data from EDO Inc., a platform that measures predictive behaviors driven by TV advertising, Hims & Hers' Super Bowl ad ranked #5 in engagement among all ads aired during the game.
Investors also liked what they saw as shares of Hims & Hers gained 10% this week and shares are up 83% so far this year.
But the controversial ad also garnered backlash from some viewers and caught the attention of the pharma industry, lawmakers, medical experts and patient advocacy groups, who lashed the company for "deceptive" advertising and for perpetuating a stigma on obesity.
Hims & Hers is a multispecialty telehealth platform that connects consumers to medical care for numerous conditions related to mental health, sexual health, dermatology and primary care. The company expanded into weight loss in late 2023 with oral medication kits and added compounded GLP-1 medications to its offerings last May. Hims & Hers also offers subscriptions for Wegovy and Ozempic, starting around $1,800 a month, while compounded GLP-1 medications are priced at $165 a month for a subscription.
Compounded semaglutide injections have the same active ingredient as the buzzy branded weight loss drugs but are not required to go through the Food and Drug Administration's rigorous approval process.
Because compounded medications are not FDA-approved, they do not carry standardized FDA required labeling, including side-effect warnings, boxed warnings, or risk evaluation and mitigation strategies (REMS) that apply to approved drugs. However, they are still subject to state board of pharmacy oversight and must comply with USP compounding standards and Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, according to the The Alliance for Pharmacy Compounding.
In June 2023, the FDA issued a warning that unapproved versions of GLP-1 drugs "can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed."
The GLP-1 drug market has been dominated by pharmaceutical giant Novo Nordisk. Demand for these drugs have soared in the past few years, sparking periodic shortages. The medications also are gaining expanded approval from regulators and increased health coverage.
When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Food and Drug Administration, the FDA said in a January release. The FDA said patients should not use a compounded GLP-1 drug if an approved drug, like Wegovy, is available.
Novo Nordisk, for its part, hit back almost immediately, placing an ad in The New York Times and USA Today on Monday called "Check Before You Inject."
A company spokesperson said the ad was a "direct response" the Hims & Hers Super Bowl commercial. The ad features a vial that reads "compounded semaglutide" and a syringe. "Some compounded semaglutide vials have been found to contain dangerous impurities, banned substances, or incorrect doses. Bottom line: If the label doesn’t say Wegovy (semaglutide) or Ozempic (semaglutide), it’s not FDA approved and you have no idea what’s inside," the ad reads.
"With this Check Before You Inject ad, Novo Nordisk is warning consumers about the significant dangers of reaching for illegitimate compounded 'semaglutide' drugs, which have been shown to contain impurities and ingredients dangerous to patients. The recent explosion in irresponsible and misleading advertising about compounded GLP-1 drugs, like the Hims & Hers Super Bowl commercial, puts patients’ safety at risk and we cannot stay silent," the company said in a statement to Fierce Healthcare.
In response to the Novo Nordisk ad, a Hims & Hers spokesperson said, "We take safety, quality, and transparency steps for every customer on our platform. That includes making Certificates of Analysis—a report card on quality standards for USP benchmarks—available to every GLP-1 customer, so they know the exact ingredients from FDA-regulated suppliers that are in the medications they receive."
The ad sparked controversy before it even aired on Sunday as it was available on YouTube in late January.
On Feb. 7, The Obesity Society said in a statement that the Super Bowl advertisement "will mislead viewers by excluding any information about the overall risks and side effects of compounded drugs. The ad emphasizes the role of the food and health system in the obesity epidemic and fails to include any specific information about the potential risks and side effects of Hims’ drugs being marketed to consumers."
The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing pharma companies, said the ad runs afoul of the Federal Food, Drug, and Cosmetic Act (FDCA), which requires that advertising for prescription drugs—including compounded drugs–not be false or misleading.
"It also resurfaces serious concerns about the lack of oversight of the compounding industry, specifically that these products don’t undergo the same extensive FDA review for safety and effectiveness. At the same time, the way these products are advertised and marketed violates the stringent requirements imposed on advertising for all products," PhRMA said in a statement.
Hims & Hers, through a spokesperson, said the company complies with existing laws and noted that compounding is explicitly permitted by the FDA and has been done safely with a high level of oversight from the FDA for decades.
The company also said it explicitly discloses that compounded medications are not FDA-approved or evaluated for safety, efficacy, or quality, ensuring transparency in its messaging.
In the Super Bowl ad, the disclaimer that its compounded medications aren't FDA-approved was displayed briefly and in a very small font.
The ad also garnered attention on Capitol Hill.
On Friday, U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Roger Marshall, M.D. (R-KS) sent a bipartisan letter to the FDA flagging Hims & Hers' ad and accusing the company of misleading patients "by omitting any safety or side effect information when promoting a specific type of weight loss medication."
Under federal law and regulations, FDA requires that prescription drug advertisements be truthful, not misleading, and balanced—failure to do so risks FDA enforcement action, including civil monetary penalties, Durbin and Marshall said in the letter.
The lawmakers said they "recognize the important roles that pharmaceutical compounding and telehealth play in the health care delivery system, helping to ensure access to FDA-approved products and filling a need for more customized treatments."
But they contend that the advertisement appears to be exploiting a perceived loophole in federal law regarding promotions of compounded drugs by telehealth companies, according to a statement from the lawmakers.
Durbin and Marshall said they plan to introduce legislation to close any gaps in regarding prescription drug advertising.
"We agree with Senators Durbin and Marshall on the value of compounding and telehealth when it comes to expanding much-needed access to personalized care. We are complying with existing law and are happy to continue working with Congress and the new Administration to fix the broken health system and ensure that patients have choices for quality, safe, and affordable healthcare," the Hims & Hers spokesperson said in a statement to Fierce Healthcare.
But the current political environment might be in Hims & Hers' favor. The ad notes that the company's compounded drugs are made in America, which might hit the right tone with the Trump administration. And Robert F. Kennedy Jr., who has championed a Make America Healthy Again platform and also has been critical of the pharma industry, is poised to become the next HHS Secretary.
Hims & Hers’ Chief Commercial Officer Mike Chi told The Wall Street Journal that the goal of the ad was “not only to talk to customers but to raise the issue among regulators, legislators, and those who can drive change.”
The Alliance of Pharmacy Compounders (APC) put out a statement in support of Hims & Hers' ad, noting that unlike FDA-approved drugs, which must comply with strict labeling requirements under the Federal Food, Drug, and Cosmetic Act, compounded medications have different rules for marketing and advertising. Compounded drug advertisements fall under FTC jurisdiction, not the FDA's typical prescription drug advertising rules, the organization said.
"Hims’ Super Bowl ad does not promote a specific drug or medication and therefore is not required to provide information about side effects or risks," APC said. "While the focus of Hims’ Super Bowl ad on drug pricing may push the envelope in terms of the role of compounded drugs in our healthcare system—a debate worth having—it’s also perfectly consistent with laws and regulations that allow companies to promote healthcare services without promoting specific drug or needing to make certain disclosures about certain drugs," APC said.
The clash over compounded GLP-1 medications comes as a new survey of primary care physicians finds that doctors are increasingly concerned about the risks of patients using third-party telehealth prescribers of GLP-1s for weight loss.
Two-thirds of PCPs (67%) said accessing GLP-1 prescriptions for weight loss through a third-party telehealth provider may put their patient’s health at risk, according to a survey of 2,000 primary care physicians on Sermo. The survey findings were released by Omada Health, a digital health company that targets chronic disease management.