Janet Jackson’s infamous wardrobe malfunction may soon become the second most consequential Super Bowl off-field moment of the 21st century. A minute-long ad from telemedicine giant Hims/Hers has sparked bipartisan calls for regulatory review that may send shockwaves through the healthcare system.
The company warned Super Bowl viewers that “America’s deadliest epidemic” could only be solved if viewers purchase its “affordable, doctor-trusted” drugs and “treatment plan designed by a doctor.” Great care went into the phrasing of the minute-long spot, designed to entice viewers to purchase its knockoff of the Type-2 diabetes treatment GLP-1. Noticeably missing was any warning of side effects, risk factors, the lack of safety testing, and regulatory accountability that patients are accustomed to. Even more noticeable was the absence of the phrase, “FDA-approved.” That is why Sen. Dick Durbin (D-IL) and Sen. Roger Marshall (R-KS) called on the agency to investigate companies that “glaringly omit critical safety and side effect information.”
“We believe FDA may already have the authority to take enforcement action against marketing that may mislead patients about this company’s products,” the bipartisan pair said in a letter to the agency.
Such a review is overdue—and it should shed light on more than just marketing but the operations of the murky world of knockoff drugs that Hims/Hers increasingly dominates. The chief savings that sustain such discounts are the elimination of regulatory safeguards, research and development, rigorous testing, and scientific ingenuity that sustain groundbreaking medical research, and of course the fact that the doctors in this case are associated with the compound operations themselves.
Super Bowl viewers may not realize that the drugs that compound chemists make do not undergo FDA scrutiny, leading to products that could contain harmful impurities, incorrect dosages, or even entirely different active ingredients. In 2012, the New England Compound Center accidentally poisoned hundreds and killed more than 60 patients with tainted medicine. The tragedy was made even more complicated by the fact that the FDA could not issue a recall, nor easily trace the root of the deadly outbreak. Patients may believe they are receiving a life-enhancing medication, but instead some experience severe health crises with little recourse.
Patients who turn to knockoff medicines take for granted that any treatment plan they are prescribed has been vetted by the FDA. But Hims and Hers doctors operate under the umbrella of the organization itself, rather than the patient. Their job is to sell direct from the company store. That assumes the patient even gets the privilege of meeting with a doctor. Last spring, an investigative reporter was able to obtain a GLP-1 knockoff from the compounding giant without ever consulting a physician. She merely filled out a survey and qualified for the knockoff without submitting blood tests or any other examination. The closest she came to a thorough review was “what appeared to be an automated message in a chat-box about how to inject.”
The proliferation of cheap imitations and the multi-million-dollar unregulated counterfeit operations that emerged in the wake of GLP-1’s success threatens the very innovation they mimic. Developing a new drug is a costly and time-consuming endeavor, with pharmaceutical companies pouring billions in research, trials, and development over many years. US intellectual property (IP) rights are the lifeblood of this process, ensuring that companies that create such revolutionary treatments should profit from them, and reinvest that money to spur the next breakthrough. When copycat drugs flood the market, they directly undermine not only the patients of today but the future. The hard work and intellectual effort of visionaries and innovators can be easily exploited for profit without repercussions for pharmaceutical pirates.
Trust in medicine is at an all-time low. Between April 2020 and January 2024, patient trust in medical institutions plummeted by 45 percent, according to a survey of nearly half a million Americans. A mere 40 percent of patients expressed trust in their doctors and hospital systems. In the wake of COVID-19, it is essential that the medical community and public health agencies should make it their top goal to restore trust in the practice of medicine. Super Bowl viewers instead witnessed a company trying to capitalize on this distrust and sow further doubt about the very innovators who made their drugs possible, all the while engaging in shady, unregulated, unaccountable operations. When patients are exposed to subpar or potentially dangerous alternatives to established drugs, it erodes confidence in the entire field of medicine and pharmaceuticals.
If policymakers and patients are looking to build a healthier America and restore trust in medicine, they will fight for intellectual property safeguards and level safety playing fields that reward innovative researchers and doctors interested in improving the lives of future generations—not just in plagiarizing proven successes for pennies on the dollar. The FDA can take a crucial first step as its answers the bipartisan call for review.
Charles Sauer is president of the Market Institute and author of “Profit Motive: What Drives the Things We Do.”
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