Super Bowl commercials provide an enormous stage for companies trying to gain the attention of the American public, but we usually don’t see commercials from drugmakers during the big game. And for good reason. The familiar read-out of warnings and side effects that are required by federal law (and help make a drug ad truthful and non-misleading) generally aren’t as fun as mean Joe Greene or Budweiser’s Clydesdales.
This Super Bowl, however, is poised to include an ad from the maker of a “compounded” semaglutide drug, Hims and Hers Health. But this drug ad is different because it does not include any warnings or discussion of the side effects that may come from taking semaglutide. So, why does Hims seem to be able to ignore the statutes and rules that are enforced by the FDA and followed by every other drugmaker?
There’s no good answer to that question. When Hims announced the ad buy, it apparently told The Wall Street Journal that it is “exempt from long read-outs of risk and side effects” because, supposedly, Hims merely “connects customers to healthcare manufacturers but doesn’t sponsor or manufacture drugs.” That can’t be right. For one thing, Hims’ securities filings show Hims controls every aspect of its drug, including its manufacture and distribution. But setting that aside, I have successfully sued FDA on First Amendment grounds; I have also been its chief counsel and the general counsel of GlaxoSmithKline, a large pharmaceutical company. I can state with confidence that no such exemption exists.
Why FDA would tolerate this commercial or Hims’ open challenge to its authority is, frankly, mystifying. FDA has a long history of aggressively enforcing the laws and regulations that apply to drug ads. Abandoning that history for this ad will put patients at risk. Semaglutide is an injection and must be completely sterile to be safe—any mistake can lead to dangerous contamination. Which is why FDA generally inspects legitimate drug manufacturers before they are allowed to sell sterile drugs to the American public.
“Compounders” like Hims are not inspected before they go to market, and when FDA does get around to inspecting compounders, it almost always finds serious problems. A quick look at FDA’s roster of inspections, recalls, and other actions details page after page of concerning findings. In December, FDA cited one compounder that had to recall knock-off semaglutide for “lack of sterility assurance” caused by 20 violations, including insects in the clean room. In November 2024, FDA warned patients and doctors not to use another knock-off semaglutide because its maker “took no steps to sterilize them.” These and other incidents are eerily reminiscent of the infamous 2012 disaster where the New England Compounding Center (NECC) distributed contaminated injections that killed more than 100 Americans and made hundreds more severely ill.
Like any prescription drug, semaglutide carries risk. For instance, the FDA-approved labeling for semaglutide includes a boxed warning (the most serious type) regarding a form of cancer and several other precautions. Semaglutide also is contraindicated in some patients. But you won’t hear any of that in Hims’ commercial.
FDA’s special tolerance for Hims and other compounders also threatens to undermine the incentive to innovate. Hims’ semaglutide has not been studied in any clinical trial or reviewed by FDA. Instead, Hims is unfairly copying a drug that was invented by Novo Nordisk. The narrow statutes Congress passed in 2013 following the NECC disaster were intended to restrict compounding, not throw open the gates to large-scale distribution of unapproved knock-offs. But that’s exactly what has occurred on FDA’s watch and, much like the Biden administration’s sham Medicare drug price “negotiations,” FDA’s hands-off approach makes it less likely that the next pharmaceutical breakthrough will happen in America.
But FDA’s failure to enforce the laws written by Congress also undermines the incentive to seek FDA’s approval for generic drugs. Generic drugs are FDA–approved copies of innovative drugs, and they generally carry the same assurances of safety and efficacy as their branded counterparts. But generic drugs are subject to things like regulatory exclusivities and patents, they require at least limited studies, and they require FDA inspections for quality.
I don’t see why a rational drugmaker would continue to incur those expenses. In the new world that FDA has created, it seems much easier to skip all that, call yourself a compounder, and go straight to market with an unapproved knock-off. Plus, you apparently get to say whatever you want on TV, including, if you have the money, during the Super Bowl.
