And though it starts out with the line “We need to have a chat about Zofran,” it isn’t technically an ad for the drug, it’s an ad for Wisp, a telehealth company, with the content creator identifying herself in the caption as a “#WispPartner” and the payoff coming at the end of her minute-plus monologue: “Beware of the side effects, talk to your doctor, but the easiest way to get Zofran is through Wisp,” she says. “You’re welcome.”
At first glance, the video doesn’t appear to meet the Food and Drug Administration’s minimal requirements for pharmaceutical advertising. From the F.D.A.’s website: “All product claim ads, regardless of the media in which they appear, must include certain key components within the main part of the ad: The name of the drug (brand and generic), at least one F.D.A.-approved use for the drug, the most significant risks of the drug.” For starters, the ad doesn’t mention the generic name of the drug, ondansetron.
The ad does mention one significant risk, serotonin syndrome, for people who take selective serotonin reuptake inhibitors, the antidepressants known as S.S.R.I.s, but it doesn’t mention that the F.D.A. finds that “abnormal heart rhythms may be associated with use of Zofran.” Per the F.D.A., “Product claim ads must present the benefits and risks of a prescription drug in a balanced fashion,” and I’d argue that this one does a lot to tout the benefits while underplaying the risks. (When contacted by The Times, Wisp did not comment.)
But it turns out this particular video might be exempt from the F.D.A.’s pharmaceutical ad rules precisely because it’s for a telehealth company rather than for a drug manufacturer, and telehealth companies may be structured to skirt these regulations. This is something I wrote about last year, when I realized that Ketamine ads were following me around on the internet. Indeed, as The Wall Street Journal’s Khadeeja Safdar and Andrea Fuller reported in 2022:
Many telehealth companies said they aren’t subject to F.D.A. advertising rules because they aren’t drug manufacturers. Most telehealth companies are set up as two legal entities — a corporation and a medical group. They said they use social media advertising to educate consumers about treatments and refer inquiries to nurse practitioners or physicians, who are overseen by state licensing boards.
In an email, an F.D.A. spokesperson said that in general, the F.D.A. regulates the marketing of prescription drugs in advertisements “that are issued by or on behalf of that drug’s manufacturer, packer or distributor.” The spokesperson added, however, that “these laws may apply to telehealth providers and websites, depending on what activities they undertake and how they are structured. Assessment of what authorities apply to a particular situation is necessarily dependent on the specific facts.”
In a February letter citing The Wall Street Journal’s reporting, Senators Mike Braun of Indiana and Dick Durbin of Illinois called on the F.D.A. “to take swift action to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics.”
