Seeing that phrase on my screen as I idly scrolled TikTok made me stop and watch the whole video, but probably not for the reasons its creator wanted.
Zofran is a drug that prevents nausea and vomiting. I’ve taken it a bunch of times — most memorably at a hospital via IV, when a doctor told me he wanted to “stop the barf cycle” during a bout with norovirus. It also comes in pill form, and it’s often prescribed for cancer patients to offset the side effects of chemotherapy.
But the idea of feeling some kind of warm fuzzies of identification or validation as a “Zofran girlie” is darkly hilarious to me; it’s a sign of how warped social media advertising, particularly for prescription drugs, has become.
The Zofran girlies video asserts that “literally everyone” on TikTok is talking about Zofran, because “it’s so hard to get” — a claim I’d never heard before.
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.”
The senators note that the F.D.A. has not updated its nonbinding draft guidance on social media advertising since 2014. “Consumers can be inundated with promotions for medications from influencers with no expertise, and whether or not the influencer has ever used the medication.” Such ads, they wrote, “often overstate benefits and minimize harms.”
Maddie Carlos, the deputy communications director for Durbin, told me that in its reply, “The F.D.A. indicated that — generally speaking, unless the telehealth company was speaking on behalf of the drug’s manufacturer (i.e. had a financial arrangement to advertise) — the agency’s existing regulatory authority would not apply.” She said in an email that Durbin is considering legislation to address the gap and give the F.D.A. more power to address this problem.
There may finally be real pressure for tougher regulation of telehealth companies as government officials wake up to the fact that many of these companies have been allowed to operate with too little oversight since 2020. That’s when the regulations around online prescribing were relaxed because of the Covid-19 pandemic. (The relaxed rules will remain in place at least until the end of this year.)
In a possible example of stepped-up scrutiny, the chief executive of the telehealth company Done was, as my newsroom colleague Dani Blum reported last week, “arrested and accused of participating in a scheme to distribute Adderall and other stimulants for A.D.H.D. to patients who did not need the medications, and to bill insurers for these drugs.”
While not every misleading ad is tantamount to alleged health care fraud, I’m glad that we may be seeing some additional accountability for telehealth companies, though I’m not entirely confident that the advertising loopholes that they can easily exploit will be closed anytime soon.
Even if those loopholes are closed eventually, I don’t think it’s a good use of the F.D.A.’s resources to spend all day monitoring social media for ads that might violate its rules — the sheer volume of videos and images would be impossible to sift through. We need to do more.
The United States is one of only two countries (the other is New Zealand) where direct-to-consumer prescription pharmaceutical advertising is allowed. Back in 2015, the American Medical Association called for a ban on D.T.C. ads for prescription drugs, citing the amount of money spent on advertising as a driver of ballooning drug costs.
While it may be unrealistic to expect such a ban in a country where commercial speech has historically been protected, I think it’s time to start pushing for one. The risks of an unfettered advertising landscape far outweigh the benefits of informing consumers about specific drugs, especially considering one 2023 study which found that “fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high therapeutic value.”
In the meantime, I take a small measure of comfort from the commenters on the Zofran girlies video calling out how bizarre it is. The top comment: “Nobody should be taking Zofran this much without being actually ill.” Others mention the heart rhythm issue, and a handful of commenters identifying themselves as pharmacists say that Zofran has never been hard to get.
It’s better than nothing, I suppose, but we shouldn’t be relying on an army of random and unverified commenters to give us context.
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