Commercials for online prescription companies like Hims get credit for their “un-pharma” creative approach. They’ve diverged from the TV work of Viagra and Cialis, pharma brands which were among the first to take on the taboo of sexual conditions.
But online, their advertising is getting some major blowback. Companies like Hims and Kick Health are “testing the boundaries of medical marketing by advertising prescription drugs for unapproved uses,” reported Bloomberg this week.
Hims markets the drug sertraline, the active ingredient in antidepressant Zoloft, in a low-dose formulation to men for treating premature ejaculation. Kick touts blood-pressure drug propranolol to college students with stage fright.
Both of those constitute off-label uses, even though some doctors do prescribe the two drugs for those uses, and both drugs have data showing they may help some patients with the conditions. The companies have pitched the drugs for those uses in various ways through some of the marketing copy on their websites and social media feeds.
In a March 1 Instagram post (below), Hims says, “Ending the bedroom fun a little too soon? Sertraline can help treat premature ejaculation so sex can last longer for both you and your partner. Tap our Story for more info.”
Whether this constitutes an off-label infraction is an open question, say legal experts quoted by the news service. Then, there’s the matter of possibly exaggerating benefits without adequately warning of risk.
Among Zoloft’s approved uses are depression, obsessive-compulsive disorder and other mood disorders. The FDA hasn’t approved it for premature ejaculation, although there’s some clinical data showing that serotonin-reuptake inhibitors can help with that.
It also packs some serious side effects, one of which is actually “ejaculation failure” and decreased libido. In addition Zoloft comes with a warning on its label that it can bring on suicidal thoughts and behaviors in younger patients.
None of those appear in the post. A previous case suggests OPDP expects companies to be very upfront about warnings and risks and not bury them behind a URL. MannKind got hit with a letter last October for a Facebook post about inhalable insulin Afrezza. The agency said the post, which carried a link to full prescribing information including a boxed warning, nevertheless did not contain adequate risk information. The company was asked to issue corrective advertising.
At the heart of the matter is whether firms like Hims are seen as advertising a drug with all its side effects, contraindications and benefits, or merely selling a doctor’s services. The companies assert that it’s the latter, claiming that their businesses are merely platforms and that it’s up to the doctors they work with to exercise their medical judgment.
“We never touch the drugs. We’re not a distributor,” Kick founder and CEO Justin Ip told the news service. “I wish it was 100% crystal-clear. We’ll see how things go, but we think we’re on the right side of the law. If not, we’ll be happy to adjust.”
Nevertheless, FDA has slapped third party entities on the wrist before, for promoting drugs online before their approval.
The FDA declined to comment on Hims’ social feed, but some consumers have already weighed in. In comments to the company’s sertraline post, Hims takes flack for peddling a medication with serious side effects for an unapproved, “recreational” use.
In the case of propranolol, some have accused the firms of disease mongering through their slick, millennial-friendly marketing. Hims sister brand Hers has already acknowledged that it may have crossed a line. The brand pulled a social media post touting propranolol for anxiety.
Where is this headed? We know that implying that a product is intended for a new use for which it lacks formal approval is a big advertising no-no. So is talking about benefits without appropriately discussing risk.
The problem, as MM&M astutely points out in our just-published annotated guide to the DTC regs, is that “The internet as we know it wasn’t around when the original drug-ad regulations were written, [so] the digital advertising rules have largely been codified via FDA guidances.”
So too here. Online entities may not make these products; they just offer a telehealth consult with a physician. But in what is a legal gray area concerning online prescription firms, we may see regulators step in to make the distinctions a little more clear.