In August 2015, the US Food and Drug Administration sent a warning letter to Duchesnay, a Canadian drugmaker, after Kim Kardashian told her Instagram followers that its morning-sickness pill Diclegis had made her feel “a lot better”. The post was cheerful, paid for and, in the agency’s view, misleading, because it presented efficacy claims with no risk information. The post had gathered almost half a million likes before it came down, and corrective messages had to go out on the same channels, to the same audience.
The case is remembered as a lesson in fair balance. The harder lesson sits lower down the screen.
Creator campaigns invite conversation, and conversation about medicines produces safety information. When a follower replies underneath a sponsored post to say a product made her symptoms worse, that comment may be a reportable adverse event, and adverse-event reporting is a legal obligation with deadlines attached. A campaign brief that plans for reach and engagement while ignoring pharmacovigilance has planned for half the job.
The volumes involved are not trivial. A single creator post can outperform months of activity on a brand’s owned channels, and every reply beneath it is a potential doorway for safety information the company will later be deemed to have seen.
Owned, Paid For or Controlled
The rules here are firmer than marketers sometimes assume. Under the EU’s good pharmacovigilance practices, companies must regularly screen digital media under their management or responsibility for potential reports of suspected adverse reactions, and a channel counts as company-sponsored if it is owned, paid for and/or controlled by the marketing authorisation holder. A paid creator partnership sits comfortably inside that definition. Nor is screening frequency left to taste. It must allow valid cases to reach regulators within the statutory clocks, 15 days for serious reactions and 90 days for non-serious EU cases, counted from the date the information appeared online.
What turns a comment into a valid case? Four elements: an identifiable reporter, an identifiable patient, a suspect medicine and a suspected reaction. A vague grumble from an anonymous account may not qualify. A named follower describing her own symptoms after taking the product very likely does, and the company is then expected to attempt follow-up rather than look away.
The UK has just restated the point. The PMCPA’s revised social media guidance, published in early 2026, treats influencer arrangements like any other consultancy under the ABPI Code, with due diligence, written agreements and active monitoring of the creator’s account, including user comments, for pharmacovigilance purposes, at least for the life of the contract. Companies answer for the acts and omissions of third parties working on their behalf.
“The agency posted it” has never been a defence.
What Separates Campaigns That Survive Scrutiny
So what does competent handling look like in practice?
It starts before anything is published. The creator’s contract defines an adverse event in plain language and requires anything resembling one, whether it arrives in comments or direct messages, to be forwarded to a named company contact within a tight, agreed window. The creator is trained on this once, briefly and in ordinary words, because a wellness creator with two million followers has generally never heard of an individual case safety report and should not need to.
The monitoring plan is then built around the reporting clocks rather than the content calendar. Screening is most intensive while a campaign is live and engagement is high, and every route leads to one place: a single escalation path into the safety team, so a community manager is never left deciding alone whether something is reportable. Comments containing possible safety information are not deleted. MHRA advice is to signpost users to official reporting channels instead. And every judgement is documented, including the judgement that a comment did not amount to a valid case.
None of this is exotic. It is the machinery companies already operate on their own channels, extended by contract to somebody else’s. Resourcing is the honest constraint, particularly for smaller companies running their first creator work.
There are genuine grey areas, obviously. Where sponsorship ends — whether at the creator’s spontaneous follow-up post, the fan repost or the private message — is not cleanly settled, and the FDA’s core social media guidance dates from 2014, before TikTok existed. Regulators tend to answer such questions case by case, which is another way of saying nobody should bank on the generous interpretation.
Eleven years on, the Duchesnay letter remains the slide every compliance trainer reaches for. The post came down and the corrective messages went out. Yet the question that should follow any creator campaign in 2026 is no longer whether the caption is balanced. It is who is reading the comments, how often, and what happens when one of them describes a side effect.
