I had a thirty minute phone call with a director at the FDA in April, 2019 about influencer campaigns for drugs with boxed warnings. She was so helpful! Read on for the insight she provided:

By now we know that pharmaceutical companies have pressed forward beyond experimenting with influencer marketing. Their stocks are soaring, people are living longer, and millennials, who trust influencers way more than they trust you-the-brand-or-agency, are now concerned with their own little ones’ health. It’s the perfect recipe for an addictive marketing drug–with no side effects.

However, you’re also surely aware of, and concerned with, the regulations. There have been only a few FDA wrist-slaps but to a pharma’s legal, the whole idea of giving a contractor on YouTube or Instagram control over the messaging screws up their faces as if they’ve just swallowed the worst tasting cough syrup imaginable. And the legal hassles have one profound side effect: long timelines. Plan on 3-4x the time of a usual campaign. But it’s all worth it; the ROIs for influencer marketing are between $6.50 and $12.00 for every dollar spent.

But what about drugs with boxed label warnings? Can you possibly run an influencer campaign with so many strict regulations? The short answer is yes, but you do need to be aware of some critically important factors. And lawyers don’t like short answers anyway.

Winter Is Coming…But Not For A While

In general, regulatory for pharma influencer campaigns is tough: influencer captions are obligated to use FDA-approved language, the post needs pre-approval from a committee at the pharma, contraindications listed, “fair balance” of benefits and risks, adverse events monitoring in comments…the list goes on a bit further. It is all do-able (we are in the middle of a couple campaigns now) though, so don’t be discouraged! So let’s get to boxed warnings. And, like drugs without boxed warnings, there is a way to legally run an influencer campaign that will satisfy the lawyers who, when presented with the strategy, look like they’ve seen Wight Walkers coming over the wall.

The Wight Walkers – Game of Thrones, HBO

Boxed warnings, also called, “black box” warnings, are mandatory for products that have severe or life-threatening side effects. Incidentally, they’re called, “boxed” warnings because the warning must be embedded in a box:

Besides Celebrex, you’ll see boxed warnings on antidepressants, contraceptives, anticoagulants, and more. This is serious stuff, which is why anyone’s first inclination when talking about an influencer campaign to the Gods of Marketing is, “Not today.”

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What About Unbranded Campaigns?

Unbranded campaigns are those in which the brand and its benefits are not revealed. Think of it as awareness information for a condition, a kind of public service announcement. Typically there will be a link to drug’s site or a coupon download a few steps removed from the site. From the FDA’s perspective, the hairy part is just how many clicks away the product is revealed. This first guidance is called, “temporal proximity”, in the parlance of a federal agency and it makes sense because agency rules aside, consumers hate to be tricked. This goes for boxed and non-boxed warning drugs, by the way.

“agency rules aside, consumers hate to be tricked.”

The second no-no is what’s called, “suggestive content”. This is more qualitative than temporal proximity, and addresses those unbranded media which “look” like the drug in typeface, colors, or imagery. Think of an unbranded campaign for erectile dysfunction that featured a gorgeous, smiling couple on a bed with 1800 thread count sheets under a night dome of stars. You get the idea.

Time to consult the FDA guidance, right?

Wrong. The FDA pulled the earlier guidance on unbranded campaigns as they revise their direction in light of new media like social. And no, they legally cannot disclose when the guidance will be coming (I did ask), but you can get a notification when it’s live by providing your email to their list on fda.gov. And yet again, “suggestive content” applies to drugs with and without boxed warnings.


Absolutely, Positively, “No”

There is only one absolute with boxed warning drugs: reminder promotions. You may not use the drug’s name on any “reminder promotion” unless the boxed warning is present, but at that point you’d want all the other content to go with the promotion anyway, so it wouldn’t be a reminder ad. Think of a reminder promotion as a giveaway squishy stress ball at a conference, with the drug’s name printed on it. Companies have tried to get around this for boxed warning drugs by putting the giveaway in a cellophane package, on which the boxed warning is printed. But that’s too much of a grey area for the FDA director I spoke with. Influencer posts could be used as reminder promotion but it doesn’t seem likely.

So drugs with boxed warnings have all the strict requirements for promotions as those without and only one important outlyer (reminder promotions). But, as with a non-boxed warning drug, there must be “fair balance” in both the imagery and text of a promotion: as many risks as benefits must be present. You can bet that the boxed warning will have to be prominent in an influencer post, but we’ll hopefully learn more when the guidance is published by the FDA.


About MATTR: MATTR, leaders in influencer campaigns for highly regulated industries, is the only full-service influencer marketing provider with detailed audience insights from PersonaMesh™. We go beyond demographics into psychographics such as values and interests so that your influencer campaigns align with your campaign targets.

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