On Label: How do you embrace fair balance creatively in health care advertising?

Keeping It Creative With Fair Balance (Download Your Free Guide)


Wait, does this seem like too much warning info?

When we last encountered our brand manager, Janine, she was navigating the medical legal review process while trying to understand FDA guidances. It wasn’t easy, but she thinks she managed it with her dignity intact. Now she has a new challenge: How can she present risk information without turning her collateral into one big warning message?

Cue: Third Person Limited Narration

Janine likes the new competitive flashcard that her agency sent her. She especially likes the eyebrow above the headline that she asked them to add. It provides better context without sacrificing the punchiness. A perfect solution — if she does say so herself.  

There’s just one problem — okay, two: She still wants the CTA to be more prominent. It is hidden in the bottom corner. And she wants to include a product shot in addition to the lifestyle image there already. In Janine’s mind, urologists should think of that bottle every time they write a script for interstitial cystitis.  

But that means there is no room for ISI on the front page anymore. The changes she wants would push all the risk information to the back.

Maybe moving the info wouldn’t be such a bad thing. Half of the piece seems to be warning info, and, honestly, there still might not be enough room. Maybe she could have the font size reduced on the ISI. Is that okay? It seems like it should be. The risk info takes up the whole back page. That’s about as balanced as you can get, right?

Janine is looking for a workaround to what FDA calls “fair balance.” It’s actually a really big deal and sometimes lands pharmaceutical and device manufacturers in hot water. Let’s unpack what this concept entails and how marketers can be sure to observe it.

What does FDA mean by “fair balance”?

According to FDA, “fair balance” means “the content and presentation of a drug’s most important risks must be reasonably similar to the content and presentation of its benefits.” This principle applies to any presentation of the product that includes benefit information, such as a magazine advertisement or a tweet describing the beneficial properties of the product. The rule applies to prescription drugs.

Strictly speaking, fair balance doesn’t apply to restricted devices. At least, FDA never overtly says that it does, a position that leaves device manufacturers to bemoan the lack of clarity around device promotion (i.e., “Does this rule apply to us or not?”). FDA explains that although regulations like fair balance were developed “in the context of prescription drug advertising, the guidance they provide on what FDA considers false or misleading in promotion has broader applicability.” Thus, while fair balance is most properly a drug promotion regulation, the overarching effect of a full, balanced product representation should be applied to device promotion, too.

At its root, fair balance is straightforward. It is just what it sounds like: if you include a benefit, you must include a risk. You balance the two. What’s hard is making yourself actually devote space and attention to risks.

A complete picture of a therapy provides semantic balance in addition to statistical balance. Yes, FDA considers adverse events (AEs), contraindications and treatment failures to be parts of the complete picture of a therapy — rightly so — but FDA also considers page layout, colors, images and a variety of other design and copy elements to be parts of this complete picture. It’s not enough to present a drab list of AEs in a boring, small font that is barely noticeable next to a glitzy, brightly colored list of benefits. Likewise, it’s not compliant to say a drug frequently causes fainting and then show a hypothetical patient free-climbing in the Andes. Such a hobby would never be advisable for a patient on such a medication, and we wouldn’t want to suggest that the activity will now be possible for the patient. This would be a minimization of a known risk and wouldn’t be fairly balanced. Balance is needed in content and in presentation.

Is there a secret to getting fair balance right?

The secret is creativity. Let’s put the same amount of creativity into the presentation of risks that we put into the presentation of benefits. That simple principle will ensure that we are doing our best.

Ignoring fair balance means that we are suggesting our product to people whom it may harm, and if we truly believe in our product, then we believe that it will still shine even if we’re completely honest about its efficacy. So, let’s be creative in presenting the full picture to our audiences.

What should our approach be on a more granular level? Thankfully, FDA details some of the specifics. Here are four principles that we at 2e always keep in mind when designing an advertisement.

Jeez, can’t I just leave this stuff to my legal team?

It’s easy to say, “Let’s run with it and see what legal lets us get away with.” I would posit that it’s better to find out this risk threshold in a pre-review or to avoid it completely. It’s incredibly wasteful to have to go back to the drawing board once you feel like the collateral is buttoned up. Knowing what you can and can’t do beforehand can help you strategize. Instead of being crestfallen after a devastating review, you can anticipate problems and circumvent them without wasting precious dollars. There’s no reason to have to attend the professional congress with a subpar booth, all because you had to go back to the drawing board at the last minute. Or develop a shoddy banner because your really cool one couldn’t be used on a certain site.

Want to know more?

Check out FDA’s guidance on the subject and the CFR, too. You’ll find them surprisingly readable. And if you don’t have time to read up, then hit us up. We’d love to get to know you and what you’re working on.

Next month we’ll catch up with Janine as she tries to get some convenience claims approved. Until then, may 2018 greet you with success … compliant success.

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