The Safety Dance
Whenever I begin designing a website, I imagine what it would feel like if, just once, I had the freedom to use the entire screen. Oh, how wonderful it would be if I didn’t have to worry about incorporating a gigantic block of text, firmly stationed at the bottom of all my pages, preventing my beautiful secondary CTAs from being seen in all their glory. For once, my secondary CTAs would no longer have to peer over this fence labeled “Important Safety Information,” praying that users would scroll just a tiny bit so that they could surface into view.
You see, all of my clients are US pharmaceutical companies and the websites I design are almost always websites that market prescription drugs. If there’s one certainty with these types of sites, it’s that ¼–⅓ of the page will have to be reserved for a substantial block of copy known as “fair balance.”
If you have ever searched for medications online and ended up at a brand’s website, you might have noticed a stark contrast between some of the components on the homepage. The majority of the page would be filled with inspiring, positive images of happy (but not too happy) people loving life with bold headlines highlighting how beneficial and effective the drug is. But not too far away, looms that large rectangular box at the bottom or along the side outlining all of the risks and side effects associated with the drug.
Or, perhaps you’ve seen a commercial for a drug on TV. These commercials are usually rife for parody because the way that they’re structured make them seem contradictory — as though the risks outweigh the benefits. The first minute usually features an actor talking about how great Drug X has been for them, before an omniscient narrator’s voice takes over for the following two minutes and runs through a laundry list of all the potential dangers of Drug X. Both the website and TV commercial are examples of the “fair balance” that is required by the FDA for all promotional materials used to market a drug.
I would think that the very definition of the word “fair balance” would imply that a 50/50 split between benefit and risk is necessary but that is not the case. The FDA itself says “this does not mean that equal space must be given to risks and benefits”. They go on to say that the “presentation of a drug’s most important risks must be reasonably similar to the content and presentation of its benefits” but who would be in charge of determining what’s “reasonably similar”? Something that’s similar to one may be quite different to another. I mean, I get annoyed at work when someone tells me we’re “Twinsies” just because we’re both wearing sweaters.
In addition to the subjective nature of many of these rules and regulations, another challenge is that there are no real definitive resources out there that provide concrete rules in the digital space. The FDA has a small library of guidance documents for drug advertising available but has been slow in keeping up with the emerging technologies and determining how pharmaceutical promotion fits in. There are plenty of examples describing what to do in print and broadcast but when it comes to anything remotely digital, there is an absence of guidance from the FDA — you pretty much have to take a hybrid of the print and broadcast rules and jam it together to make them fit in the digital world. Maybe someone forgot to update the cover pages but one particular guidance document I have been referring to has been in Draft mode since 2009 and it’s supposed to represent “current thinking on this topic.” In 2009 my “current thinking” involved playing with the idea of opening a shrimp restaurant called Big Shrimpin’ (my jingles would be a play on Jay-Z’s Big Pimpin’). A lot has changed since 2009.
With somewhat subjective regulations and a lack of guidance directly addressing the digital execution of fair balance, there is a little bit of room to be creative in this constrained space. This is the unique design challenge that we face in healthcare — how to marry regulatory requirements with the best user experience.
There are so many factors that will contribute to determining what your fair balance solution should be. Every pharmaceutical company has their own standards and rules, as well as their own regulatory team to dissect and approve each promotional piece. On top of that, within the regulatory team, there are individual members with their own interpretations of the FDA’s guidance.
This is why, with every drug website project, there are always a few items that I need to know before I begin:
- Minimum. What is the minimum amount of the ISI that must be displayed (e.g., number of lines? percentage of page?)
- Black Box. Is the drug a black box drug that might require special treatment of the ISI?
- Important Safety Information. Does the summary of the ISI have to be displayed at all times or just the first time a user is viewing a page?
- Indications. How many indications does the drug have? Does the full indication have to be displayed? Does it have to be displayed at all times?
- Responsive. Do the same rules apply for smaller screen sizes? If not, what is acceptable?
Based on the answers to these questions and with the expertise of our own medical communications team, we bring forth a solution to our client’s regulatory team. This is the point when the safety dance begins. I have always thought of this process to be not unlike the final scene in Flashdance (minus the fantastic soundtrack). Our fair balance solution would be like Jennifer Beals, ready to shine and trying to push the boundaries of what’s traditionally accepted. The regulatory team on the other hand would be lined up like the panel of judges — adjusting their glasses and waiting to study our every move.
There is usually some negotiation that takes place, a tango back and forth. I will usually try to push for every millimetre I can get to give design the biggest stage while they will most surely defend for safety and compliance. At the end, we both have one common goal — avoid receiving a letter from the FDA for over emphasizing the benefits of the drug. Usually, the solution falls into one of the examples below:
NOTE: The terms I have given to the following examples of fair balance treatments are strictly here to help identify the different options available and are not official labels that are widely used in the healthcare industry. The examples are applicable to desktop treatments.
The Bottom Drawer
This is the classic and timeless standard that has sat at the bottom of most prescription drug websites for years. Defined by its efficiency in optimizing its surroundings and functionality, this staple has stood the test of time (whoever first designed this treatment really deserves some recognition).
Some of its features include:
- Displays the most serious risks and side effects of the drug
- Quick access to full Important Safety Information
- Fully responsive and behaves the exact same way on any device
- Fades when user scrolls to location of full Important Safety Information on the bottom of page. (I particularly love how it’s almost as if the drawer tries to blend into the page and pretend it was never even there)
There are two versions of the drawer:
Retractable
This version retracts into a bar once the user starts scrolling, completely opening the screen area to provide maximum screen space. This is my personal favorite for ISI treatments.
Persistent
The persistent version of the drawer remains on the page at all times unless the user has scrolled to the location of the page where the full ISI resides. Most pharma websites use this version.
The Teleprompter
This treatment for fair balance is quite rare. Here, the safety is confined within a much smaller container but because it automatically scrolls through, the requirement to “show” the most important safety is satisfied.
The Bunk Bed
EntyvioHCP, HUMIRAPerspectives
*Again, I cannot stress enough that these are not officially accepted terms in the pharma space. Please do not go into a client meeting and recommend implementing the “Bunk Bed” solution because you will be greeted with blank stares and nobody will know what you’re talking about.
The Bunk Bed’s defining features are two separate compartments: one for indication(s) and one for the safety snippet. If there is a regulatory requirement to display the full indication(s), this is usually the solution. On mobile, the requirement is usually not as stringent and the rule is softened based on the smaller size of the screen. Having to satisfy this requirement is quite challenging because there is no way of escaping that your user will be greeted with a wall of copy upon arrival.
The Sidewinder
The Sidewinder shifts the location of the traditional Bottom Drawer to the side on desktop. There have been some nice executions of this treatment but I have to say, I’m still a Bottom Drawer kind of guy. This treatment does use the gutter space that is often wasted in designs but I don’t think the Sidewinder is as efficient in optimizing space and reusing elements as the Bottom Drawer execution. If you start closing the walls on the Sidewinder a bit (e.g., put it in an iPad portrait mode), you will see the Sidewinder’s true self. It will transform into a Bottom Drawer before your very eyes. I’m not a fan of people that try to pretend to be something that they’re not and the same goes for fair balance design treatments… if you’re a Bottom Drawer, be proud to be a Bottom Drawer! The reality is, on a mobile device, every treatment eventually becomes some variation of the Bottom Drawer.
Through long discussions, sprinkles of customization and adjustments here and there, a solution is eventually accepted by the pharma company’s regulatory team. This is when the safety dance concludes for me but for our Creative and Medical Communications teams, it’s just the beginning. They’ll have to worry about a whole new set of challenges, like photoshopping someone’s smile because the FDA thinks she appears too happy. This is usually the point of the night where I say “Good luck with that” and take a cab home.
