We’re all aware that, in the U.S., when a regulated drug is mentioned in the same breath as the disease state or therapeutic area for which it’s prescribed, that statement must be balanced with information about the drug, which may include side effects or warnings. This fair balance statement typically takes the form of an ISI or Important Safety Information.
In print media, such as magazines, this fair balance is usually shown on the back side of a drug advertisement. You know … the fine print you see on the next page of the magazine. On TV, some of the main safety information is spoken in a voice-over, and then the viewer is often directed to more information in a magazine ad or website. On a website, the ISI is presented on the same Web page as the drug name, as long as it’s above the fold (unofficially).
In those media, the presentation of these messages goes through rigorous review and approval from medical, legal, and regulatory teams at the pharmaceutical company and are then submitted to FDA, specifically DDMAC, for review. The million-dollar question is, what to do in social media? How does a pharmaceutical company present Important Safety Information in a medium that is both real-time and condensed?
Nearly all of the major social media platforms present a challenge to mentioning both a drug name and the disease it’s used for while allowing for an ISI. Let’s take a look …
- Challenge: With only 140 characters to relay any information, an ISI would certainly not fit within a Tweet.
- Solution: Don’t mention a drug name and what it’s used for — simple as that. A link to the ISI has proven still unsatisfactory for current guidelines. One company, Novo Nordisk, put the ISI for Levemir and NovoLog as the image background to their @racewithinsulin Twitter profile page. However, the two problems with that are that the ISI is not text at that point, so it can’t be “read” by computers of those who are visually impaired, and Twitter’s updated format now covers the ISI. But I applaud their efforts.
- Challenge: Both the video content and the Web page on which it’s presented must show the ISI, if the video and text on the page contain the drug name and the disease.
- Solution: For the video itself, be sure that the ISI is edited into the end of the video, either scrolling or as a series of still text cards. If the title and/or description of the video also contains the drug name/disease, then the ISI must also be shown on the Page. This cannot be done with a standard channel (the free kind). If you wish to do this, you must pay for a Brand Channel. A Brand Channel will cost you, but it also affords your videos more promotion within YouTube.
- Challenge: In short posts, you can’t include a long ISI in each and every post. Also, there’s no editable space on a Facebook Web page to insert an ISI.
- Solution: You can create a custom tab that has the full ISI in it, and you can make that tab the default landing tab. I’ve also seen where one company posts the full ISI as every 5th post, so it remains above the fold. Even if Facebook were to allow some space for an ISI on a Page, the number of characters needed for an ISI are much greater than the hallowed page space that Facebook may be willing to allocate.
In each of these social media platforms, you would need a lot of space to show the full ISI. If a platform affords you 75, 140, or even 1,000 characters, that may not be enough. Below are the character lengths of the ISIs for the top-selling drugs in the U.S.
ISI Character Count