Just what is a "screen" of data? Analysis of FDA's guidance on brand vs. generic drug names
On January 24, the FDA released a Guidance to Industry about the use of brand (proprietary) and generic (established) names. In this guidance there is an attempt to articulate when and where the generic name needs to be included with the brand. Mostly, the document is a clear restatement of industry best practices but under the “Electronic and Computer-Based” section there is a zinger (wait for it).
If the proprietary name is not part of the running text (e.g., headlines, taglines, logos, footnotes, graphs, or pictures), the established name is required to accompany the proprietary name each time the proprietary name appears.
No problem. Whenever the brand appears outside of the main body of the web page we need to include the generic name. All well-crafted sites adhere to this requirement already. Then the guidance goes on to state:
If the proprietary name is part of the running text, the established name is required to accompany the proprietary name at least once in the running text.
This seems reasonable, when mentioning the brand name the web page needs to use the generic name in the format “Brand (generic)” on first occurrence and can then mention just the brand name alone on the rest of the “column of text”. That is, except:
If the running text spans more than one screen, FDA recommends that the established name accompany the proprietary name at least once per screen.
Woah. Now we have a new measurement that has not been previously defined… the “screen”. Personally I haven’t thought about screens of text since I was designing 80×25 character-based screens for IBM’s System 360 mainframe terminals.
Now, the industry talks about the “fold” sometimes, but that is in relation to non-column based pages such as home pages etc. Content-focused pages are typically considered just the “page” with the understanding that readers will consume the parts of the page in which they are interested.
Also, a “screen” of information varies almost infinitely based on the size of the screen, the size of the browser’s display area, the number of toolbars on the browser, the current zoom factor on the browser, the computer’s font size settings, and more. That doesn’t even take into account mobile devices such as smartphones and tablets which have wildly different screen sizes and usage patterns.
Adding to the confusion about what a “screen” of information is, digital brand advertising often uses display ads to get messages out. To date industry best practice has been to put ISI in a space somewhere between one-third to one-half of the area of the ad and to use the brand name throughout with only one mention of the generic name at the top. The ISI section of an ad typically scrolls inside its own space. So, this means that the headlines and graphics, all of which will have the brand and generic names, will be directly in front of the reader when scrolling through the ISI.
In the example to the left (or above, depending on your screen) notice that both the brand name and the generic name are in front of the reader even as the ISI in the white box is scrolled down.
This guidance seems to open more questions than it answers, and not for any obvious benefit. It seems unlikely that online readers were missing the generic names previously, if there is a retention difference it is almost certainly because the brand names are easier to remember than the science-based generic names.
Will this mean that all mentions of brand inside the ISI will now have to include the generic name? If so, will this make the information even harder to read and understand for consumers and patients? Given that the FDA found no issues with distraction in TV ads it is hard to see where this guidance is coming from. The guidance talks about the correct labeling being important for safe and effective use, but it is difficult to see how repeating the generic name with the brand on every mention will improve this.
