Top Three Things You Need to Know About the New Draft Guidance
The new FDA Draft Guidance for Internet/Social Media Platforms with Character Space Limitations focuses specifically on the use of online microblogging platforms such as Twitter, as well as online paid search (sponsored links on Google/Yahoo/Bing). The agency made clear that this guidance does not apply to more “traditional” channels such as websites, webpages on SM platforms, and web banners. Nor does it directly apply to responsive web design.
The overall goal of the guidance is to aid firms in communicating risk and benefit information in product promotion using platforms with character limits. However, with products having complicated labels or serious risks, there is a chance that the platform may not allow meaningful, balanced use. A decision to not use a platform due to lack of balanced content should be considered if balance cannot be achieved.
The very specific and very helpful examples in the guidance cover several major concerns, while also addressing many of the nettlesome issues that #digitalhealth and #ePharma marketers have been grappling with for several years.
1. The message should have a comparable balance of risk and benefit, regardless of character space constraints.
a) Benefit should be accurate, nonmisleading, factual
b) Risk should be part of each communication
c) Symbols (such as &), punctuation marks, and scientific abbreviations can be used to help reduce space constraints
2. The primary link should be provided for more complete information about risk.
a) The primary destination should provide comprehensive risk information about the product
b) The secondary link and destination can be considered along with the primary link
c) Links should indicate topic of destination (for example, www.nofocus.com/risk)
d) The destination page should have the brand and established name together with dosage form/quantitative ingredient information (logo lockup)
3. A decision to not use a platform due to lack of balanced content should be considered if balance cannot be achieved.
a) The complexity of the indication and side effects should be considered
b) Most serious risks should be included as a baseline
With more than 500 million tweets being generated daily and new targeted online advertising options surfacing on a regular basis, it is clear that short-form messaging and advertising is going to remain a major fixture of the media landscape for the foreseeable future. In the midst of this messaging onslaught, the new Draft Guidance from the FDA is a detailed, timely, and, most of all, practical roadmap for marketers who are striving to condense complex pharma marketing language into 140 characters.
This post is provided by Cadient for information purposes only and is not intended and should not be construed as regulatory or legal advice.
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