Recent FDA Guidance on advertising via character-limited platforms offers risk-benefit compliance recommendations for pharmaceutical PR teams.
The FDA is tasked with regulating pretty much all aspects of drugs and medical devices in the US, including “promotional labeling” – or, advertising, as the rest of the world refers to it. In short, if you’re putting a drug ad out there, you can be sure there’s FDA oversight.
So it stands to reason that online marketing is subject to scrutiny. The Agency has already spoken on post-marketing reporting requirements via Guidance issued in January 2014.
But reporting on your online pharmaceutical communications is just one issue. There are a myriad of other FDA regulations that apply no matter where you’re advertising, and they raise additional questions – requiring more FDA Guidance. In June 2014, the Agency stated its position on how healthcare PR executives can adhere to its rules when using platforms with limited characters (aka, Twitter, Google Ads, etc). Fortunately, the Guidance includes great details, examples and tips; the downside is the legal mumbo-jumbo.
While only your legal team can tell you how these issues apply to your marketing efforts, you can really use some answers to the questions you’re asking.
So what’s different when you promote products via channels with limited characters?
Actually, nothing: Firms still have the long-standing obligation to make sure promotions are truthful and not misleading by presenting balanced risk-benefit information – no matter what the method or media channel. But this guidance specifically addresses platforms associated with space limitations, such as Twitter and the sponsored ads you might place on Google or Yahoo! There are definitely challenges in fitting all the required messaging in 140 characters or less.
The FDA’s view is that it’s possible to use these platforms to promote products by following certain recommendations. And you can learn how simply by analyzing all 544 lines of text spread over 15 pages!
Any guidance on getting to the bottom of the Guidance?
Yes, since you likely can’t invest a work week into deciphering it. Here’s the breakdown what the FDA recommends on presenting risk-benefit details.
Benefits: The FDA says you’re good to go in stating benefits if material facts about intended uses are accurate and non-misleading.
Risks: These details must be comparable in scope to the benefits, so you should avoid including any qualifying language, e.g., “There are risks, but the benefits are so much greater.” In addition, the Agency suggests firms look at other factors to stick to the “truthful and not misleading” standard:
• Risk information should, at a minimum, include the most serious risks associated with the product – anything that’s fatal or life-threatening, boxed warnings, and all contraindications.
• A mechanism, such as a hyperlink, PDF or even a tinyurl, should be provided within the communication to allow direct access to a more complete discussion dedicated exclusively to risk information.
• The prominence of risk information should be in line with benefit details. If you use techniques (bold, italics) to emphasize benefits, do the same for risks.
What if I can’t fit balanced information on risks and benefits within character limitations?
The FDA keeps it short and simple: If you can’t – don’t. The bottom line is that truthful, non-misleading, balanced product promotion is in the best interests of the public health. Platforms with character limitations may not be the ideal marketing channel if you can’t meaningfully present both risks and benefits.
These and other questions should always be directed to your legal department, but hopefully this clarifies how you should handle healthcare communications on space-limited platforms. We’ll continue to cover your general questions as the job of a pharmaceutical PR executive evolves due to FDA compliance issues.
But for now we wait, as additional Guidances will grace us in 2016 …
By Marc DeLeuw