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Compliance, AEs and PAAB, oh my!

Compliance, AEs and PAAB, oh my!

A friend and I recently attended a panel discussion and, while mingling with one of the panellists who previously worked in the healthcare industry, we discussed how rarely social media is used by pharma. My friend, who works in mobile advertising, immediately asked if it was just a question of who would do it first/best. The gentleman with whom we were speaking and my response came almost in unison: “It’s more so who’s going to do it first and not get in trouble.” 
 
In today’s world, the integration of social media into a communications plan is almost essential. The pharmaceutical industry; however, is still trying to test the waters before fully taking the plunge. Why? 
 
Well, firstly, there’s the need to be compliant with Health Canada’s regulations. As you may or may not know, the healthcare industry is extremely regulated. It goes something like this:
 
“A social media platform that encourages disease awareness? Sure, why not?!... Just make sure no one ever, ever makes a comment linking to a treatment or brand.” But how can this be done? 
 
There’s the option on Facebook that allows sponsors to review comments before they’re posted, but doesn’t that bring the whole two-way, transparent conversation concept into question? What’s a disease awareness campaign to do? 
 
In addition to regulation, there’s the issue of adverse event/AE (aka undesired side effect) reporting.  What if a patient broadcasts having a reaction to a treatment? AEs are incredibly serious and should not be addressed the way one might address bad customer service or annoying cell phone contracts. Patients who experience AEs should speak to someone immediately, but in a society where problems are solved with “to the Twitter handle, we go!” how can we ensure patients are connecting with the company in question or a healthcare professional? 
 
And then there was PAAB, the Pharmaceutical Advertising Advisory Board whose mission is to “provide a preclearance review that fosters trustworthy healthcare communications within a regulatory framework for the benefit of all stakeholders.” PAAB is committed to ensuring all advertising and communications are equal, accurate, evidence-based and balanced. Its scope includes promotional product communication for prescription, non-prescription, biological and natural health products to professionals in all media...but what about social media? Does everything posted on a social media platform need to be pre-approved? User-generated content (UGC) can be found on the sponsor’s site, but the presence of this content on a sponsored property can go from compliant to non-compliant by the comments that have been made. For example, if users begin a conversation about a product, it becomes promotional and those discussions could be subject to the regulatory requirements of drug advertising. Thus to PAAB it goes. 
 
Does this all sound like more trouble than it’s worth?
 
There will always be yea-sayers and nay-sayers, so before hopping into the social media world as a pharmaceutical company, it’s important to take the time to really ask questions and think it through.
 
Consider:
- Do you have the in-house capabilities to manage a social media community?
- Does your company have a social media engagement protocol in place? If not, are you willing to invest in one?
- Why do you want to join the social world? Who are you trying to reach? What message are you hoping to convey?
 
And if these questions get to be too much, never fear! Healthcare PR pros are here and want to work through these questions with you. We’re equipped and ready to get creative and social inside the regulation box!
 
Allison Goodman is an Account Coordinator with energi PR’s Healthcare Practice in Toronto.