In marketing and communications, social media is no longer considered new. It’s the new normal. But for the pharma industry, this is not the case. Combine a lack of social media guidance from the Food & Drug Administration (FDA) with strict regulatory oversight and high stakes – what do you get? An industry paralyzed by social media risk.
But, the status quo is changing. In January 2014, the FDA quietly released draft guidance for social media use by pharma companies. It’s important to remember the use of the word draft–these are not set in stone. However, this guidance is a very important step toward official FDA regulation of pharma’s relationship with social media.
While you may cringe at the thought of “regulation” when it comes to social media use, these guidelines actually have the opposite effect on the pharma industry: the industry now has, at least, a yellow light to engage in social media. Up until now, companies did not know what they couldn’t do. So, instead, most took the safest, least interactive (i.e., boring) approach.
To learn more about what these draft guidelines really mean, I participated in MM&M’s recent webinar: “Green light, or go slow: What FDA’s new draft guidance means for social media in pharma.”
The webinar pointed out a number of questions that the guidelines have answered. So, in no particular order, below are a few major pharma concerns that the draft guidelines will help alleviate:
- Will the FDA hold a pharma company accountable for third party commentary?
During the webinar, the term user-generated content (UGC) came up again and again. To start, UGC is content produced by social media users–not the pharma company facilitating the social media profile. For example, if an individual user posts to a pharma company’s Facebook page raving about an off-label product use, can the FDA then hold the pharma company accountable? The answer is no.
Not only is this excellent news for pharma companies, but it also means that patients will have more freedom to engage and interact on official online platforms. That said, patient expectations for customer support and responses from pharma companies will be elevated, so get your internal infrastructure ready.
- Are companies responsible for reporting adverse events identified through UGC on social media?
In short, yes. When patients are allowed to actively interact via social media, issues with a product may come to light. Pharma companies will be held responsible for reporting any adverse events that come to light via social media. Just because an adverse event is reported via social media, does not negate regulations surrounding adverse event reporting.
- At what point is a company endorsing a statement?
This is simple – if a company “likes” a post, “favorites” a tweet, “repins” a pin, etc., that is considered an endorsement. If any endorsement occurs, the pharma company is then considered accountable for the content of that post. In the tamest scenario, this simply means the company must report the content to the FDA. However, depending on the content of the post, this could also mean a company is held accountable for endorsing off-label uses of a product, adverse events, etc.
- Social media demands real-time engagement, but how can a pharma company engage in a timely manner if they must report interactions to the FDA?
This change is huge for pharma companies and patients, alike. According to the FDA guidance, pharma companies can engage in real-time by responding to comments as they are posted. The caveat is that pharma companies must file the pre-launch of a social media platform with the FDA, and then subsequently report all interactions to the FDA on a monthly-basis (vs. in real-time). Since social media is public, the FDA can theoretically monitor conversations themselves, so there is less need for real-time reporting. It’s worth noting that this does not apply if the group is closed.
Hopefully this will help you provide your pharma clients with advice and direction regarding their social media marketing strategy. As the path forward for social media in the pharma industry becomes increasingly clear, it’s necessary to start thinking strategically. That said, don’t forget that these guidelines are still in draft form. And, if you see room for improvement, the FDA is soliciting feedback, so why not respond?
Photo courtesy of Dennis Brekke on Flickr
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