It’s been about a month since the FDA published the first-ever official guidance on the use of social media for prescription products - and there are still a ton of questions left unanswered. Fingers are crossed in anticipation that the sequel(s) (set for release by the end of 2014) will address the existing concerns.
For a breakdown of the unfolding social media guidance and regulations, I interviewed Razorfish Healthware specialists Dylan Trent - Manager of Regulatory Affairs an expert in quality control as well as medical, legal and regulatory consulting and submissions, and Argelio "Arch" Dumenigo - Strategy Director and social media lead with nearly a decade in healthcare and social media consulting and strategy.
Arch Dumenigo, Strategy Director
Dylan Trent, Manager Regulatory Affairs
Q: What’s the current landscape like for pharmaceutical (pharma) and social media?
Arch: The landscape is fragmented. We’ve dealt with clients on various levels of social media maturity. But that’s the case in most industries, we just have to deal with the regulatory issues that come with providing health information. What we’ve seen is that some companies have waited on the sidelines for guidance, but a lot of them dove right in. It comes down to when the reward outweighs the risk. These are common in areas such as diabetes, heart conditions, and anywhere you have a younger or very social audience - such as moms or breast cancer patients – which are some of the most active groups in social media engagement.
Dylan: To go along with that, I think a lot of our clients have dabbled in social media. But the industry in general has not necessarily taken the lead or taken full advantage of the possibilities of social media. Of course, this has to do with the lack of clarity regarding the FDA regulations.
What you’ve historically seen is that a lot of companies or brands start some sort of social media engagement but fail to stay active. This is due to the lack of distinctive regulations and due to the companies treating social media as a one-time or static engagement. There is a mass graveyard of inactive social media.
Q: Can you give us a rundown of how these guidelines came about?
Dylan: Sure. In 2009, the FDA held hearings for various pharma stakeholders including regulators, consumers, and healthcare professionals, which highlighted that there was a lack of clarity on how such a regulated industry like pharma could participate in social media and digital channels without any guidance from the FDA.
Spurred by these hearings and industry outcry, Congress later released Section 1121 of the Food and Drug Administration Safety and Innovation Act (FDASIA) which mandated that the FDA publish their guidelines on social and digital within 2 years of signing the act on July 9, 2014. With the deadline approaching, the FDA released the first in a series of industry guidance’s that aims to clarify its current thinking regarding promotions on the Internet and thru social media.
Q: What do the first set of guidelines cover:
Dylan: The first set of these guidelines have outlined ways for our pharma clients to identify and submit types of interactive content, and real-time, ongoing conversations (the nature of social media).
As part of identifying the submission types, pharma companies are required to submit "interactive promotional media" if the material is "owned, controlled, created, influenced, or operated by, or on behalf of" the pharma company. They must also submit promotional materials if it is provided to a third-party site, and they have any control or influence over placement of promotional materials on that third-party site. Likewise, pharma companies must submit "product-related" user generated content (UGC) if it is written by their employees, agents, or third parties "acting on behalf of the company".
The guidelines also gave pharma companies a way to submit those materials to the FDA in a few different formats - for both owned properties and third party sites. For static owned properties with "interactive promotional media", firms should submit at the time of first use, and provide annotations describing the interactive parts of the media. Updates to the interactive content should be captured via annotations to the updated page or section and resubmitted on a monthly basis, cross-referencing to the original submission.
Compliance with third party sites is different. Pharma companies participating in third party sites using interactive communications (i.e., Twitter or Facebook) are required to submit the home page along with the interactive pages within the site all at the time of initial display, including the firm’s first communications (i.e., profile page and first post). If the pharma company remains active in the discussion, they are required to provide a monthly update of the sites ongoing social media participation.
If the sites are publicly accessible, then the company only needs to submit a monthly listing of the URLs to the FDA indicating where these discussions are taking place. If the site is password protected, then the company should submit the URL list as well as screenshots of the interactive content, indicating which content is their property.
So, that’s the first part. Then, they published an agenda for the year that highlights all the other types of guidelines that they will be publishing.
Arch: Still, we expect the level of engagement to increase even for the more hesitant of segments. This new guidance doesn’t answer all of the questions, but it does give people an understanding of what they need to do. It should move pharma companies to increase resources in social media, which many need to do to ultimately be more focused on the needs of their patients.
Q: What other types of guidelines are needed:
Dylan: Quite a bit; perhaps updates on how we deal with adverse events, response times, character space limitations, 3rd party misinformation, how to use links, and specific channels (how to deal with Twitter, Facebook, or YouTube specifically).
But, the good news is that we’re getting a lot more guidance and direction in terms of what we need to provide the FDA so that we can be compliant and participate in a valuable way in that space.
Q: What advice do you have for pharma pursuing social media moving forward?
Arch: For those who are still hesitant; now is the time to move foreword and invest resources in social media. Social media is not a campaign, nor does it have an end-point. You continually have to nurture those environments. Or, at the very least, make sure that you have an exit-plan, like when you hand over the community to a patient group or disease awareness association. The idea that you set-it-and-forget-it doesn’t fly with social media, you have to: monitor, moderate, nurture, and plan on being there for the long haul, or have an exit plan (which we’ve seen as more of a trend in the last year or so).
"The idea that you set-it-and-forget-it doesn’t fly with social media, you have to: monitor, moderate, nurture, and plan on being there for the long haul"
Q: What about global social media regulations?
Dylan: Regulations vary from region to region (and country to country). Globally there are a lot of different agencies that regulate the materials and the industry. So our job is to do the research, to understand those regions, make recommendations, potentially apply the tempered versions of the stringent learning’s from the US, and, of course, make sure that we’re complying with the guidelines of the global markets.
Arch: I agree. I haven’t necessarily seen any global reaction to the FDA guidelines. How we’ve always dealt with it is that each country has had their own type of regulations. The one thing you might see is countries that say ‘hey these guys did it - why don’t we?’
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