Since social media was widely adopted more than five years ago, the pharmaceutical industry has tiptoed around the edges of the platform, concerned that diving in would obligate companies and brands to keep tabs on and manage all consumer-generated content. If the content is incorrect, patient outcomes and adherence could suffer; but in the absence of FDA guidance, and with limited resources, what can our industry do? Until recently, there has been little feedback from the FDA regarding our perceived responsibility as an industry. However, the draft guidance published in January 2014 titled « Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics » appears to address pharma’s expanding role in engaging its audiences with promotional online activities, including what it can do with content after it’s been approved and published.

The FDA on real-time communications and interactions

The FDA makes an important, time-saving distinction in the draft guidance related to « real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts). » Due to the long lead time of internal promotional review, it realizes it’s impossible for pharmas to submit every new piece of content for review before publication. With the volume of material generated, the submission process would impede conversation and create a backlog for the reviewers.

« The FDA makes an important, time-saving distinction in the draft guidance… »

The FDA on promotional language

The FDA’s draft guidance recognizes product language as promotional even it is not physically connected to a product (e.g., a label on a bottle or package) and that the contextual relationship between a product and its labeling is the key. In the digital world, this means associations are made even if an item and its descriptor do not appear next to each other. Inference has always been an important focus for the FDA in reviewing promotional items – there have been many cases where the FDA discouraged a color scheme that links branded and non-branded material.

What you’re really responsible for

Next we get to the meat of the guidance: in short, if you own it, control it, create it, influence it (more about this in a minute), or operate it, then you are responsible for it. Clear, simple, specific. In prior discussions with the FDA, its representatives have been resolute on this point. If the FDA can ultimately prove that you knew about content you should be responsible for, it will insist you take responsibility for it.

« If the FDA can ultimately prove that you knew about content you should be responsible for, it will insist you take responsibility for it. »

The FDA on third-party site promotion

« Under certain circumstances, a firm is responsible for promotion on third-party sites. » The FDA clarifies this to be content focused: if you read and / or revise content for a digital venue, such as an advocacy resource like an organization’s Facebook page before publication, then you are responsible for the content and must follow the FDA’s standard procedures. Financial responsibility (such as providing a grant that enables the content to be developed) does not equate to content responsibility. This distinction is important because it means there is a growing opportunity for pharmaceutical companies to use existing healthcare communications – such as mobile health apps, health activist blogs and foundation sites – instead of building the digital venues themselves. This could be a real benefit to consumers and pharma by reaching the audience where they are already engaged and saving promotional dollars.

The FDA adds that although content submitted to these venues must be approved, how the third party uses the materials is not the pharmaceutical company’s responsibility. A great example (non-digital) is one from years ago when a TV news program that was integrating approved product messaging decided to shorten the program and deleted some critical compliance information. The pharmaceutical company was not held responsible, and the current guidance reiterates the FDA’s commitment to evaluate these types of circumstances independently.

The current draft guidance does state that employees or agents (vendors, agency partners) are responsible for publicly communicated product promotions. Therefore, pharmaceutical companies should clarify their internal employee social media guidelines. And, they need to take care when providing materials to health activists if there is any financial remuneration since the FDA will hold pharma companies accountable for the relationship. The FDA wants relationships clearly identified but is appearing lenient if there is no direct financially beneficial relationship with the company.

Overall, the recent draft guidance goes a long way to opening the door for pharma to participate in digital channels with user-generated content, provided there is transparency with the FDA all along the way. The draft guidance reduces many barriers to engaging in social media as a promotional vehicle, while highlighting the importance of being responsible for content you place, manage, or maintain, as well as the need for fully transparent relationships. It also puts a spotlight on the significant resources required to support the management of social media content; to many, it simply may not be worth the investment. That said, we hope to see the industry take advantage of the opportunity to develop deeper connections and support better health outcomes through these communication channels.

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