Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Building 51, Room 2201
Silver Spring, MD 20993

April 11, 2014

RE: Docket No. FDA-2013-N-1430

RE: Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

The FDA released draft guidance in January 2014 for interactive promotional media, calling for comments.  The Digital Health Coalition (DHC) congratulates the FDA on its release of this draft guidance and the invitation to comment.  Although we believe the current draft guidance warrants clarification of a few key areas and definitions, this kind of document and direction, especially with respect to responsibility, is exactly what the DHC, its members – and many industry stakeholders – have been awaiting with great anticipation. It’s the DHC’s view that any FDA guidance should have the positive effect of encouraging pharmaceutical companies to increase their level of participation in social media and promoting the flow of information, ultimately for the benefit of patients and the healthcare in general.  The essence of the DHC is a belief that regulated healthcare companies should endeavor to participate in social media as a means to promote public health, improve patient outcomes and facilitate productive patient/physician relationships (DHC Social Guiding Principles, 2012).

In the subsequent pages we will provide comments on the draft guidance in a number of areas; however, the most important subject matter in our view is “control” and “influence.”  While the draft guidance is clear that if a firm has control or influences a comment or action, then it is responsible for it.  The terms “control” and “influence” are quite subjective and interrelated, though not completely interchangeable. Since these terms can individually give rise to broad interpretation in various scenarios and are at the cornerstone of whether or not a firm is compliant or liable, further illustration of meaning of influence and control should be foremost of the list of revisions to the draft guidance.

 

INFLUENCE, CONTROL AND LIMITATIONS OF SCOPE

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FDA GUIDANCE:

A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.

In summary, regardless of financial support, if a firm has any control of, or influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements.

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Although “owned, controlled … operated by, or on behalf of, the firm” can lead reasonable consumers to a similar conclusion, it also seems rational that informed people can and will disagree about the definition of influence. By its nature, it is gray. What one person deems influence may be radically different than what another person deems influence. The future of digital health and innovation will certainly require additional clarity on this front.

So, what is meant by “influence” and how is that different from “control” and is there a difference between editorial control and simply “influence?”

The DHC leadership had the opportunity to discuss these matters with the FDA’s OPDP and brief them on the DHC Social Guiding Principles project in early 2012, as well as explain the thinking that went into the principles based on conversations with various industry stakeholders and DHC members.

https://digitalhealthcoalition.org/publications/social-guiding-principles/.

A disproportionate amount of time and energy went into the second principle of the DHC’s Social Guiding Principles, focused on the issue of defining “control”:

Regulated healthcare companies are deemed to “control” health and medical content if (i) it owns such health and medical content and has material editorial authority or (ii) it paid for the creation of such content and has material editorial authority over such content. (DHC Social Guiding Principles, 2012)

Perhaps the DHC’s approach to bring clarity to the subtle differences surrounding control (and influence) through the use of description by use of “material” and “editorial” could provide the FDA with further clarity and meaning to limitation of scope.

We all know when we see a situation free from any influence or control at all. However, as we move down the curve of “limited scope” with regard to influence the debate quickly spins out of control. An ambiguous phrase sitting on top of an unclear term leaves plenty of room for interpretation — and thus consequences — if a firm’s social media program is deemed to be aggressive and oversteps the invisible boundary. On the other hand, uncertainty and broad statements such as “even if limited in scope” could be just enough ambiguity to stifle innovation; thus resulting in unintended consequences for the patient.

We need more concrete examples when limited scope has been reached or materially breached– as well as examples of that limited scope on leading platforms such as Facebook, Twitter, and YouTube looks like. The FDA can’t provide guidance for every site and platform, but if we agree on basic standards and principled examples for the largest sites and platforms then the framework and thinking should apply to sites and platforms going forward. Realizing we do not live in a world of black and white, we do need additional and more concrete real-world examples of what “limited scope” with regard to “influence” means in practical terms to further foster innovation of interactive patient communication.  The DHC, and likely some of our members, is willing to partner with the FDA to identify such concrete examples and perhaps create mock-ups in a laboratory environment for further analysis and discussion.

QUESTIONS FOR FDA:

• One frequent question that we hope to see clarified in the final Social Media Guidance is related to the subject of submission requirements for interactive media: “if we
  

do not control the content, but we do control, influence or limit placement of the content, should it be submitted?”

It is common for firms and brands to place advertisements in content that is relevant to consumers or health professionals. For example, the ad may be placed in a section related to the condition or disease – but not intentionally placed against a specific article, specific comment, specific post, or specific third party content. This is an industry standard in media placement and treating digital any different than traditional media (where placement is directed to ensure relevance of surrounding and related content) is counter to the existing standards in place separating editorial from advertising today.

Furthermore, it is common practice that when a firm has an interest in placing promotional content online, they will provide limited direction with regard to the budget, the timing, the audience, the page placement, etc. Given this has been an industry standard across all media, would this “limited direction” be considered “influence” or “control”?

• Does controlling placement to avoid possible adjacent off label editorial content constitute control? Some could interpret the guidance to say “yes” but we believe this is not the intent of the FDA. For example, the current draft guidance puts companies in a difficult position when they seek to control ad placement so as to avoid being on sites or content with adjoining off label information.  In other words exercising control for the negative, i.e. not adjacent to relevant content, likely constitutes as much control as the positive, i.e. adjacent to relevant content.
• Does the act of posting a statement on a site such as Facebook, Twitter, or YouTube equate with influence and control of the site? A reasonable person would say “no” but we need more explicit clarity on this front.
• Does the ability to delete comments after they have been posted (on a site such as Facebook, Twitter, or YouTube) equate with control and review privilege?

 

RESPONSIBILITY FOR THIRD PARTIES (AND UGC)

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NEW FDA GUIDANCE:

A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.

That having been said…

FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.

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Although not a “green light” for most brands and marketers to proceed full speed ahead with social media and UGC, the current thinking and guidance provides much needed assurance that the FDA will not pursue third party UGC and comments on sites when control and influence are not present – even if those sites are owned or controlled by the brand or company. Of course we also have the caveat “will not ordinarily” as well as the disclaimer the “…the user has no affiliation with the firm and the firm had no influence”.

This guidance also presents a great opportunity to revisit one of the fundamental beliefs in the DHC Social Guiding Principles (referenced above). The DHC’s sixth principle is …

Regulated healthcare companies should endeavor to make reasonable efforts to correct misinformation that is factually incorrect.

Despite the fact companies are not held liable for comments and content from consumers with no affiliation with the firm and the firm had no influence on the UGC, we believe responsible firms with a long-term view of digital and social media will endeavor to correct misinformation in venues where they are active and engaged as brands and corporate citizens.

There are still open questions that the DHC’s membership would like to see clarified in the final guidance.

QUESTIONS FOR FDA:

• One area of focus that warrants additional clarification can be presented through a hypothetical scenario of “influence.”  For example, a firm enters into a contract with a healthcare professional, which later expires.  Post-expiration, the healthcare professional makes a statement that the firm would not support (and could be viewed as “off label”). With respect to this hypothetical situation, what is the intent of the statement “no longer under contract is not the same as not under influence”? Confirmation that “if an individual is truly independent then they are not under the scope of influence.”
• The draft guidance leaves uncertainty around blogger “influence” and opens questions about a firm providing a blogger with information or content, and the interpretation when the blogger’s posted content is not in line with the provided messaging.  For example, assuming the firm acknowledges its role and “influence” but lacks final “control” does the FDA want to review all of the materials provided and communications the firm had with every blogger? Confirm that if the firm can demonstrate that the blogger was provided with a fair and balanced presentation of materials (showing the firm’s intent to be fully compliant), then the firm would not be responsible for the blogger’s misrepresentation, regardless of influence.
• Is the firm responsible for anonymous non-compliant comments that are made by someone who may or may not be a company employee in social media?
• What exactly constitutes “employee or agent”.  What about the spouses/partners/family members or even friends of an employee? Is the firm responsible for their comments in social media? If so, in what situations would the firm be held responsible?
• With regard to submissions, what is the definition of an “active participant” in social media? How long must a firm monitor social media and report?
• Sites such as Facebook and LinkedIn often list employment information including companies, therapeutic areas (i.e. possible indications), and brands. Is the firm responsible for this kind of information when connected to employment activity?
• Consider the following scenario: a physician or advisor is hired by an advertising or communication agency – the agency is also engaged (for other work) by the pharmaceutical company. Is the firm responsible for comments posted online by the physician or advisor (contracted by agency)?

Finally, one critical point of any guidance is applicability in the real world.  It will be helpful for the DHC and its members, for the FDA to take as many practical and real examples of current social media tools and environments and run simulations on what this guidance could mean in each case.  To complicate things, there are innovations and new platforms coming out all the time and one could never be exhaustive about it without being dated months later, but such a detailed and joint exercise with industry and agency experts would be highly informative and would reveal the practical realities of this evolving guidance.  As stated earlier, the DHC would be pleased to work with the FDA and other partners in building such a “lab” to help ensure the guidance progresses in a manner and at a rate to be informative and protective for all parties involved.

Overall, we are pleased to see the FDA issue this draft guidance and spark public and industry discussion about the structure and how the guidance applies in the real world.  We thank the FDA for the opportunity to comment on the draft guidance and offer the Digital Health Coalition’s assistance in helping to resolve, provide supporting information or further clarify the questions its members have presented as part of our comments.

Kindest Regards,

Mark Bard, Co-founder DHC
Joe Farris, Co-founder DHC