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RE: Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and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The FDA released draft guidance in January 2014 for interactive promotional media, calling for comments. The Digital Health Coalition (DHC) congratulates the FDA on its release of this draft guidance and the invitation to comment. Although we believe the current draft guidance warrants clarification of a few key areas and definitions, this kind of document and direction, especially with respect to responsibility, is exactly what the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In the subsequent pages we will provide comments on the draft guidance in a number of areas; however, the most important subject matter in our view is “control” and “influence.” While the draft guidance is clear that if a firm has control or influences a comment or action, then it is responsible for it.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or liable, further illustration of meaning of influence and control should be foremost of the list of revisions to the draft guidance.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
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.
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.
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