All Really Depends…On Intent
Summary of the February 27-28, 2014 DIA Pharmaceutical Marketing Workshop
By Christine Franklin, DHC Managing Director and Joe Farris, DHC Co-Founder
Last week’s 25th Anniversary event of the Drug Information Association’s (DIA) Pharmaceutical Marketing Workshop did not disappoint. Digital Health Coalition representatives in attendance were specifically interested in the content related to digital healthcare marketing and the FDA’s recent Social Media Draft Guidance. It is with pleasure that we are able to provide our members with a review and summary of the proceedings.
The DIA’s February 27-28th event is relevant to the DHC membership and is generally remarkable for the series of presentations and panels with representatives from the FDA’s Office of Prescription Drug Promotion (OPDP) division. While FDA representatives covered a myriad of topics, the content related to the recently released Social Media Draft Guidance is of particular interest to the Digital Health Coalition. First, OPDP Director, Tom Abrams, provided an overview of current initiatives, including confirmation that OPDP is currently working on additional guidance in the topics of “space limitations” and “correcting misinformation.”
The current Social Media Draft Guidance was then reviewed by Barbara Chong, PharmD of OPDP. Chong outlined the known facts of the Guidance, such as:
- The Agency considers whether the firm, or anyone acting on its behalf, is “influencing” or “controlling” the promotional activity or communication
- The firm is “responsible” if the firm collaborates on or has editorial, preview, or review privilege over the content
It seemed clear from the presentation that the concept of “influence and control” encompasses a broad definition for OPDP. However, genuine uninfluenced “user generated content” was again confirmed as not the responsibility of the firm (and firms should be disclosing all involvement – more on that theme to follow).
After presentations by Chong and Abrams, audience members were able to ask direct questions (or submit anonymously), which led to some clarity on the most commonly scrutinized sections of the guidance. What follows are Q&A highlights from both a morning session and an extended Q&A on the afternoon of the 27th, moderated by Lucy Rose, regulatory expert and former DDMAC director:
- Advance knowledge in the absence of “influence” does not equal responsibility and would not require a submission. Director Abrams indicated that OPDP is willing to dedicate additional resources to address the nuances of “advance knowledge” vs “influence” as needed.
- “Directing Placement” was included in the draft guidance because of concern over influence of placement (which could allow a firm to make false or misleading claims).
- Resubmission is required if a third-party site where firm is advertising (Facebook etc) changes the platform structure, thus impacting how the placed ad appears.
- One asked-but-not-answered question that we hope to see clarified in the final Social Media Guidance is of particular interest. On the subject of submission requirements for interactive: “if we
don’t control the content, but we do control or limit placement, should it be submitted?”
“intentionally placed” is equivalent to a claim; however – in the event that an ad shows up unintentionally on a site despite the firm’s best efforts to control otherwise (considered a “lucky hit”) – the Agency would need an explanation. A repeated pattern of “lucky hits” would yield further explanation and justification.
A second area of focus that needed additional clarification was presented through a hypothetical scenario on “influence.” The example posed that a firm enters into a contract with an HCP, which later expires. Post-expiration, the HCP makes a statement that the firm would not support (and could be viewed as “off label”). The response from OPDP was “no longer under contract is not the same as not under influence. FDA cares about influence.” This issue was later probed and OPDP clarified, “if an individual is truly independent then they are not under the scope of influence.”
The uncertainty around blogger “influence” was probed at length during both Q&A sessions. The questions centered on the idea of a firm providing a blogger with information or content, and the blogger’s posted content is not in line with the provided messaging. The firm acknowledges its role and “influence” but a lack of final “control”. The resulting clarification from OPDP indicated that in that scenario, the Agency would want to review the materials provided and communication the firm had with the blogger. If the firm can demonstrate that the blogger was provided with a fair & decent presentation of materials (showing the firm’s intent to be fully compliant), then they would not be responsible for the blogger’s misrepresentation.
Two overall themes most relevant to Digital Health Coalition members emerged throughout the event (and the Q&A sessions). The first can be summarized as an often-used phrase heard from the podium “It depends… on the intent”. The draft guidance gray areas on the subjects of “influence” and “control” were repeatedly referred back to the concept of the firm’s “intent”. As intent is not necessarily measurable or discernable when reviewing a final ad/blog post/facebook page etc, the Digital Health Coalition urges all involved parties to document, document, document… and when in doubt, document further. In the event OPDP becomes aware of concern over a firm’s or brand’s presence in social media, OPDP will be looking to background materials to demonstrate “intention..” Assuming a firm can provide evidence that it acted with the intention to be compliant and demonstrate a pattern of intention, they should not be considered responsible for activities beyond their control.
The second major theme of focus for attendees concerned with the draft guidance centered on the question of “placement.” Unfortunately, on that point, there wasn’t additional clarification and there is not any further consensus. Attendee questions focused on the concern that the current draft guidance puts companies in a difficult position when they seek to control ad placement so as to avoid being on sites with adjoining off label information. Industry experts agree that there will need to be additional clarification on the topic in the final guidance. We anticipate that this topic will be a focus of much of the comments produces in response to the draft guidance and certainly a part of the DHC’s response.
The Digital Health Coalition was fortunate to be represented and in attendance at the DIA Pharmaceutical Marketing Workshop. It was a great opportunity to review the draft guidance with the individuals who authored it, and to highlight some of the areas of concern raised by our members, especially as we launch our new virtual forum where we plan to continue the conversation with the membership and organize our response to the draft guidance. We look forward to continuing to gather and summarize industry feedback from our membership, ultimately providing a unified voice back to FDA. If you would like to participate in that feedback process or join us in our virtual online forum, please contact DHC Managing Director, Christine Franklin, via email at [email protected].