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were specifically interested in the content related to digital healthcare marketing and the FDA’s recent Social Media Draft Guidance.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 While FDA representatives covered a myriad of topics, the content related to the recently released Social Media Draft Guidance is of particular interest to the Digital Health Coalition.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The current Social Media Draft Guidance was then reviewed by Barbara Chong, PharmD of OPDP.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:
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:
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 The draft guidance gray areas on the subjects of “influence” and “control” were repeatedly referred back to the concept of the firm’s “intent”.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 Christine@digitalhealthcoalition.org.