Research Analyst, Cutting Edge Information
The ePharma Summit 2012 kicked off with a full day of symposia on three tracks. I attended the Medical, Legal and Regulatory Policy Summit, and as I write this, my head is swimming with interesting facts, perspectives and best practices from the day’s presentations.
The first half of the day offered opportunities to hear from senior pharma personnel in the Medical, Legal and Regulatory Affairs (MLR) departments at companies ranging from Top 10 to mid-sized. The second half of the day featured a summit within a summit, as the Digital Health Coalition led a host of short, rapid-fire sessions that covered the legal, regulatory, agency and vendor angles as they apply to the DHC’s Social Guiding Principles. This latter portion ended with a panel discussion in which Peter Pitts of the Center for Medicine in the Public Interest moderated a discussion ranging from the president of a patient advocacy group to the head of global digital marketing at Roche. Talk about information overload. So before I start forgetting everything, here’s a brief recap of the day’s sessions.
Lucy Rose, president of Lucy Rose Associates, despite being under the weather today managed to adroitly moderate a series of five sessions addressing the MLR perspective on digital marketing, social media and mobile media. The first session featured Joanne Curley, a director of regulatory affairs for Shire, who was filling in at the last minute for a colleague. The lack of preparation time didn’t stop her from delivering an informative take on how Shire addresses digital marketing from the reg affairs standpoint. Among her observations were the four most important questions that a reg affairs department faces when dealing with digital marketing:
1) How do you ensure appropriate balance of efficacy claims and risk information?
2) How do you include important context for claims when space is limited?
3) How do you keep branded content separate from inappropriate surrounding content?
4) How do you leverage additional functionality (i.e. sharing, commenting, etc.) in promotion and remain compliant?
The answers to these questions obviously vary from situation to situation, but for a marketer looking to push something through review, they should be prepared to have the answers to these four questions ahead of time. Among the other highlights of the Curley’s session were the implications of mobile formatting on regulatory compliance, the non-existence of the one-click myth, and the role that Shire’s multi-disciplinary social media team plays in improving the compliance of digital initiatives.
Mobile medical applications and last year’s FDA guidance on the topic of what is and is not considered a mobile medical device was the subject of Novartis’ Jack Scinnelli’s session, providing an encapsulation for marketers of what the agency plans to regulate.
One highlight of the morning session was a slideshow by Paul Savidge of Bristol-Myers Squibb. In it, he helped explain the December 2011 draft guidance on responding to unsolicited requests for off-label information. Using characters (and, I assume, music) from the hit silent movie The Artist, he told the story of the FDA, played by the dashing leading man, and industry, played by the lovely heroine, as they talk about the first guidance to acknowledge the existence of social media. I asked for a link, but as of yet I don’t have one. When I get it, I’ll be sure to post to the ePharma Summit blog as soon as humanly possible. It was creative, informative, at times very funny, and ultimately a very engaging way to describe the pretty dry material the FDA usually provides.
After a Q&A session and lunch (in which I regrettably ordered The Reuben from the Carnegie Deli – seriously, have you seen it? It must weigh three pounds), Digital HealthCoalition co-founders Mark Bard and Joe Farris led a lively afternoon session that opened with the unveiling of the nonprofit’s Seven Social Media Guiding Principles. Here they are:
1) 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.
2) Regulated healthcare companies are not responsible for user-generated content online that they do not 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.
3) Regulated healthcare companies have a responsibility to report adverse events they become aware of. Regulated healthcare companies should follow the existing adverse event reporting rules in place at the FDA.
4) Employees of regulated healthcare companies should disclose their material company relationship when posting comments/content or engaging in an online conversation relating to a company product or relevant healthcare issue.
5) Regulated healthcare companies should endeavor to respond to questions on sites they control within a reasonable period of time, and to implement reasonable measures to enable timely responses to crisis and emergency situations.
6) Regulated healthcare companies should endeavor to make reasonable efforts to correct misinformation that is factually incorrect.
7) Regulated healthcare companies should endeavor to appoint employee(s) tasked with the role of “patient liaison” focused on representing the best interests of the patient online.
The rest of the afternoon saw several presenters apply these principles to various issues facing digital marketers and healthcare communications in general. Mark Gaydos of Sanofi offered another regulatory perspective, and provided some salient counterpoints that marketers need to address, such as how to preserve prominence in mobile presentations and whether or not platforms like Twitter can ever really be a promotional tool, given its character limits. David Ralston of Gilead Sciences described some of the alignment and non-alignment between what the DHC’s guiding principles describe and what the FDA’s off-label guidance address, noting that for a number of principles there was a good deal of synergy. He also pointed out, however, that the guidance does not provide safe harbor to a pharma company to correct misinformation, one of the core tenets of the DHC’s proposed guidelines. A panel of vendor representatives offered insight into what is happening in the world of social listening, and Melissa Davies of NM Incite described a shift in the underlying philosophy behind her pharma clients’ motivation to gather social listening data, saying that more and more, she’s seeing clients look for not just data but insights (i.e. what does the data tell us about consumers and what they are looking for?).
Michael Myers of Palio offered an engaging session of case studies on the best and worst in pharma-initiated social media. He pointed out that some of the hardest falls have occurred at the companies making the biggest strides, illustrating how the industry, if it is to move forward in social media, will need to accept that mistakes will happen, and that ironically, social media allows those companies to rectify and correct those mistakes with unprecedented alacrity.
John Patten of Facebook presented on the wondrous reach of the social media giant and pointed to examples of how pharma has been able to successfully negotiate a presence on the medium. Among the highlights of his session were the revelation that the new personal timeline aesthetic would soon be rolled out to brand pages, as well as the impending implementation of advanced admin features that would allow, among other things, a pharma company to directly message an individual who posted inappropriate/non-compliant content on their walls, thereby offering the industry a way of mitigating a previously uncontrolled risk.
The day wrapped up with Peter Pitts’ assessment of the off-label guidance, in which he offered a frank assessment of what the document does and does not do well, including the curious insistence on refusing to acknowledge that brand.com pages have the most compliant, up-to-date information possible on products. He then moderated a panel discussion in which the theme of the day was summed up: digital marketing can and will continue to gain momentum, but pharma needs to begin accepting that social media will likely never offer it the promotional avenue it seeks, but rather should be viewed as a way of gathering market research, providing needed accurate medical information about their products and fostering consumer trust through unbranded initiatives.
The slide shows from the day’s presentations are not yet available, but I've been assured they will be in the coming days or weeks via the ePharma Connect web portal available on the conference homepage for those attending the event.