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A Call To Action: FDA, Social Media and Physician Engagement

Joel Selzer (LinkedIn profile), my Co-Founder at Ozmosis, has spent the past few weeks following the buildup to the FDA's Public Hearing on Social Media. After digesting last week's testimony and the conversations around it (visit www.fdasm.com for the latest courtesy of Fabio Gratton), Joel offers the following:

During my recent presentations at Digital Pharma and AdvaMed's Social Media Seminar, I argued that social media offers pharmaceutical and medical device brands a unique opportunity to engage with physicians. According to Mark Bard from Manhattan Research, 70% of physicians want pharmaceutical firms to engage them online and 60% of physicians either use or are interested in using physician social networks (just ask the docs on Ozmosis or Sermo). With thousands of physicians actively using social media every day to access and share medical information (see Rohit Bhargava's post on "How Doctors Are Using Social Media", one would expect pharmaceutical and medical device firms to salivate at the engagement possibilities.

Yet, both industries have been reluctant to engage doctors using social media under current FDA guidelines. Their reluctance has been disappointing to many but should not be surprising. Michele Sharp of Eli Lilly said it best at the FDA hearing:

To date, Lilly has avoided significant interaction with healthcare professionals and patients about our products in social media forums – largely because of a lack of clarity in understanding FDA’s expectations as to how we could participate and comply with FDA requirements.

This theme was reiterated throughout the hearings, and its absolutely critical that the FDA evaluate the impact of not providing guidance. Michele Sharp also nailed it when she called on the FDA to lead a series of public workshops that could, "collectively generate ideas, leverage the knowledge, expertise and experiences of the participants and work toward viable solutions, so that FDA can provide the detail and clarity to the pharmaceutical industry and others through Guidance or executive channels."

Lilly's recommendation is spot on, but in addition to immediately scheduling a series of public workshops…the FDA should appoint a Social Media Advisory Panel (a recommendation echoed by Zen Chu of Accelerated Medical Ventures). While holding the public hearings was a great step forward, the FDA needs to augment its social media expertise and it needs to do so quickly. Its clear from last week's testimony that the FDA has a lot of homework piling up and the best way we can accelerate their education is to demonstrate two very important points about social media use to the FDA.

1. Physicians and industry are already working together
2. Practical solutions exist to address the FDA's concerns

To date, a few brave souls have started to dip their toes in the social media waters. For example, Medtronic has sponsored training videos for surgeons on OrLive, Novartis runs a virtual physician advisory board called the PCP Heartburn Advisory Board, and AstraZeneca has partnered with the American College Gastroenterology to launch ACG GI Circle, an online interactive community built for ACG members.

While I applaud each of these initial social media efforts, they represent only a fraction of the possibilities social media offers. If used appropriately to educate physicians and provide more effective customer support in a trusted and transparent fashion, we can engage physicians more effectively and help them to deliver better patient care.

In Europe, Boehringer devised an online promotional campaign for Asasantin Retard on the doctors' online community doctors.net.uk. Over the 12-month campaign period product sales increased by over 15% and there were 27,000 online doctor interactions. The campaign was so successful that it won a PM Society award in January in the interactive digital category. If we want to see similar success here in the U.S., we simply cannot sit back and bury our heads in the sand while the FDA spends the next 12-36 months drafting official social media guidelines.
Instead, Eli Lilly and every other pharmaceutical and medical device firm needs to step up to the plate. Don't wait for the FDA. While the perceived risk of receiving a warning letter may haunt your dreams, the greater risk may be that of inaction. This leads to my second point. What happens, if, in the absence of practical solutions around AE reporting and off label discussions, the FDA misjudges the real risks and severely limits your ability to engage physicians through social media or other online channels.

Let's imagine an online world where physicians have questions about your products that go unanswered. This never happens, right. Or even worse, they have no idea your new product or indication has even been approved. Is this good for the practice of medicine? No. Is this good for product sales? No. Is this happening today? Yes. Physicians are already discussing your products and asking questions (Pfizer made this point at the hearing), and for the most part, brands are not part of the conversation. Yet, I know that numerous brand teams and their agencies desperately want to engage, but due to fear and uncertainty around regulatory concerns you find yourselves sitting on the sidelines. Can you really afford to sit back and wait another 12 to 36 months only to learn that the FDA guidelines offer no real guidance or worse, they restrict all the innovative and creative programs you were hoping to launch?

So don't wait. Begin working today on developing and implementing practical approaches to mitigating your risk and demonstrating the value social media programs can provide. For example, Adverse Event monitoring and reporting can be controlled and even automated, especially in "physician only" social media sites. Jonathan Richman of Bridge Worldwide, has a great post on the real number of reportable adverse events. Off label discussions can also be appropriately handled. The processes and technology to support both are not science fiction they already exist in the real world of social media. If we work together to take action, we can make a difference for patients and physicians that the FDA cannot ignore.

Joel Selzer Co-Founder & CEO Ozmosis, Inc.
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