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FDA Framework for Regulating Social Media Promotion

On March 16th, Ozmosis submitted its comment to the FDA's docket on the promotion of regulated medical products using the internet and social media, joining over 150 other submissions by drug manufacturers, health systems, consultants, agencies, advocacy groups, and private individuals.

The level of interest in this subject should surprise no one.

The world of medicine has changed dramatically since the FDA's last hearings on internet use. In 1999, less than 50% of physicians used the internet for professional purposes. Today, Google reports that virtually all physicians (92%) use the internet to gather medical information in a clinical setting, and according to Manhattan Research, 89% of U.S. physicians now describe the web as "essential to their professional practice." With the groundswell for social media resources among physicians continuing to rise, Manhattan Research also shares that 71% of U.S. physicians are interested in or already use physician social networks for peer-to-peer interactions.

However, many pharmaceutical manufacturers hesitate to engage with physicians through social media due to the uncertain regulatory landscape. While there have been notable exceptions, as highlighted in our FDA comment, this missed opportunity is a detriment to patients, providers and manufacturers alike. We strongly encourage the FDA to provide clear guidance to avoid further delay.

So what would appropriate guidance for manufacturer participation look like? At Ozmosis, we have established a set of principles that, if applied to the broader web and social media landscape, would be to the benefit of manufacturers, physicians, and patients alike.

On Ozmosis, physicians use their real identities and share their professional affiliations, resulting in a more trusted and transparent exchange of clinical information. Since physicians always know with whom they are communicating and sharing knowledge, the insights and discussions that take place on Ozmosis are highly valued and insight rich. Any regulatory framework put forth must ensure the same level of trust, transparency and accountability our physicians already benefit from every day.

In such a framework, manufacturers who elect to interact with physicians online and through social media would have specific responsibilities to:

Included in our comment is an analysis of the recommendations submitted by PhRMA, Abbott Labs, AstraZeneca, Bayer, Eli Lilly, Genentech, Johnson & Johnson, Merck, Novartis, Pfizer, Sanofi-Aventis, and Sepracor (download all comments at FDASM) that shows pharmaceutical manufacturers by and large accept these responsibilities.

If, by adopting these standards, manufacturers receive broad latitude to communicate with patients and physicians online, the net effect on the availability of online medical information and the conversations that surround them will be positive. All parties, including patients and providers, stand to benefit. As the internet becomes more open, social, and delivers real-time services, manufacturers and physicians must have the leeway to participate in the online conversations taking shape around medical products.

In subsequent posts, we will provide additional insight into how manufacturers can fulfill these responsibilities.

Joel Selzer

Co-founder & CEO, Ozmosis

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