In the age of new media, sharing information about a prescription drug is even more perilous than ever. Despite promises of guidelines in 2009, the FDA still has yet to issue clear guidance to pharmaceutical companies about how to remain in compliance with regulations while using the appealing and affordable medium of new media to disseminate information.
In their panel, “Talking About Your Product in the New Age: Social Media and the Internet,” moderator John Kamp, along with David Adams, Partner, Venable, LLP; Raymond Kerins, Vice President, External Affairs and WW Com., Pfizer; Michael Myer, President, Palio; George Ng, Partner, Co-Chair of Life Sciences Practice, Gordon & Rees LLP discussed current standards and policies and liability for companies in the new media age.
In short, all panelists agreed that companies needed to expect extreme vigilance by the FDA, and use caution when considering how, and how much, to share and interact on social media, particularly when it came to off-label use of prescription drugs.
The panel had some practical tips for companies considering how, or if, to use new media to communicate information about products.
• Assume vigilant FDA
• Apply traditional standards on company sites
• Exercise caution when participating on third-party sites
• Consider product liability concerns regarding correction and adverse event reporting
George Ng advised creating a comprehensive social media strategy that included tactics to manage all of the above, and clearly defined how and where your company would participate in social media. The plan should answers to questions such as:
• Is this advertising and marketing?
• Who is the intended audience?
• What should I consider with this audience with respect to regulatory requirements?
• What mechanics will I use to regulate access to that audience?
• What is the sponsor’s tolerance for uncertainty and risk?
• How do I align the site with this tolerance level?
• What are the regulatory consequences of adding or linking other tools or content to my site?