Digital Insights: At Last: Potential FDA Guidance on Web 2.0 & Social Media
Without any clear-cut guidance, pharma companies have been struggling for years with how they will engage the drug industry on the web and via popular social media sites without violating FDA regulations.
By Michele Vaccarello Wagner, Senior Editor, Digital Media
With the Web 2.0 revolution, pharma and biotech companies have become more vocal on their own sites, pharma blogs and patient forums became all the rage and now it seems Big Pharma is having an easier time passing 140 characters or less on twitter through their legal department.
As the public has become increasingly reliant on the web for health information, companies, marketers and industry professionals have begged FDA to outline a guidance, and it seems as if FDA has finally seen the importance of their involvement.
On November 12-13, FDA will hold a public hearing in Washington DC on how drug companies are using the web and social media sites to discuss and promote pharmaceuticals.
FDA makes no promises for an established social media guidance but looks for industry collaboration, seeking specific company experiences and research data:
It should be noted that although a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue…The agency invites comment at the public hearing on the general concept of Internet promotion, positive or negative; on any aspect of Internet promotion that is of interest to the presenter…We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.
The hearing will focus on past controversial issues for Big Pharma such as how to handle adverse events reported on social media, acceptable levels of disclosure on relationships and endorsements and how to monitor third party communication.
Allowing users to contribute content or comment on a drug website attracts adverse event reports that must be filed with FDA so guidance is necessary to determine what is substantial for a report and what is misleading if drug companies do, in fact, allow community interaction on the web. Whether on company sites or blogs, facebook forums or twitter, brand teams have been hesitant to provide or respond to information out of lawsuit fears.
Any formal documentation that would allow pharma to embrace web conversation and social media is not just a small step for companies but one large step for a tight-lipped industry.