FDA Social Media Comments
I am excited about the launch of HealthCentral’s new blog. We will be covering a wide range of issues and are hoping to engage all those involved in online health in a serious and insightful discussion of the trends shaping our industry. I am HealthCentral’s General Counsel and will be blogging regularly here on legal and regulatory topics relating to online health and believe me there is a lot to talk about.
The major regulatory issue facing online health today is the anticipated FDA guidance relating to online pharma direct-to-consumer (DTC) advertising and social media. If you are reading this blog you are likely already familiar with the recent FDA Hearings on Social Media and Internet Promotion that the FDA held last November. The hearings generated a great deal of interest throughout the industry and included presentations from pharma and medical device companies, doctors, online health websites (including HealthCentral CEO – Chris Schroeder), search engines and patient advocacy groups.
The hearings were generally welcomed by one and all as an overdue acknowledgement by the FDA that the Internet and social media have become critical sources of consumer health information and present issues not addressed by the FDA’s existing regulations and guidance that speak to print and broadcast DTC advertising.
In the aftermath of the FDA hearings, I have been struck by how few of the interested parties have yet submitted written comments to the FDA. While the presentations at the hearings raised a lot of important issues, the time constraints prevented the speakers from getting into the details. Any guidance issued by the FDA will be shaped by its understanding of the Internet, social media, and the underlying technologies – which is not its core competency. That is why it is so important for advertisers and online health companies to weigh in now before policy decisions get made.
To be fair, the deadline for written comments is not until February 28th, 2010 and it may be that many others are still finalizing their comments. We have recently conducted survey research of our users on these issues and incorporated the results into our comments, which we will post on our site here. I strongly encourage everyone interested in online health to consider the questions posed by the FDA at the hearings (see here) and submit relevant data and insights to the FDA before Feb. 28th.