Bryan Person's Blog

Earlier this week LiveWorld CEO Peter Friedman (@PeterFriedman) submitted comments to the Food and Drug Administration (FDA) around best practices in social media for healthcare and pharmaceutical companies. 

The FDA had been seeking and accepting public response since holding its 2-day hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools last November.

Here are the highlights of our recommendations to the FDA, which can be downloaded as a PDF or read as an embedded Sribd file below:

1. Confirm Federal Communications Decency Act of 1996 as 'safe harbor'
"The FDA should confirm that the CDA (Federal Communications Decency Act of 1996) applies to pharmaceutical companies just as it does to all other web site operators in any industry, including that website operators have a safe harbor under which they are not liable for user content posted on their sites..."

2. Provide moderation best practices guidelines
"The FDA should required that pharmaceutical companies provide moderation of the social network sites they operate, but rather than regulate specifics, provide best practice guidelines.

"The moderation can be provided by the company itself or by 3rd-party vendors that the company has approved. The specifics of the moderation (including types of moderation--pre-screening or post-screening--volume of moderation and time coverage, and how all of that applies to different types of content) are to be determined in the reasonable judgment of the company.

"We specifically do not recommend that companies be required to pre-screen all user content before displaying it on their sites. Consumers in most markets are now accustomed to their content appearing on a site immediately and being post-screened. If companies are regulated to a pre-screen only environment, the resulting lag time (many minutes, even hours) for content
to appear will cause their online communities to have weak dynamics, and consumers will head to other venues  ..."

3. Create "reasonable adverse event escalation procedures'
"Studies ... suggest that very little user content in [social networking and online community] site meets the four elements required for reporting an adverse event. This is also our experience in healthcare online communities.

However, "[d]ue to the medical impact nature of pharmaceutical products, the FDA should require pharmaceutical companies to establish and manage reasonable adverse event escalation process for the sites they operate, including social network/online community websites. This would include ...

"a) Posting of types of potential side effects ... on a web page in a clear, understandable mannder.

"b) A venue for end users to report adverse events, such as a self-reporting form.

"c) Adverse events escalation process that maps into the company's standard adverse escalation process.

"d) The FDA also should clearly state that due to the dynamic and subject nature of user content, even with a formal adverse events escalation process, the company cannot be expected to and will not be held legally liable for 100% coverage and accuracy in that process."

Download PDF of LiveWorld's public comments to the FDA

For a repository of responses submitted to the FDA, visit this FDASM Comments page.