FDA

On September 25, FDA announced that they will hold public hearings on “the promotion of human and animal prescription  drugs and biologics and medical devices using the Internet and social  media tools” on November 12 & 13, 2009.

FDA is inviting everyone  “…all  interested parties, including, but not limited to, consumers, patients,  caregivers, health care professionals, patient groups, Internet  vendors, advertising agencies, and the regulated industry.”

The social media specially blogs, microblogs, social networks, video sharing, widgets and wikis are in its cross hairs.

The Agency is looking for views on the following 5 issues

1. For what online communications are manufacturers, packers, or  distributors accountable?

How to determine when third-party communications occurring on the Internet and through the social media technologies are subject to substantive influence by  companies that market products related to the communication or  discussion, when to treat it as sponsored speak as opposed to being independent.

This rings a bell. As I mentioned in  my blog post, FTC issued  guidelines covering the same issue of disclosing “material connection” between the person endorsing a product and the advertiser/manufacturer and the liability on both for non disclosure.

FTC also covered, to some extent, use of information, testimonials and endorsements by a non-company person using the social media channels.

2. How can manufacturers, packers, or distributors fulfill regulatory  requirements (e.g., fair balance, disclosure of indication and risk  information, postmarketing submission requirements) in their Internet  and social media promotion, particularly when using tools that are  associated with space limitations and tools that allow for real-time  communication

The problem is largely seen as the 140 character limitation on Twitter that may not be sufficient to present a balanced view of risks and benefits. Solutions for overcoming or circumventing the limitation of space  on Twitter or real time information overload will clearly open up new breed of innovation and  tools (not limited to Smartphone/iPhone apps only).

Drug and Pharmaceutical industry alone as at least 33 companies with revenues in excess of $3 Billions in 2008! Food manufacturing industries notched up sale of upwards of $500 Billion.

While expanding on this question FDA is inquiring how  companies will address the potential tsunami of  information shared on various social media sites in real- time that is continuously posted specially through Twitter Feeds and mobile applications.

3. What parameters should apply to the posting of corrective  information on Web sites controlled by third parties?

The cause for this concern is rooted in “misinformation” or incorrect information that is floating around in blogs, reference sites, forums and wikipedia’s of the world. Sometimes companies, even when they know that the impugned unit of information is wrong, shy away from corrections for the fear of being held responsible for the entire content on the site.

4. When is the use of links appropriate?

FDA is interested in knowing how hyperlinks from branded (approved)  sites to sites with unbranded (read unapproved) products should be handled. Also conversely how the issues in using unbranded URL leading to a site with branded products should be handled (Micro-sites!!)

5. Questions specific to Internet adverse event reporting

How are companies that bear postmarketing reporting responsibilities using the Internet and social media tools to monitor adverse event information about their products?

FDA, like other Government Agencies, uses Twitter for disseminating Drug Info (2429 followers) and  Product Recall information (13168 followers).  One tweet monitoring service has reported 5756 feeds (Oct 7, 3 PM PST).

Way to go!