Amplify: Healthcare and Social Media
Check out our report on the role of social media in healthcare, as published by Porter Novelli international. Click the link below to access the full report on the Part 15 meetings held by the Food and Drug Administration (FDA) in the United States.
In November 2009, the FDA held a Part 15 meeting on the implications of the Internet and social media.
Unlike a FDA advisory committee meeting, where the agency's position is made known via information packets, where questions are asked and votes taken, a Part 15 hearing is for listening and gathering purposes. No regulatory action is required after the meeting is over. This led to cynicism in some circles that the meeting would lead nowhere and was, in fact, an excuse in lieu of more serious regulatory excogitation. Those Doubting Thomases were in for a surprise.
The FDA designed an aggressive and robust docket of 70 presentations over two days featuring presenters from the worlds of public health, communications, regulatory law, Internet technology, the blogosphere, the pharmaceutical industry, social science, and both patient and consumer advocacy. Among those testifying was Peter Pitts, global lead for Porter Novelli's healthcare practice.
In his report, Pitts predicts the FDA to issue guidance sometime in late 2010 or early 2011 that focuses on three issues:
1.The range of adverse event reporting responsibility, where reactions or side effects are reported to the FDA for cataloguing and consideration
2.Ways to make MedWatch more visible (even to the degree of mandating prominent display of a MedWatch icon on print and broadcast advertising, promotional materials and online). MedWatch is the FDA programme for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.
3.The creation of 'safe harbour' parameters to allow (and hopefully, encourage) regulated industry to correct misinformation on the Internet.
Where will this all lead? According to Pitts, there is much work to do and it's too important not to do it right. But he also argues it's not an excuse to do nothing - the fear of many in the healthcare industry. The FDA docket closes in February. After that, the Division of Drug Marketing, Advertising and Communications will review all the materials - and there will be a lot of material to be reviewed by a pretty spare DDMAC staff. That will take time. Then the FDA will have to decide what - if anything - it wants to do. And that also will take time. So what will we see and when will we see it? Pitts isn't sure, reminding that the FDA operates in FDA time ("the time it takes to get it right") - almost the opposite of social media time, immediate gratification.
Read the full report.
Download the pdf: Health_and_social_media