The stunning news of the week has been that the Food and Drug Administration is finally doing what it should have done long ago and called for a Part 15 hearing on social media. A Part 15 meeting is an effort to gather information from stakeholders. For those who can't attend, a docket is opened.
- For what communications are manufacturers, packers or distributors responsible?
- How can manufacturers, packers or distributors fulfill regulatory requirements (i.e., 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 communications (e.g., microblogs, mobile technology)?
- What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
- When is the use of links appropriate?
- Questions specific to Internet adverse event reporting. How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?
There are many with a stake in these questions. Obviously all medical product manufacturers. But also the advertising industry, the public relations industry, the search engines that sell ad space, physicians and consumers themselves. Needless to say, how industry responds to these questions is of incredible importance and may be one of the most important strategic considerations in medical product communications for the decade. The stakes are just that high.
- Consider the current competitive landscape;
- Have carefully reasoned internal social media guidelines and policies;
- Have developed strategic visions for what they ideally would like to accomplish in the new and social media spaces, not just a collection of one-off tactics;
- Develop a point of view about social media and its ability to promote and support public health ends as well as a means to marketing products (that may be the most important point and one on which I have a lot of thoughts)
- Think beyond what companies "can't do" and think about what you should be doing in an ideal world that includes your participation in social media;
- Move beyond the status quo of what is traditionally acceptable in your thinking;
- Do not plan in silos – this must be strategic planning that goes cross-disciplines – a response written by MedReg that does not include communications will be a big mistake;
- Ad, take each question and message out responses that are clear, consistent and that articulate a systemic vision, not a piecemeal approach to provide answers. It is very important that you see this holistically.
That is what individual companies should be doing. The associations of medical product manufacturers, such as PhRMA and AdvaMed also have to carefully craft their approach to demonstrate that their industries in fact do have a vision and one that does support a wider agenda than marketing, but that includes genuine efforts to promote sound public health policies.
After the public meeting, the FDA will digest this information and will develop a draft guidance. At the FDLI conference held earlier this week in Washington, both Dr. Janet Woodcock and Tom Abrams affirmed that this is a priority for FDA. The scheduling of this meeting is a two-sided coin – on the one hand, there is a tremendous opportunity to help shape policy around the way industry and consumers can communicate; on the other hand, done badly, it will create yet one more obstacle not only for better marketing and bringing industry into an arena where patients are seeking more healthcare information than any other source, and may even result in the unintended consequence of impairing rather than supporting public health.
Eagerly awaiting your comments on google’s new “sidewiki” tool-bar add-on.
Now anyone can annotate (or deface, depending on how you look at it) any site on the web.
Great summary of the Notice and set of suggestions on how to respond. Using it with an upcoming meeting. Thanks.