For many in the medical industry, November 12 can’t come soon enough. It’s the date that kicks-off a two day FDA hearing on the promotion of FDA-regulated medical products on the Internet and through social media tools. In order to make the best of this opportunity, which many in the medical community feel is overdue, it is imperative for pharma, medical device, PR, advertising, digital and search engine optimization companies to conduct their due diligence in understanding exactly what’s at stake.
By scheduling a Part 15 hearing (a Part 15 hearing is an effort to gather information from key opinion leaders), the FDA has entrusted its stakeholders to offer their insights into the increasingly complex digital landscape. Medical companies, and the marketing and communications agencies that support them, will have the opportunity to directly influence how the FDA ultimately decides to regulate platforms like Facebook, Twitter and the blogosphere.
The FDA has centered the hearing on five main questions in which they are interested in receiving feedback:
1. For what online communications are manufacturers, packers, or distributors accountable?
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 communications (e.g., microblogs, mobile technology)?
3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
4. When is the use of links appropriate?
5. 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?
If you’d like to register to attend:
1. Visit the Regulations.gov page specified for this meeting: http://tinyurl.com/yaqvmpt
2. Click “Submit a Comment” and type that you are interested in attending
3. Complete the information boxes
4. A tracking number will then appear on screen as your confirmation
Registration is on a first-come, first-served basis and it closes this Friday. The FDA will then notify those selected to attend.
Our digital team at Spectrum has submitted a request to attend the hearing. The information presented in November will directly impact our work moving forward and we are excited to work with our colleagues in the health space to ensure that digital platforms remain a viable promotional tool for medical companies. Continue to check the Full Spectrum Blog for FDA updates as the hearing approaches!
Tags: FDA
[...] US partners in GLOBALHealthPR, Spectrum, have put in request to attend the hearing. Team Aurora will keep you posted on how the story unfolds – maybe we might even get a guest [...]
We look forward to you keeping us updated on this important issue. We are going through something similar here in the UK (although maybe not as far reaching as this FDA process). I have made a comment on our own blog that getting clear guidance on the use of digital media will increase the transparency and credibility of our communications on behalf of the pharmaceutical industry. Which I believe can only be a good thing. It is great to see a fellow GlobalHealthPR partner agency leading the battle cry on this topic.