Folks, if we choose to believe its true, 2014 looks to be the year that FDA will deliver on those promises.
In December 2011, FDA issued draft guidance for responding to unsolicited requests for off-label information. Then this January, they released draft guidance on 2253/2301 submissions of social/user-generated content. The document focused on the protocol for submitting form 2253/2301 for both owned and third-party user-generated or “realtime” content. But it also revealed what the FDA considers its regulatory domain and illuminates what the FDA is most concerned about enforcing in this arena. It also helped explain when manufacturers are responsible or accountable for promotional content, taking into consideration the source of the content and the level of influence/control.
Now we’ve learned from RAPS that CDER has published its guidance agenda for 2014, and on the agenda are three additional social media-related documents:
- Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
- Internet/Social Media Platforms: Correcting Independent-Third Party Misinformation About Prescription Drugs and Medical Devices
- Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links
As a reminder, the five questions to which FDA asked the industry to respond during the November 2009 Part 15 hearing included:
- Accountability. For what online communications are manufacturers, packers, or distributors accountable?
- Space limitations. 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)?
- Correcting 3rd-party information. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
- When is the use of links appropriate?
- AE reporting. Questions specific to Internet adverse event reporting
Let's look at those questions again and the progress against them:
What happened to guidance on AE reporting? I'm not sure, and it's interesting because -- right or wrong -- AE reporting responsibilities tend to be one of the biggest red flags to pharma companies looking to participate in social media.
AE's aside - according to multiple reports and if we choose to believe it is true – it looks like in 2014 FDA will fulfill the hopes and dreams of pharma marketers everywhere and make participating on social media crystal clear.
Then again, maybe we shouldn’t believe everything we read on the Internet.