After two years of waiting, FDA issued the first in a series of planned guidelines on social media, at the tail end of 2011. But the document said less about what pharma can and cannot safely say and do with social media than about what the agency's response should be to unsolicited requests for off-label information. Details of the guidelines were reviewed in the Jan. 3 http://www.pharmexec.com/ blog post, "Off-Label Comments Online: Keep Doing What You're Doing, Says FDA." Based on the reaction Pharm Exec received from the following experts—PhRMA is preparing its public comment for the Federal Register, and declined to weigh in—the guidelines seem to have missed the forest while focusing on a single tree.
Bill Drummy, CEO, Heartbeat Ideas:"The FDA hinted last year that it would eventually be offering 'guidance' regarding social media and the use of the Internet. So now that they have taken more than two years to think about it, they have published their first 'guidance,' which amounts to this: 'Follow the offline rules and use your common sense.'
Is this helpful? I suppose some guidance is better than none. But I doubt it will have much impact on the industry, because these kinds of inquiries are relatively infrequent; the guidance is pretty much what any internal med/reg/legal group would have advised anyway. And it fails to address the much larger issues regarding social media that are likely to have the greatest impact on public health.The FDA is acting irresponsibly by being so slow and timid in advising the industry it monitors; it is not advancing its mission of protecting the public's health, and by not advancing that mission, it is actually putting health at risk. The larger issue here (and the real threat) is that the FDA has proven itself incapable of keeping up with the speed of the digital era. It seems to have neither the will nor the capacity to do its job properly when it comes to the Internet."
Dale A. Cooke, Vice President/Group Director, Regulatory Review, Digitas Health:"The FDA didn't issue guidelines for using social media; the FDA issued guidance about how it sees existing regulations applying to one specific issue. And within the discussion, they incorporated social media, just as consumers and healthcare professionals have incorporated social media into their everyday interactions. It's a major step forward for FDA and will absolutely move forward the integration of social media into communication plans by industry.
The most important aspect of this guidance is that FDA is including social media in its discussions. This is a significant departure from just a few years ago. In 2009, FDA issued guidance on presenting risk information about medical products and completely ignored social media and touched only lightly on the Internet. In 20-plus pages, there were literally three mentions of websites. Just having the FDA acknowledge that the Internet is now one of the most commonplace means of accessing information about health is tremendous progress.
There still are lots of issues that could benefit from FDA guidance. One of the biggest issues is how to supply appropriate risk information in the limited space provided in some social media. Prescription drug promotion is required to include risk information, but you're not always required to provide the same amount of risk information. What would FDA consider sufficient in the 140-character limit of a Twitter message? I don't know, and the FDA has yet to provide any indication."
Liz Cermak, Chief Commercial Officer, Pozen Pharmaceuticals:"I am encouraged that the FDA published new guidance on the use of social media. While these are not the full social media guidelines the industry has been anticipating, they serve as a step forward for the FDA.
What I find most interesting about the guidelines is that while a defining feature of social media is enabling ongoing communication and engagement, the FDA's guidelines ask that pharmaceutical companies take certain conversations 'off-line' and have the company's response not take place via public channel. While taking these conversations 'off-line' reduces concern that these public conversations might be misconstrued as off-label product promotion, in the present state of social and digital media, every conversation—whether intended to be on the public record or not—can easily become public or viral. We live in a world where everything is content.
Unfortunately, the speed of innovation is always going to outpace the FDA's release of such guidelines."