In case you missed it, on June 17, the Food and Drug Administration (FDA) released two more in a series of draft guidances related to social media. These separate documents addressed two questions from the 2009 hearings related to (a) the industry’s responsibility for correcting misinformation as well as (b) its ability to communicate within platforms that limit the number of characters, such as Twitter and paid search advertising.
An underlying theme throughout both documents is that pharma now has choices—with limitations, of course. In the first guidance, the FDA makes it clear that, while companies have a choice whether or not to correct misinformation, once they decide to do so, their approach must be balanced. In the second guidance, the FDA also makes it clear that companies have a choice—in this case, whether or not to use character-limited platforms. And if they choose to do so in a promotional manner, they must meet rigorous requirements.
With these and the draft guidance released earlier this year, a discernible framework begins to emerge for regulated companies who choose to participate in social media.
Correcting Third-Party Misinformation:
If You Choose to Intervene, Take the Bad with the Good
We all know that a wealth of inaccurate prescription product information lives on the Internet, and until now, regulated companies’ hands were largely tied to do anything about it. The FDA’s draft guidance on correcting misinformation lays out a fairly clear, common-sense roadmap for companies wishing to correct misinformation posted by third parties. Indeed, the agency acknowledges that user-generated content is not always accurate and in some cases may be harmful to the public health.
During the FDA’s 2009 public hearing when the original question was posed, “What parameters should apply to the posting of corrective information on websites controlled by third parties?” a fair amount of concern was expressed by manufacturers around the implication that FDA expected drug companies to police the entire Internet. This guidance makes clear, however, that this is not the expectation.
Surprisingly, FDA puts forth an uncharacteristically progressive plan for handling misinformation. For example, FDA states that, as long as the firm corrects misinformation in a “truthful and non-misleading” manner and is within labeling, FDA will not require pharma companies to include fair balance embedded within the correction. Pharma companies must be careful, however, to not “selectively correct” information. For example, they should not correct information that portrays their product negatively without also addressing overstated claims appearing in the same area of that forum.
The FDA also reiterates that regulated companies are not responsible for third-party user generated content about their products if truly independent and not influenced by the company. This is an important point especially because the FDA states this applies even on properties that the company owns, operates and moderates. This further clarification should help companies feel more comfortable with hosting social platforms—such as Facebook pages and online patient communities—that invite and incite two-way dialogue. In the past it was the fear of the unknown, the inability to predict and—most of all—the lack of control over open forums that kept pharma companies from creating more open dialogues. Now, the FDA has made clear that as long as the proper disclaimers are in place and that the content is truly independent, regulated companies are not on the hook for user comments.
As with all things FDA guidance-related, the devil is in the details and an infinite number of different scenarios exist. Can pharma behave within the remaining gray area? Let’s hope so. Indeed, patient safety may be counting on it.
Social Media Platforms with Space Limitations:
If There’s No Room, There’s No Way
If you don’t have the time to review the 15 pages it takes for FDA to explain its requirements for using Twitter and Google AdWords, the gist of the agency’s stance can be summed up in this one sentence:
“If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.”
FDA lays out, piece by piece, the requirements for communicating promotional information in character-limited platforms. In summary, a tweet or paid search ad would need to contain the following:
- Brand name
- Generic name
- Any material facts
- Comparable or most serious risk information
- A link to more risk information.
The only point on which FDA seemed to provide any leeway was the omission of dosing information. Still, that’s a whole lot of information to fit into a tweet or search ad, and it’s tempting to think the joke is on us—the FDA has set up an impossible scenario. But to my surprise and somewhat delight, FDA did prove it can be done. Through use of a fictitious drug, FDA provided examples to demonstrate that compliant use of character-limited platforms, while indeed difficult, is not impossible. The FDA even broke it down into three examples to show how you can arrive at a message containing less than 140 characters while including all the necessary information. Their final 134-character tweet for the fictitious NoFocus, which is indicated for mild to moderate memory loss, was:
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk
Until now, FDA’s prior guidance and letters followed the regulatory ideology of “it’s the message, not the medium” that poses the problem. But this time, there’s a twist. In the case of character-limited platforms, if the medium doesn’t work for FDA’s requirements around your message, you shouldn’t use it. So now we know: Limited characters mean limited options. Only certain brands with certain profiles will be able to effectively apply the magic formula.
Options and Opportunities
It’s been five years since the 2009 hearing that promised social media guidance. Many companies chose not to wait and have been moving forward—cautiously—with a variety of social media programs. Meantime, the FDA has issued warnings for communications taking place on social platforms such as Facebook, YouTube and sharing widgets. But again in each case it was the message—not the medium—with which the FDA took issue.
Yes, there are restrictions. But now there is also clarity. And only fools would have expected carte blanche permission from FDA. Though these are draft guidances and FDA is accepting comments and questions, it is expected that pharma companies will begin following these guidances as if the letter of the law.
A framework has begun to emerge—one in which pharmaceutical and similarly regulated industries can actively, more flexibly and compliantly participate in social media. The FDA is lifting its longstanding silence and not only providing social media guidance, but presenting a framework that affords choices.