Weary of FDA foot-dragging on digital and social media guidance for pharmas, a group of 60-some industry digerati
have put together guidelines of their own.
The Digital Health Coalition
(DHC) said its seven “Guiding Principles and Best Practices for Companies and Users”
represents a consensus of the industry's top digital marketers. Questions of control over content—and when pharmas are responsible for correcting misinformation they find online—were the thorniest, said founder Mark Bard, and will be explored further by a working group.
“The definition of control has a fundamental impact on everything,” said Bard. “Everything cascades off that question of when control begins and ends.”
For now, the DHC presented the issue in principle No. 2: “Regulated healthcare companies are not responsible for user-generated content online that they do not control. Regulated healthcare companies are deemed to 'control' health and medical content if (i) it owns such health and medical content and has material editorial authority or (ii) it paid for the creation of such content and has material editorial authority over such content."
On the related issue of companies' obligations to correct misinformation, the DHC's principles say: “Regulated healthcare companies should endeavor to make reasonable efforts to correct misinformation that is factually incorrect.”
Though the document was conceived as an exercise in industry self-regulation, the group hopes it will inform FDA thinking on the topic.
“We know from conversations that it's very helpful to regulators to communicate what consensus thinking around topics is today,” says Bard, though noting that the DHC's best practices represent not official company policies but rather a sounding of top execs tasked with digital marketing and communications at pharmas.
The seven principles, said DHC's Joe Farris, “are a starting point. We don't view them as the holy grail of guidance. They're not the final document but a starting point from which to move the industry and the conversation further. We look forward to debating them and they're open to comment.”
The principles and best practices are as follows:
1) Regulated healthcare companies should endeavor to participate in social media as a means to promote public health, improve patient outcomes and facilitate productive patient/physician relationships.
2) Regulated healthcare companies are not responsible for user-generated content online that they do not control. Regulated healthcare companies are deemed to “control” health and medical content if (i) it owns such health and medical content and has material editorial authority or (ii) it paid for the creation of such content and has material editorial authority over such content.
3) Regulated healthcare companies have a responsibility to report adverse events they become aware of. Regulated healthcare companies should follow the existing adverse event reporting rules in place at the FDA.
4) Employees of regulated healthcare companies should disclose their material company relationship when posting comments/content or engaging in an online conversation relating to a company product or relevant healthcare issue.
5) Regulated healthcare companies should endeavor to respond to questions on sites they control within a reasonable period of time, and to implement reasonable measures to enable timely responses to crisis and emergency situations.
6) Regulated healthcare companies should endeavor to make reasonable efforts to correct misinformation that is factually incorrect.
7) Regulated healthcare companies should endeavor to appoint employee(s) tasked with the role of “patient liaison” focused on representing the best interests of the patient online.