July 21, 2014 – Although the FDA has attempted to provide some clarity on its position regarding certain social media issues and practices, the agency’s recent draft guidance documents do not leave industry communicators with a crystal clear path and, indeed, “raise some important questions that communicators may have for their counsel,” according to Mark Senak, senior vice president and partner, FleishmanHillard, Washington, D.C., and author of the blog Eye on FDA.
Senak, who spoke at a July 17 FleishmanHillard Webinar, “In More Than 140 Characters … FDA’s Social Media Guidance: Past, Present and Future,” said that the Internet and social media “have emerged as an extremely important, vital source of information for patients and caregivers,” and that these platforms have “transformed journalism from an act of listening to messages to participatory engagement.” Social media is no longer a “patch” but “part of the fabric of communication,” he remarked.
During the Webinar, Senak highlighted the five basic social media issues, listed below, for which companies are seeking answers from the agency.
What are firms responsible for? Senak noted that the FDA’s January 2014 guidance on fulfilling postmarketing requirements does discuss this issue, but certain provisions that say companies have or do not have responsibility for content they either do or do not influence or control are somewhat confusing. “There are some wedges there,” Senak said. “What is influence? If a company advertises on a site? If it’s the sole advertiser? It’s not clearly spelled out.” He also pointed out that some of the language used by the agency, such as the use of the word “generally” before “not responsible” adds to the level of industry uncertainty.
How do firms use character- or space-limited platforms and remain in compliance? The FDA’s June 2014 draft guidance sets out when and how such platforms may be used and provides hypothetical examples for “NoFocus” and “Headhurtz” fictional products. Senak posed the question that given all of the required elements in such a limited space – benefit, chemical name, most important risk information and link with product name and the word risk – “whether or not the Tweet, in this form, is in fact, useful” from a marketing perspective?
How do firms correct misinformation online? The FDA “lays out a pathway for correcting misinformation online so firms can correct” that data, Senak explained. The practical considerations for firms to note, in addition to what is stated in the guidance, are that firms should realize that if they “go beyond the correction of misinformation the communications have to comply with all the applicable regulatory requirements about labeling and advertising, … that companies that choose to correct do run a risk if the correction is executed incorrectly, so some companies may opt out,” and that companies that do choose to correct are going to have to consider “the development of really well-drawn, controlled policies and procedures and protocols for [handling] the correction information and recordkeeping.”
When is it appropriate to use links? The FDA’s position on links was addressed in the discussion of the character- and space-limited messages and in 14 Warning Letters issued by the FDA which cited companies for incorporating risk information solely by the link. “The FDA has made clear that that is not acceptable,” Senak said. Later in the presentation he advised a Webinar attendee that the FDA stated in the space-limited media guidance that although link shorteners may be useful tools, the agency prefers that the link include the word risk and would like any customized links to have the word risk in it.
How do the rules/policies apply to adverse event reporting? “There is no guidance yet on this issue,” Senak said, adding that in the FDA’s draft guidance addressing user-generated comment, adverse event information “is unexplored” by the agency.
Senak also brought to attendees’ attention several Warning Letters issued by the FDA – but not by the Office of Prescription Drug Promotion (OPDP) – one that cited one company for “liking” a comment about an off-label, human use for a pet dietary supplement and one that cited a dietary supplement site’s search engine, which brought up product lists for the search terms “cancer” and “diabetes.” These enforcement actions may indicate that when a company endorses or infers that a noncompliant use is appropriate, “then the responsibility flows to the company,” according to Senak.
Bottom line, Senak said that although there are gaps in the five areas described above – particularly for how to handle adverse event information online – the agency’s draft guidances “have very little impact on current pharma practices.” However, “companies may wish to respond with policies that are in accordance with their regulatory culture,” he said.
“A fuller picture will only emerge over time as OPDP issues Warning Letters and further guidance,” Senak concluded.