Medical device companies and big pharma need to be more proactive in terms of utilizing social media. That’s according to one expert who spoke at a recent FDAnews webinar.
Peter Pitts, a former FDA official and an executive partner at YourEncore, says that over the years, both industries have displayed reluctance in adopting social media. They point to reprimands, including an April 2009 warning letter to 14 pharmaceutical companies over sponsored links seen in Internet searches and a 2008 caution on a YouTube promotion. He says that there was a “secret sigh of relief” by members of industry who thought they could avoid social media as a result of the FDA’s actions.
Not so fast, says Pitts. He tells IDDM that many companies think tending to social media sites is just too hard. They believe it requires an additional full-time employee, and there are many legal and regulatory implications that can affect what they post. “Social media is 24-7,” he says, and that intimidates companies.
But whether it’s a tweet or a Facebook posting, pharmaceutical and medical device industries need to get with the times. And it’s pretty simple, says Pitts — companies need to make sure that they tell the truth. “Truthful, accurate and transparent—those are three good rules of thumb,” Pitts adds.
In terms of third-party posts, Pitts cautions companies against liking a statement that exaggerates the effectiveness of a device. “Liking a violative statement on your platform is violative behavior,” he explains.
For incorrect statements on third-party sites, sometimes it’s in the best interest of public health to clear up a wrong assumption or misinformation — especially if a post overstates a product’s effectiveness. In 2014, the FDA issued draft guidance on this topic, in which it says companies generally aren’t responsible for third-party communications posted on outside websites or platforms. It says that firms may voluntarily correct misinformation — an action Pitts backs.
He adds that companies don’t have to be vigilant all of the time, even when it comes to previously corrected pages. If companies act appropriately and work on addressing the misinformation, they will not be held responsible in the future.
That said, it’s in a company’s best interest to keep records on any corrective actions it has undertaken.
The FDA’s attention to social media posts is unique, Pitts tells IDDM, adding that the situation in other countries isn’t the same.
The FDA has released guidance documents intended to help industry. For example, in 2011, it unveiled draft guidance on addressing unsolicited requests for off-label information related to both drugs and medical devices. It came in the wake of a citizen petition filed by seven drugmakers seeking clarification on the topic. That document has yet to be finalized.
It also has released guidance on fulfilling requirements for postmarketing submissions of interactive promotional media. Pitts says FDA draft guidance issued last year on Internet or social media platforms with character space limitations has brought a lot of comments. For example, the 510(k) Coalition urged the FDA to develop a strategy for space-restrictive platforms for medtech that is distinct from pharmaceuticals.
“[T]he majority of medical devices are used as ‘tools’ to assist healthcare professionals and patients in treating or diagnosing disease but do not, themselves, provide therapy,” the group says in its comments. “These products do not fit into the ‘drug model’ that forms the basis for the draft guidance.”
The comments also question the assumption that users will make clinical decisions based on a tweet or a banner ad.
In separate comments, industry trade group AdvaMed agreed that devicemakers need to provide appropriate risk information within social media platforms. That said, “care must be taken with a one-size-fits-all approach,” the group adds.
“We are concerned that device firms will also be in a position of subjectively picking and choosing a specific relevant risk at the expense of others rather than linking more appropriately to a page with fuller information,” according to the comments. It suggested that the FDA consider a fair balance of a combination of links with appropriate introductory language, particularly since consumers are used to clicking on links to obtain additional information. — Elizabeth Hollis