One in three American adults have gone online to figure out a medical condition. Consequently, social media is increasingly being adopted as a tool for promoting medical devices (e.g., Facebook, Twitter, Pinterest, etc.).
Patients are starting internet support groups, rating devices on Yelp! and sharing photos on Reddit and YouTube. In contrast, medical professionals are using internet communities like Sermo.
Use of these social media platforms has become an area of particular interest by regulators in the past few years based on FDA’s multiple guidance documents.
FDA is authorized by the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) to regulate the labeling of all medical devices and the advertising only of “restricted devices.” FDA designates restrictive devices by either (a) embedding such designations in orders granting premarket application (PMA) approval to Class III devices or (b) issuing regulations designating particular device types as restricted, which is the case for hearing aids and analyte specific reagents (ASRs). Therefore, the overwhelming majority of Class I and Class II devices, as well as the remaining Class III devices not designated in PMA, are not restricted.
In January 2014, FDA released draft guidance addressing the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media to promote human or animal drugs. Then, in June 2014, FDA issued two draft guidances focused on social media platforms. The June guidance explains FDA’s current thinking on how manufacturers, packers, and distributors of prescription human and animal drugs and medical devices for human use, including biological products, that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling of their FDA-regulated medical products on electronic/digital platforms that are associated with character space limitations, specifically on the Internet and through social media or other technological venues. The guidances focus on the communication of risks and benefit with of character space limitations on social media platforms (like Twitter) and efforts by firms to correct third party misinformation on these platforms.
The Character Space Guidance gives little room for social media wiggle room. The guidance states that “[r]egardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.” This may be easier said than done since the limit for a tweet is 140 characters. In addition, firms should also provide a mechanism, most likely a link, a “more complete discussion of the risks associated with its product.” This portion of the guidance is well within the constructs of social media advertising.
In the Misinformation Guidance, does a better job at understanding the woes of the social media comment section. FDA states that companies do not have obligations to correct misinformation created by third parties. One complication to this rule is when a company voluntarily corrects. In this situation, a company is not required to adhere to all FDA guidelines. Specifically, they do not need to include any safety or risk information.
The increased complication of advertising medical devices on social media has lead to reticence from consultants to encourage their clients to us platforms such as Facebook and Twitter. Cassie Benowitz, account supervisor at Minneapolis-based StoneArch Creative gives insight as to why social media may not be the best place for medical device companies to advertise. First, “customers of medical device companies — typically physicians and hospital administrators — don’t use Facebook or Twitter to gather information about a product.” She explains, “[t]he thing about Facebook is that that’s not necessarily where a physician audience is going to go to look for clinical information or even an administrator audience.”
Second, using Facebook or Twitter can be extremely time-consuming for a company. To do it well, you need to be very active and unless there is someone there whose main responsibility is to monitor and respond to comments, the risk may not be worth the reward.
While social media is on the rise and medical device companies may see Facebook and Twitter as new frontiers of advertising, they should be wary of using these to advertise their products. Until the FDA releases official regulations, tweeting and posting about medical devices should be done with a strict adherence to the current guidelines.