The citations underscore big challenges pharma must endure when using social media without breaking federal rules.
The Food and Drug Administration on July 29 sent a letter to Novartis to issue four violations in concerns regarding its use of Facebook's "Share" button. The pharmaceutical company drew the ire of the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) because its webpage for the leukemia drug, Tasigna, employed the button without following the administration's ad copy guidelines.
The violation that was perhaps most relevant to social media cited by the FDA: When viewers clicked a page's Share button, the copy that appeared in the Facebook newsfeed only stated benefits, but not risks of the drug. The federal agency generally requires that any copy promoting a drug or treatment's benefits must also include the ability to see or hear information about the potential risks.
Secondly, the copy seen via the Share function didn't properly discern what portion of the leukemia population for which Tasigna could be appropriate. The third citation involved the usage of the copy "next‐generation treatment." The FDA said the language implied superiority over competing products when such a statement couldn't be backed by objective research findings.
These first three citations truly underscore the challenges that pharma marketers have with the normally terse nature of social media communications. In short, keeping in line with the FDA's provisions probably would have required paragraphs of copy - which isn't exactly conducive to the Share button functionality - or Facebook in general.
Pharma marketers often complain that the FDA has not provided clear guidance on drug marketing within social media channels. Yet, in this case, Eileen O'Brien, director of search and innovation for pharma marketing agency Siren Interactive, said the violations had more to do with failing to adhere to well-established FDA/DDMAC guidelines than they did with the unusually complex nature of pharma social marketing.
"This letter does not provide guidance on Facebook, but calls out Novartis for content that does not provide fair balance among other things," O'Brien said in an e-mail to ClickZ. "It's the message, not the medium. Following current FDA guidance, pharma marketers should ensure that ‘Share This’ text is either ‘help-seeking’ [referencing the indication, but not containing the product name] or, if it's not a Black Box product [meaning the drug package must carry a warning about adverse effects], a reminder ad [containing the name but making no product representation]."
The Switzerland-based pharma company e-mailed the following statement to ClickZ: "Novartis takes the letter issued by the FDA very seriously and we have addressed its concerns by taking the direct and immediate action of taking down the widget referenced by the FDA. Novartis will continue to have active discussions with the FDA to understand fully all of the concerns. We also will assess all of our Web assets and materials based on these concerns.”
Lastly, the FDA's letter states that Novartis didn't submit the content it allowed to be shared via Facebook 30 days prior to submission - which is a standard regulation for online and offline communications. Also, the agency suggested this part of its ruling represented guidance for all social media outlets in terms of content created by a pharma company. To be clear, the agency didn't extend the judgment to include language making companies responsible for user-generated content.
Meanwhile, the FDA's often cloudy regulations are just one of the reasons why pharma marketers are intimidated by social media. Others include lack of control over brand messages and the threat of class-action lawsuits brought as a result of consumers using social tools to report adverse drug effects.
Follow Christopher Heine on Twitter at @ChrisClickZ.
Christopher Heine was a senior writer for ClickZ through June 2012. He covered social media, sports/entertainment marketing, retail, and more. Heine's work has also appeared via Mashable, Brandweek, DM News, MarketingSherpa, and other tech- and ad-centric publications. USA Today, Bloomberg Radio, and The Los Angeles Times have cited him as an expert journalist.
US Consumer Device Preference Report
Traditionally desktops have shown to convert better than mobile devices however, 2015 might be a tipping point for mobile conversions! Download this report to find why mobile users are more important then ever.
E-Commerce Customer Lifecycle
Have you ever wondered what factors influence online spending or why shoppers abandon their cart? This data-rich infogram offers actionable insight into creating a more seamless online shopping experience across the multiple devices consumers are using.
September 9, 2015
12pm ET/9am PT
September 16, 2015
12pm ET/9am PT
September 23, 2015
12pm ET/ 9am PT