This week, the Washington Post reports that the FDA has issued a warning letter to a pharmaceutical company concerning statements about a new prescription drug that were made by Kim Kardashian on her recent posts on social media. In her posts on Instagram and twitter, Kardashian touts the effectiveness of a prescription drug called Diclegis for pregnancy associated morning sickness. Ms Kardashian has a substantial following on social media—including nearly 35 million on Twitter and nearly 45 million on Instagram. Of note, Kardashian is a paid spokesperson for the drug maker Duchesnay USA.
The FDA issued a letter to Duchesnay USA “The Office of Prescription Drug Promotion … has reviewed the Kim Kardashian Social Media Post,” the letter states “The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information.” In the letter the FDA points out that the social media posts fail to report information on potential risks and side effects. In addition, the FDA expressed concern over the fact that the social media posts do not mention that the drug has not been studied for women with certain pregnancy complications and that the drug is not suitable for women who are sensitive to several other types of medications.
Social media, when used properly, can be a powerful tool for patient engagement and patient education. It can also be a very effective marketing tool and can be utilized in the recruitment of patients for clinical trials. While the use of social media in medicine becomes more popular and more widespread, the FDA has been very slow to respond with a position statement. In 2012 a survey of social media use amongst biotech, pharmaceutical and device companies found that there were more than 211 industry related twitter feeds, over 115 Facebook pages and numerous YouTube channels actively communicating with doctors and patients. In fact, one company had nearly 115K tweets in one year. While the FDA vigorously regulates medical traditional communications regarding medical treatments, there has been a significant lack of regulatory guidance for the internet and social media use. In July 2014, the FDA attempted to produce a webinar to discuss the use of social media by industry and physicians—however, technical difficulties precluded access for many potential attendees. Ultimately, the FDA did issue a draft document to industry providing guidance for marketing on Twitter and other social media outlets.
What Did the FDA Draft Document Advise?
For the most part the draft document outlined requirements for a marketing based social media post.
- Each post must discuss both the benefits and risks of the drug or device—the information must be balanced. The benefit information must be accurate and not misleading in any way.
- Ideally, a hyperlink should be included in any twitter or social media post. This hyperlink should provide detailed information on risk and adverse effects of the marketed product.
- Both the chemical and brand names should be utilized in any social media post
- The Risk information must be just as prominent as the Benefit information contained within the post
What Exactly is the FDA doing in Social Media/Cyberspace regulation?
(Data obtained from White Paper “Eye on the FDA” by Mark S Senak, JD)
During the time period from 2008-2012, data from the Office of Drug Promotion reflects the fact that the FDA issued more violations for traditional media than those issued for media in the digital space. In fact, official warning letters were three times more likely to be issued to traditional media violations as compared to digital media postings. However, now it appears that with the Kardashian warning letter that the FDA is now poised to more closely scrutinize social media marketing efforts.
Advertising and marketing in the social media space is not the only new area of FDA regulatory interest in cyberspace. Now, the FDA is vigorously evaluating medically related applications for mobile devices. Regulated applications—those that the FDA considers to transform a mobile device into a medical device—are any applications that utilize sensors or attachments or any devices that provide patient specific analysis.
What About Clinical Trials?
Recently, social media has emerged as a very effective tool for the recruitment of patients for clinical trials. In most studies, the biggest barrier to a successful project is the effective recruitment of appropriate patients. In fact, patient recruitment typically accounts for nearly 30% of the time spent on a particular trial by research staff. The FDA now requires that social media ads, tweets, blogs and other forms of digital communication be reviewed in the same way that traditional recruitment materials are reviewed.
For Now, the FDA will continue to “Keep up with the Kardashians”
This week’s action by the FDA makes it clear that more regulation of medical related activity in cyberspace is on the horizon. As consumers we must be careful of what we read and see on social media and must always consider the source—just as we often view traditional print and television media with a hint of skepticism.
(photo courtesy of E!)