Last week, the Washington Post reported that the FDA had issued a warning letter to a pharmaceutical company concerning statements about a new prescription drug that were made recently by reality television star Kim Kardashian.
On Instagram and Twitter, Kardashian touted the effectiveness of a prescription drug called Diclegis for pregnancy-associated morning sickness. Kardashian has a substantial following on social media — including nearly 35 million on Twitter and nearly 45 million on Instagram.
In addition, Kardashian is a paid spokesperson for the drug’s manufacturer, Duchesnay USA.
The FDA issued a letter to Duchesnay stating, “The Office of Prescription Drug Promotion … has reviewed the Kim Kardashian Social Media Post. 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 also points out that Kardashian’s social media posts fail to report information on potential risks and side effects.
In addition, the FDA expressed concern over the fact that the posts do not mention that Diclegis 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.
While the use of social media in medicine has become 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 among biotech, pharmaceutical, and medical device companies found that there were more than 211 industry-related Twitter feeds, more than115 Facebook pages, and numerous YouTube channels actively communicating with doctors and patients. In fact, one company posted nearly 115,000 Tweets in one year.
While the FDA vigorously regulates 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, but technical difficulties precluded access for many potential attendees.
Ultimately, the FDA issued a draft document to the industry, providing guidance for marketing on Twitter and other social media outlets. The draft document outlined four requirements for a marketing-based social media post.
1. 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.
2. 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.
3. Both the chemical and brand names should be utilized in any social media post.
4. The risk information must be just as prominent as the benefit information contained within the post
From 2008 to 2012, data from the Office of Drug Promotion reflects that the FDA issued more violations for traditional media than for media in the digital space. In fact, official warning letters were three times more likely to be issued for traditional media violations than for digital media postings.
However, it now appears that with the Kardashian warning letter, the FDA is 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. The FDA is now vigorously evaluating medically related applications for mobile devices.
Regulated applications — those 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.
Recently, social media has also 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 percent of the time spent by research staff on a particular trial.
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.
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 about what we read and see on social media, and must always consider the source — just as we view traditional print and television media with a hint of skepticism.
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