On March 12, FDA’s Office of Prescription Drug Promotion (OPDP) posted an untitled letter on its webpage alleging that Institut Biochimique SA’s (IBSA) Facebook page for the drug Tirosint® misbranded the drug. Though the enforcement letter discusses a drug, the principles discussed in the letter are instructive for medical device promotion activities. The untitled letter is particularly noteworthy for its focus on one statement on a firm’s Facebook page.
The untitled letter cites the following statement on the Facebook page regarding Tirosint:
If you have just been diagnosed with hypothyroidism or are having difficulty controlling your levothyroxine blood levels, talk to your doctor about prescription Tirosint, a unique liquid gel cap form of levothyroxine.
According to OPDP, the statement above was a promotional claim about efficacy, and the company should have included risk information regarding the use of Tirosint on its Facebook page, particularly because Tirosint contains a “Boxed Warning” (a warning that FDA considers particularly serious). In addition, OPDP stated the company failed to include material information regarding a limitation on the use of Tirosint (i.e., that it was not indicated for hypothyroidism during the recovery phase of subacute thyroiditis).
FDA has previously included claims made on Facebook or other social media platforms along with broader allegations of misbranding using a variety of sources in its enforcement letters. For example, in December 2012, FDA issued a warning letter to AMARC Enterprises, Inc. for “liking” a third-party poster’s comment, which FDA alleged misbranded the drug. The reference to the statement on Facebook was one of many other statements cited by FDA, including statements on AMARC’s website. In addition, in July 2010, FDA issued an untitled letter to Novartis Pharmaceuticals Corporation relating to the “Facebook Share” widget on its Tasigna® product website. According to FDA, the widget generated many promotional claims about Tasigna that popped up on the Tasigna website (which a user could then post to Facebook with a few clicks) and misbranded the drug by failing to include any risk information with the claims, among other reasons. Similarly, in other recent letters citing statements on a Facebook page (e.g., here, here, here, and here), FDA also discussed a number of other sources and statements allegedly indicating that products were misbranded or adulterated. By contrast, the present untitled letter focuses solely on a single statement on a Facebook page and does not take issue with any statements outside the Facebook page.
The untitled letter was issued to IBSA with a copy to its U.S. agent, Akrimax Pharmaceuticals, on February 24, 2014. This was roughly a month after the Center for Drug Evaluation and Research (CDER) issued a draft guidance on social media (analyzed here), which provides recommendations on whether and how drug manufacturers should submit certain promotional material on social media to FDA at the time of first use, which is required under FDA’s drug regulations. Interestingly, OPDP’s letter does not indicate whether IBSA submitted the Facebook page to FDA at the time of first use, nor allege that the company violated regulations by failing to do so. In addition, OPDP’s letter did not indicate that the Facebook page should be taken down. However, the Facebook page appears to have been disabled as of March 13, 2014.