The U.S. Food and Drug Administration (“FDA”) has issued numerous Warning and Untitled Letters[1] delving into very specific aspects of social media (such as “likes” on Facebook, tweets on Twitter and posts on Tumblr, collectively, the “Social Media Letters”). Recently, the FDA warned a drug manufacturer and its agent that even the “About Us” or “Company Information” section of a Facebook page must be comprehensive and must include the drug’s material facts and associated risks in order to avoid FDA charges of misbranding.
In the February 24th letter, the FDA alleged that the drug manufacturer and its agent misbranded the drug Tirosint (levothyroxine sodium) by omitting “material facts” and risk information from the drug’s Facebook page. The page, which from the screenshot supplied by the FDA, contains no posts, promotional media or links to information regarding the drug. Instead, there is a small box for a company profile which states the following:
“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.”
In the letter, the FDA noted that Tirosint is approved as a replacement or supplemental therapy for many types of hypothyroidism, but it is not approved for use on transient hypothyroidism during the recovery phase of subacute thyroiditis. The FDA considered the Facebook statement to be omitting material facts about the drug. Further, the FDA noted that Tirosint “is associated with a number of serious risks” – none of which were disclosed on the Facebook page. The FDA wrote that “by omitting the most serious and frequently occurring risks associated with Tirosint, the Facebook webpage misleadingly suggests that Tirosint is safer than has been demonstrated.”
The significance of this letter is that, while previous Social Media Letters sought to regulate Facebook actions (e.g., the use of “likes”) and content (e.g., posts on Facebook, tweets on Twitter or images on Tumblr), drug manufacturers and their agents should exercise care when creating social media accounts. Here, the FDA issued a letter not because of the Facebook actions or for content propagated to promote the drug, but because the “Company Information” box was incompletely annotated at the formation of the Facebook page. The underlying message from the FDA is a return to the basics – to avoid charges of misbranding, consider all representations made to the general public regardless of the context or location.
This article was prepared by Jay Greathouse
(jay.greathouse@nortonrosefulbright.com / +1 210 270 7155), an associate in Norton Rose Fulbright’s corporate practice group.
[1] A Warning Letter is FDA Correspondence that notifies a regulated industry about violations of the Federal Food, Drug and Cosmetic Act that the FDA has documented during its inspections or investigations. According to the FDA’s Regulatory Procedures Manual – July 2012: “Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected.” Untitled Letters are initial correspondence with members of a regulated industry that do not meet the threshold of a warning letter and are reserved for situations where the FDA may not be prepared to take enforcement action.
