Social Media Communications Are Compliance Challenge For Drug and Device Companies

The FDA has for years been sending out warning letters to pharmaceutical and medical device manufacturers regarding drug, biologic, and medical device product communications on social media, but the agency has not yet formulated a guidance. The question is to what extent certain communications need to incorporate warnings and limits on use. A guidance is due out in July, but in the meantime Epstein Becker Green attorneys Natasha F. Thoren and Benjamin M. Zegarelli recommend paying close attention to a draft guidance that was issued in January of this year. It sheds some light on what kinds of social media companies are and are not responsible for, although it also leaves much unanswered. One example noted by the authors: It doesn’t clarify whether “liking” on Facebook or re-tweeting someone’s post gives a manufacturer “control or influence” over a third-party site. The authors provide a list of questions that manufacturers should address when formulating their interim compliance practices.