Greene & Kesselheim vs. Kardashian
Jeremy Greene and Aaron Kesselheim have a fascinating piece on the new challenges facing the FDA as selfie-driven marketing reaches Instagram. After promoting an anti-nausea drug (for morning sickness, not in anticipation of celebrity-phobic viewers), Kardashian had to follow up with the following “corrective advertisement:”
#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis.
As Greene and Kesselheim observe:
The rise of social media has raised a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role. Before Instagram, television advertising was once new; before television, radio. Since the agency’s founding, its ability to regulate drugs has been consistently challenged by new forms of communication.
For more on the controversy, check out The Week in Health Law, where Nicolas Terry and I discuss the case with Kesselheim. And don’t worry, it’s not all about Kardashians–we also cover a new study of ACOs, proposed budget cuts for AHRQ, worry over unintended consequences of readmission penalties, and EHR gag clauses (and developer codes of conduct).