FDA’s Meeting on Promotion - Can We Glimpse the Future?
In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.
It is no secret that ever since the Coronia case, the United States Food and Drug Administration (“FDA”) has been working on a comprehensive review of the regulatory framework related to firms’ communications about unapproved uses of approved/cleared medical products. These are products that are approved to be marketed for a particular use, but physicians and healthcare professionals have discovered other uses for the product that the FDA has not approved (e.g., unapproved use). The question dogging the FDA is whether a manufacturer may legally discuss the unapproved use with healthcare professionals beyond merely responding to a question if the information being imparted is both truthful and not misleading.