Florham Park counsel Jodi Rosenzweig recently published an article in New Jersey Defense Magazine’s 2017 spring newsletter titled, “Off-Label Promotion of Drugs and Medical Devices: is the FDA Listening?”
In November 2016, the Food and Drug Administration (FDA) held hearings on its regulations governing manufacturer communications about unapproved uses of FDA-approved medical products. While physicians can legally prescribe drugs and medical devices for unapproved, or “off-label,” use, the FDA refers manufacturers for criminal prosecution if they promote off label uses.
With FDA restrictions on truthful and non-misleading promotion of off-label use being the subject of First Amendment challenges, the FDA gave an analysis and requested feedback through a memorandum on the impact of off-label communications on public health and various policy issues.
In the article Jodi reviews these off-label uses and promotion, and offers a summary of First Amendment case law with commentary on the analysis in the FDA Memorandum.
Read: “Off-Label Promotion of Drugs and Medical Devices: is the FDA Listening?” on page 14 of the newsletter.