Vanda Pharmaceuticals Responds To Recent FDA Guidance

Communication of novel scientific findings and emerging therapies is crucial to inform healthcare providers about new treatment options that did not exist at the time of their medical training. Innovators who conduct this research play a significant role in communicating this new information to healthcare providers. The FDA’s guidance document, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products (October 2023), threatens drugmakers with criminal misbranding liability when they share truthful, non-misleading scientific information about unapproved uses of FDA-approved drugs—like the results of a new clinical trial—with healthcare providers unless the communication satisfies vague and nebulous FDA standards for both form and scientific substance. The FDA’s assertion of such broad authority to censure the scientific information that drug manufacturers may share with healthcare providers—doctors and others who are working tirelessly to find innovative solutions for individual patients suffering from a wide range of afflictions—is of grave concern, as it encroaches on freedom of speech, hastily attempts to coerce manufacturers into compliance without due process, and imposes rules without clear direction from Congress in addressing major questions that broadly affect the practice of medicine and public health.