The Food and Drug Administration (FDA) announced that it will hold a public hearing on November 9 and 10, 2016, for input from stakeholders to inform FDA’s policy development in the area of manufacturer communications for unapproved (off-label) uses of approved or cleared medical products. Since the recent court cases regarding off-label pharmaceutical advertising, FDA is performing a comprehensive review of its regulatory framework related to manufacturer communications of off-label uses for approved or cleared medical products. In this review, FDA seeks to find a new balance between communications about the known, safe and off-label uses for medical products and protecting the public health. FDA seeks both verbal and written comments during and after this hearing.
Stakeholders that wish to comment may attend the hearing to submit verbal comments, or may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
For more details, please download the complete Client Alert we have prepared.