FDA: Is Off-Label on the Table?
DOI:
https://doi.org/10.5912/jcb708Keywords:
Off-Label Communications, Free Speech, Regulated Speech, Caronia, OPDP, Good Reprint GuidanceAbstract
Biopharmaceutical companies have the most complete and up-to-date information about the medicines that they research, develop and manufacture for use by patients. However, companies are often unable to proactively share valuable information about their medicines, especially for information that is not contained in the FDA-approved prescribing information (the package insert you often receive with a prescription), with physicians and other healthcare providers.
The new FDA draft guidance opens the door for companies to share truthful, scientifically accurate, and data-driven information with healthcare professionals to inform treatment decisions.References
See National Cancer Institute, Off-Label Drug Use in Cancer Treatment, available at http://www.cancer.gov/cancertopics/druginfo/offlabeldrug.
Christopher M. Wittich, et; al., Ten Common Questions (and Their Answers) About Off-label Drug Use, Mayo Clinic Proceedings, available at http://www.mayoclinicproceedings.org/article/S0025-6196(12)00683-0/fulltext#sec3.
