October 19, 2009
Wednesday, November 18, 2009
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Drugs, biologics, and devices are widely used to treat patients in ways that were not specifically approved or cleared by FDA. While FDA does not regulate the practice of medicine or off-label use, it does heavily regulate off-label promotion. Most recently, FDA has put together a draft guidance that could permit companies to use certain types of materials such as peer-reviewed articles to promote products off-label.
In addition to FDA, the U.S. Department of Justice has firmly taken control of off-label use allegations against pharmaceutical, biotechnology, and medical device manufacturers through the Food, Drug and Cosmetic Act (FDCA), the Anti-Kickback Statute, and the False Claims Act.
This tension between patient benefit and government enforcement puts companies in a difficult position. Should they remain silent when data is developed that may benefit patients, or risk prosecution and litigation related to off-label promotion by disseminating scientific information that may indicate important therapeutic options for patients?
In this seminar, the panel will discuss problems arising from off-label use and promotion, while providing practical instruction on how to deal with them.
Topics will include:
- Training and monitoring sales and marketing representatives
- Product liability litigation and other civil actions including Allergan vs. United States of America, et al.
- Government enforcement of off-label sales and marketing compliance