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November 18th - Philadelphia Medical Device Seminar Series - Off-Label Use of Medical Devices: Promotion and Compliance


October 19, 2009

Wednesday, November 18, 2009

More more information and to register, click here.

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 Most recently, FDA has put together a draft guidance that could permit companies to use certain types of materials such as peer-reviewed articles to promote products off-label.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