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Publications: Ask an Expert about Off-Label Promotion By Sara Dyson, Esq.

Question:  What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device?

 

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Sara Dyson, Esq.

Answer: Promoting medical devices and drugs for uses that have not been approved by the Food and Drug Administration (FDA) constitutes off-label promotion, which is forbidden by the Federal Food, Drug and Cosmetic Act (FDCA).  Companies that promote off-label face severe criminal and civil penalties.  In recent years, off-label promotion has been the subject of countless Warning Letters, cost the industry billions in fines, led to jail time for company executives, resulted in Corporate Integrity Agreements and Deferred Prosecution Agreements, and triggered costly products liability lawsuits.  Yet, even so, many medical device and drug companies continue to profit significantly from the off-label uses of their products.

Read more here…

 

 

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WEBINAR: The AdvaMed Code of Ethics: What it Means for the Industry & Your Company

Wednesday, May 22, 2013 at 2:00 PM EDT

Webinar Guest Speaker

Andrew Van Haute, Esq. is Associate General Counsel of Advanced Medical Technology Association (AdvaMed).

Interactions between health care professionals and medical technology companies fuel the advancement of new technology and improve the quality of medical care through training and education. However, it is important that these relationships never cross the line to impropriety, particularly in today’s age of the Sunshine Act and state and federal anti-kickback regulations. Even the appearance of misconduct in this respect can have serious regulatory, products liability, and even criminal consequences for life sciences companies. The AdvaMed Code of Ethics provides guidance and a set of standards for companies to follow in order to ensure that their interactions with healthcare professionals are appropriate, and thus that the healthcare professionals’ selection of particular products are only reflections of their independent medical judgments and cannot be attributed to the influence of company personnel.

This webinar will address:

  • What the AdvaMed Code of Ethics is and what it covers
  • The impact the Code has had on life sciences companies
  • How its implementation can help your company

Register and learn more here