Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement

Held June 27, 2008

Since November 2006, some of the biggest healthcare fraud prosecutors in the country have been speaking publicly about impending medical device investigations — specifically off-label issues.

Those issues include a civil investigation of allegations that Boston Scientific and other suppliers improperly promoted biliary stents for off-label uses, as well as a $2.3 million judgment against NuMED and its president who pled guilty to distributing cardiac stents without premarket approval by the FDA.

With a growing focus on medical device off-label promotion and the Justice Department’s docket of more than 500 ongoing investigations, manufacturers need to understand when they’re about to cross the line of noncompliance — and how to avoid it.

This 90-minute audio CD/transcript led by noted attorneys James Ravitz and Alana Wexler, who will examine the current and future off-label promotion environment. Discover how government prosecutors view the difference between device and pharmaceutical companies — and how that affects their enforcement procedures. Plus, James will detail how to ensure compliance with device-specific strategies based on recent case studies. 

Order now to find out how you can minimize the risk of being investigated for an off-label promotion violation and ensure your promotional program is in compliance:

  • 10 compliance strategies focused specifically on medical device off-label promotion
  • Six dos and three don’ts that will improve communication with medical professionals
  • Three types of off-label communications that may not be considered violative, and actions that your staff must avoid in such situations
  • Four critical elements of a compliance program — put these on your “to do” list today
  • Best practices for documentation and training of promotions and communications staff 

ake certain you maintain medical device off-label promotion compliance and avoid serious penalties — order now!

This audio CD/transcript is a must for positions in device and diagnostics companies, including:
  • Compliance officers
  • Executive management
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales and marketing personnel
  • Training personnel
  • Medical science liaisons
  • Outside attorneys
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

James Ravitz, partner at Arent Fox LLP, focuses on food and drug law, healthcare, consumer product safety and advertising. He represents manufacturers and distributors in obtaining approval to market medical devices, drugs, food, dietary supplements and cosmetic products. Additionally, James counsels on all aspects of the marketing of such products, including labeling, advertising, manufacturing and distribution. He is a frequent speaker at industry events, and has been published in multiple trade publications. James earned his J.D. from the Boston University School of Law.

Alana Wexler focuses her practice on fraud and abuse counseling and investigations, including defense of allegations of False Claims Act, Anti-Kickback and Stark Law violations. She also advises a diverse group of clients on implementation and audit of corporate compliance programs and government imposed corporate integrity agreements, including oversight of internal investigations. Before joining Arent Fox, Alana was senior counsel with the US Department of Health and Human Services, Office of Inspector General (OIG). Alana earned her J.D. from Rutgers School of Law.

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