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

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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.

How can you minimize the risk of being investigated for an off-label promotion violation and ensure your promotional program is in compliance?

Sign up now for this 90-minute Encore presentation 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. 

Sign up your entire team to listen in and discover:

  • 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 

Make certain you maintain medical device off-label promotion compliance and avoid serious penalties — register now! You’ll get a chance to ask your toughest questions during the Q&A session.

This presentation 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

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.

Register now!

Date: June 30 – July 18, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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