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