What’s the difference between legal and illegal promotion of off-label uses?

Many drug and device companies don’t know the right answer.

Miscues with off-label promotion are nearly always the result of weak (or nonexistent) training that assures it’s only a matter of time until a promising promotion strategy turns in to a legal nightmare – a nightmare that can result in fines, criminal penalties and liability lawsuits involving millions, even billions of dollars.

Here’s what you need to know NOW to avoid a call from the FDA’s Office of Criminal Investigations about an off-label violation.

This report is the clearest and most practical training available today for avoiding problems with off-label promotion.

Step-by-step, in plain English, it tells what drug- and devicemakers must do to navigate between legal and illegal dissemination of off-label use information … and minimize product liability concerns.

Buy now to arm your marketing team, sales reps, training staff and others with the knowledge they need to promote your products — without the risk of off-label violations. Specifically, with this guide, you’ll learn:

• How off-label promotion is defined — and the regulations and penalties that are associated with noncompliance
• Real-world examples of “implicit off-label marketing traps” and how to spot and avoid similar traps in your own promotions
• What constitutes allowable vs. unallowable communications used to discuss off-label product uses
• Best practices for minimizing the risk of off-label promotion violations
• Tips on creating an effective off-label promotion compliance program and training
• And more

Buy Now!
Offered by FDAnews in print or PDF format for $377.

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