FDA Threatens Criminal Prosecutions at All Levels

Author: Maureen Shaffer

Speaking at an industry trade conference this week, FDA Deputy Chief for Litigation, Eric Blumberg, made it clear the FDA will target pharma executives for criminal prosecutions with the rarely used Park Doctrine should their firms engage in off-label promotions because “it’s clear we’re not getting the job done with large, monetary settlements.”

Key Takeaways excerpted from the original Bloomberg News article:

• “…industry executives shouldn’t wait until the first charges are brought to bring their marketing into compliance.”
• “If you’re a corporate executive or are advising a corporate executive, now is the time to comply. That conduct may already be under the criminal microscope.”
• “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Clearly, the launch of www.goodpromotionalpractices.com is timely.  Learn more about how to in our resources section:

Article:
Practical Compliance Advice from Recent CIAs (Epstein Becker & Green, P.C.)

To keep up with the best in Good Promotional Practices, subscribe to our GPP RSS feed, our Facebook page, our Twitter stream or our LinkedIn group.