Is this a violation?

[anonymous]

If a VP of commercial operations says that you can talk about any word mentioned on the package insert when talking with a Dr even if we don't have an indication for that word - is that illegal?

I have heard it is harder to bring off-label suits now but is it still done?

 

[Constantine Cannon]

It may be difficult to assess whether that specific practice is unlawful because this type of analysis is typically quite fact specific. Broadly speaking, pharmaceutical companies may not promote their drugs for uses, doses, or populations not specifically approved by the FDA as safe and effective. This could include, for example, if a drug is approved for use in treating severe psychiatric disorders, and the drug company’s sales representatives promote it for widespread use in calming elderly patients in nursing homes. Our law firm has compiled a list of successful enforcement actions involving off-label allegations that may be of interest to you: https://constantinecannon.com/tag/off-label/.

The information contained herein is for informational purposes only and is not legal advice or a substitute for legal counsel. Online readers should not act upon this information without seeking professional counsel. If you would like more information, or would like to speak to a member of Constantine Cannon’s whistleblower lawyer team, please contact us for a Confidential Consultation: https://constantinecannon.com/practice/whistleblower/team/.