5 Takeaways From FDA's Off-Label Promotion Guidance

By Jeff Overley (March 5, 2014, 4:12 PM EST) -- New guidance from the U.S. Food and Drug Administration clarifies how drugmakers and device makers can avoid illicit off-label marketing when sharing scientific literature about unapproved uses of their products, scrubbing away a few more gray areas surrounding enforcement practices that carry multibillion-dollar implications. 

The FDA's attempt to tie up loose ends comes at a tumultuous time for off-label promotion, which continues to factor into massive False Claims Act settlements while also being increasingly viewed as protected speech in some circumstances.

Here are five takeaways lawyers shared with Law360:

It's the Start of a Process

Friday's revised guidance came in direct...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!