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...

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