The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled. Pacira will be receiving essentially everything it wanted in a "favorable resolution," and the FDA is formally withdrawing its warning letter that attempted a retroactive reduction in the scope of the indications of Exparel's (the drug at issue) approval. Under the agreement, Exparel's label will be updated to say the drug is indicated for the treatment of pain at any surgical site.
To read more about the settlement and what it means with respect to truthful off-label promotion, read Jim Beck's post here, which was posted to the popular Drug and Device Law blog.
In addition to Jim's post, he was also quoted on the settlement in the December 15 Financial Times article titled, "FDA in pain drug restriction U-turn." (Subscription required).
This article is presented for informational purposes only and is not intended to constitute legal advice.
