FDA OKs Off-Label Petitions By Sidley Austin, Ropes & Gray

Law360, New York (June 9, 2014, 5:56 PM EDT) -- The U.S. Food and Drug Administration in a letter released Monday approved citizen petitions from Ropes & Gray LLP and Sidley Austin LLP related to off-label promotion of prescription drugs, agreeing to clarify several issues surrounding an activity that has led to billions of dollars in False Claims Act settlements.

In its letter, the FDA said it intends to issue guidances this year on permissible discussion of off-label uses through four avenues: scientific exchange, interactions with health insurance companies, dissemination of clinical practice guidelines and responses...
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