Big Pharma Challenges FDA's New Off-Label Rule

By Jeff Overley (February 9, 2017, 4:27 PM EST) -- Big Pharma is calling on the U.S. Food and Drug Administration to overhaul a newly finalized regulation giving the agency wide latitude to police off-label promotion, saying it contains abrupt and unconstitutional policy changes, according to a petition released Thursday.

The citizen petition was filed on Wednesday by Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization and a drugmaker coalition called the Medical Information Working Group. The three organizations collectively represent virtually all major drugmakers, and their petition challenged a Jan. 9 final rule that outlined how the FDA assesses the "intended use" of prescription drugs and medical devices....

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