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Medical Device and Drug Defects

Janicek Law > Medical Device and Drug Defects

FDA responds to Big Pharma’s Citizen Petition

Big Pharma asked the U.S. Food and Drug Administration to overhaul a newly finalized regulation that gives the agency wide latitude to police off-label promotion. Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization and a drug maker coalition known as the Medical Information Working Group, filed the petition on February 8, 2018.  The petition claims the rule contains unconstitutional policy changes. These organizations represent many drug makers, and their petition challenges the FDA's new rule for evaluating “intended use” of prescription drugs and medical devices.  An important concept, intended use helps the FDA assess whether companies are intentionally marketing products for unapproved uses. The...

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