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The Rule Of Law Is The Best Medicine: Part 2

Law360, New York (August 8, 2017, 11:46 AM EDT) -- The U.S Food and Drug Administration cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use — making the product misbranded. The tortured path of this ‘logic’ should, by itself, render this off-label regulatory regime questionable, but the FDA’s recent reaffirmance of it amounts to incoherent defiance....
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