Surge Of FDA Activity Caps Quiet Year Of Promo Discipline
Law360, New York (January 7, 2014, 4:37 PM EST) -- The U.S. Food and Drug Administration on Friday released a letter chastising Dara Biosciences Inc. for allegedly overstating the benefits and downplaying the risks of cancer drug Soltamox, joining a recent flurry of activity in what was an otherwise sleepy 2013 for promotion-related enforcement.
In its Dec. 20 letter, the FDA criticized marketing materials it said improperly suggested that Soltamox's liquid formulation made it not only more convenient but also likely to improve patient adherence to important medication.
In addition, the FDA complained that certain risks were omitted from a brochure, and that readers instead were directed to review a package...
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