8/9/2012 7:38:36 AM
Some physicians have no patience for sales reps who provide incorrect information. So when two Forest Laboratories sales reps last October visited a doctor to discuss the Daliresp medicine for chronic obstructive pulmonary disorder – but minimized the risks, failed to property describe its usage and misleadlingly broadened the indication – the doctor dropped a dime. Who was on the other end of the line? Drum roll, please… The FDA Bad Ad Program. And so, the FDA sent a stern untitled letter last week that cited what the reps did wrong. For instance, the reps responded to “direct questions about the risks of weight loss and psychiatric events, including suicidality in a manner which is consistent” with the product labeling, but “these risks were immediately downplayed with anecdotal claims regarding other physicians who have prescribed the drug, were pleased with it, and were not reporting any adverse events.” They also minimized the risk of weight loss by suggesting this may actually help COPD patients who are overweight.
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