US FDA Advertising Citations Remain Rare In 2018
With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.
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In its second letter of the year, US Office of Prescription Drug Promotion says Xeris Pharmaceuticals’ television ad fails to include important risk information and misleadingly suggests Gvoke pre-filled syringe can be easily used.
The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.
An OPDP warning letter hits Galt Pharmaceuticals for misbranding its insomnia drug Doral with similar to concerns to those outlined in a 2014 untitled letter to the then-sponsor Sciecure.