FDA’s Office of Prescription Drug Promotion (OPDP) Enforcement: A Summary of 2013 Warning and Untitled Letters

February 27, 2014

By Jennifer Romanski and Kim Capone


FDA’s Office of Prescription Drug Promotion (OPDP) issued a total of 24 enforcement letters to pharmaceutical manufacturers in 2013, 3 Warning Letters and 21 Untitled Letters. This is comparable to the 21 enforcement letters issued by OPDP in 2012. With respect to the types of violations, OPDP focused more on “Omission of Material Facts” this past year than it did in 2012. A full comparison of the most frequently cited violations for the last few years is contained within the summary with a breakdown by media or promotion type.

Please click here to read the full summary.

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