FDA's Office of Prescription Issues Record Low Number of Enforcement Letters in 2015

The number of enforcement letters from the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) has steadily declined in recent years, from 52 in 2010 to a record low of nine in 2015. While the quantity of letters has dropped, the OPDP is still active in its oversight and continues to warn companies that fail to disclose risk information and that fail to provide balance in their promotional messaging. This article examines the nine letters sent to drug companies last year, outlines the most common violations, and offers guidance on how to avoid a letter.

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