As of the first half of 2019, the Office of Prescription Drug Promotion (OPDP) at the Food and Drug Administration (FDA) had issued only three Untitled letters. The low number of letters issued by OPDP continues the declining trend seen since the most recent peak in 2010. The decline, in part, is due to the Agency’s weariness around issuing letters for violations that may be protected by the First Amendment and risk-based enforcement approach, focusing on clear violations impacting health and safety. In addition, a significant increase in guidance released by FDA, voluntary guidance instituted by Pharmaceutical Research and Manufacturing of America (PhRMA), and improved industry self-regulation has also contributed to the declining number of letters.
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