FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

OPDP Enforcement Letters in 2017 Hit Record Low

Jan. 10, 2018

The FDA’s Office of Prescription Drug Promotion issued just three warning letters and one untitled letter in calendar year 2017 — a record low and down from a high of 156 in 1998.

The trend since the early 2000s has been a steady decline in warning letters from the office, with an occasional spike. The OPDP issued just 28 letters in 2002, and that number dropped to a new low of 19 in 2007, followed by a slight increase. In 2011, it dropped again and decreased every year except 2016 until reaching the new low last year.

But the FDA maintains that the numbers don’t tell the full story, saying warning letters are just one component of the agency’s oversight activities.

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