2017 OPDP (Formerly DDMAC) Sets Record Low for Warning Letter Issuance

January 10, 2018 FDAnews reports “OPDP Enforcement Letters in 2017 Hit Record Low… 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.”

Previously, on January 3, 2018 Michael Mezher reported in RAPS Regulatory Focus that “In the last days of 2017, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP). The warning letter brings the total number of enforcement letters issued by OPDP in 2017 to four (three warning letters and one untitled letter), a record low for the agency. While the number of OPDP letters sent each year has steadily declined since the late 90s, when the office routinely issued more than 100 letters per year, 2017 marks only the second time the office has issued fewer than 10 action letters.”

Here’s a link to the FDAnews story,  and here’s one to the story in RAPS Regulatory Focus.

Contact PDG for help with your FDA submission.

print