The FDA is issuing fewer enforcement letters to companies over drug promotions in 2016 than in previous years, a top FDA official said Sept. 27.
Speaking at a Food and Drug Law Institute conference in Washington, Thomas Abrams, director of the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP), acknowledged that there “are not a lot of enforcement letters so far this year.”
The OPDP issues warning letters and untitled letters to companies for drug marketing that doesn't meet the truthful, balanced and not-misleading promotional standard.
An untitled letter cites violations that don't meet the threshold of regulatory significance for a warning letter, according to the agency's regulatory procedures manual. Such letters often are used for drug promotion violations.
As of Sept. 16, the OPDP had issued only four enforcement letters in 2016 for drug marketing violations (14 PLIR 1314, 9/23/16). Three of those were untitled letters and one was a warning letter. In 2015, OPDP issued a total of nine enforcement letters.
Abrams stressed that the decrease in the numbers of letters being issued doesn't mean a lower level of enforcement on the agency's part.
Warning and untitled letters are “just one component of our multi-faceted approach to achieve the objective of having nonmisleading, truthful, and balanced promotion,” he said.