FDA Issuing Fewer Rx Promotion Violation Letters


It’s not your imagination: The FDA is issuing fewer enforcement letters to companies over drug promotions in 2016 than in previous years.

There “are not a lot of enforcement letters so far this year,” Thomas Abrams, director of the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP), acknowledged at a Food and Drug Law Institute conference in Washington.

But the decrease in letters doesn’t mean companies can afford to stop monitoring their drug marketing campaigns.

Indeed, 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 multifaceted approach to achieve the objective of having nonmisleading, truthful and balanced promotion,” Abrams said. Other facets include developing guidance documents, reviewing draft product labeling and reviewing core launch materials.

“We will work on issuing guidances on promotional issues,” he said, with the goal of achieving voluntary compliance.

As of Oct. 3, 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 nine enforcement letters.

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.

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