FDA Acknowledges Decrease in Rx Promotion Violation Letters

Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....

By Dana A. Elfin

Sept. 28 — 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.

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.

Review Times Slowing

Abrams advised companies to build in extra time when they submit launch materials to OPDP.

OPDP receives 90,000 pre-launch promotional pieces for review each year, and its goal is to review companies' core launch materials within 45 days.

“We had been meeting that goal,” Abrams said, but recent submissions to the agency “have presented more complex issues requiring a deeper level of review and more consultation with our colleagues in different offices.”

“It's not like they're on the back burner,” he said. “We're digging down into complex issues.”

Abrams said companies should stay in close communication with the agency about their submissions.

“Talk to us about time frames,” he said, and “let your reviewer know that launch materials are coming.”

In addition, he said, companies should identify to the reviewer what the most important materials in the submission are, so the agency can work on those first.

He also said companies need to make sure their submissions are complete. “What we have seen sometimes are incomplete submissions including product claims without references or references that aren't annotated.”

Submission of unsupported claims really delays the process, Abrams said.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.