February 24, 2006

The FDA is making a major change to how it reviews DTC ads to account for an upsurge in the number of ads submitted since PhRMA's new advertising principle went into effect Jan. 1, agency officials say.

The FDA has decided to shift from reviewing ads based on when they arrive to focusing first on newer claims. Doing so will allow the agency to better handle a growing number of ads, which had been difficult given limited resources and staff turnover, agency officials said. The FDA has previously considered requesting more funding to address these submissions.

While the agency repeatedly said it is too early to tell what the effect will be of PhRMA's Guiding Principles on DTC reviews, the FDA has found it difficult to respond to these submissions within the 30-day period laid out by PhRMA, said Melissa Moncavage, head of the agency's DTC review group. The agency will begin making newer cases a priority to better handle these submissions, she told attendees at a recent Drug Information Association meeting on drug marketing.

Specifically, the agency will focus first on: ads for drugs that are new or have never been advertised on television; drugs used for new patient populations or new purposes; and instances where new risk information is available and where there are new effectiveness claims, said Thomas Abrams, the FDA's director of the Division of Drug Marketing, Advertising and Communications.

At issue is PhRMA's Guiding Principle No. 8, which says that companies "should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast." The group also suggested that the agency review these ads within 30 days.

The agency is currently reviewing its procedures, but believes meeting the 30-day review will be "challenging" because newer applications usually involve "the most intense reviews," Moncavage told FDAnews.

The FDA plans to complete the initial review of its handling of the PhRMA principle by June 1, said Moncavage.