FDA Official Reports Increase in Voluntary Ad Reviews
Thomas Abrams -- the director of FDA's Division of Drug Marketing, Advertising and Communications -- reported a "huge increase" in submissions from pharmaceutical companies for a new voluntary advertisement review program, the Philadelphia Inquirer reports. The Pharmaceutical Research and Manufacturers of America started the program in August in the hope of "pre-empt[ing] legislative restrictions" as the industry received heightened criticism over its advertising spending, according to the Inquirer.
The PhRMA code calls on drug makers to "avail themselves of the longstanding willingness" of FDA "to review ads in advance of airing or publication, to make sure they do not violate fairness and balance rules that can invite a warning letter," the Inquirer reports.
Ken Johnson, a senior vice president at PhRMA, said the increase in submissions "is a clear indication that the companies are following through."
Abrams, speaking at a conference sponsored by the Drug Information Association, noted the division has the same staff "handling a bigger workload" and declined to specify a time frame on how long it might take to review the submissions. He added that "it's too early to tell" if the new program will prevent violations (Ginsberg, Philadelphia Inquirer, 2/23).