Citizen Petition Advises FDA To Convene Advisory Committee On Communications
This article was originally published in The Pink Sheet Daily
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The Coalition for Healthcare Communication's March 31 citizen petition recommends FDA convene a communication advisory committee to ensure FDA review of drug promotions is based on social science. "FDA is a science-driven agency....Where's the science? Where's the social science?" Manning, Selvage & Lee VP-Global Health Affairs Peter Pitts said at a briefing on the citizen petition. Pitts added that when it comes to FDA's review of direct-to-consumer advertising, "there is no social science. They are using judgment." "People at FDA generally have very good judgment, but you can't look at an ad one time and deal with it one way, and look at another ad and deal with it another way," Pitts said. Pitts, FDA associate commissioner for external relations from 2002 to 2004, said the agency understands communications are a weak point. Pitts first proposed a communication advisory committee at FDA's public hearing on DTC advertising in November 2005. CHC Executive Director John Kamp added that FDA has been "very subjective and inconsistent" in its application of advertising laws. According to CHC, the advisory committee should comprise experts from consumer protection agencies, consumer and behavioral science experts from industry, and academia. The experts "would better inform the FDA on science and practical aspects of consumer behavior and contribute to the FDA's standing in the legal community," the petition states. The petition recommends former Federal Trade Commission Chairs Timothy Muris and Robert Pitofsky as candidates to chair the committee. Kamp held up FTC's handling of product advertising as a positive example of consistent and standardized rulemaking: "If I'm working with a company that has an ad they want to run, and I have to help them decide whether or not it's going to meet the standard of false and misleading by the FTC, I can do it pretty well," he said. "When I look at ads people bring me and I'm trying to figure out if the [Division of Drug Marketing, Advertising & Communications] staff is going to consider it false and misleading and fairly balanced I can't do that as well," he said. "We should be able to anticipate what's going to make it and what's not going to make it." Washington Legal Foundation has made efforts to contribute to better FDA communications oversight. The group's "DDMAC Watch" advertising regulation watchdog disputes warning and untitled letters from the ad division (1 (Also see "Strattera Ad Division Letter “Unsubstantiated,” WLF Says" - Pink Sheet, 22 Jun, 2005.)). CHC's proposals were formulated with the advice of a board of advisors comprising representatives from the advertising industry. Kamp noted that while the Pharmaceutical Research & Manufacturers of America "helped us think it through," the citizen petition isn't endorsed by PhRMA. "This is an initiative by the communication companies that work with pharma companies to do their ads. I don't think PhRMA would object to this," Kamp said. -Turna Ray |