Delay in Drug Advertisements Advocated
AMA on Wednesday said that the federal government should require pharmaceutical companies to delay direct-to-consumer advertisements for new medications and medical devices until physicians have time to study their safety and effectiveness, the Chicago Tribune reports (Japsen, Chicago Tribune, 6/15). According to AMA, the time that pharmaceutical companies have to wait before they could begin DTC ads for new medications should depend on the availability other treatments for the same conditions and the severity of the conditions involved.
AMA also said that pharmaceutical companies should have to obtain FDA approval before they begin DTC ads. In addition, AMA said that DTC ads that feature actors who portray physicians are "misleading" and should require "a disclaimer" that is "prominently displayed."
AMA said that DTC ads often overstate the effectiveness of new medications and downplay the risks and side effects. Pharmaceutical companies spent more than $4 billion on DTC ads in 2004, the Chicago Sun-Times reports (Ritter, Chicago Sun-Times, 6/15).
AMA President-elect Ronald Davis, a preventative medicine specialist from Michigan, said, "A temporary moratorium on direct-to-consumer advertising of prescribed drugs and medical devices will benefit both the patient and physician." He added, "It's possible that companies could do it voluntarily with some coordination or oversight of their trade association, but failing that, the government should step in to put that policy in effect" (Chicago Tribune, 6/15).
Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "A huge proportion of ads contain false and misleading information."
However, the Pharmaceutical Research and Manufacturers of America said that under current guidelines pharmaceutical companies "spend an appropriate time" on the education of physicians before they begin DTC ads. PhRMA also said that required FDA approval before pharmaceutical companies begin DTC ads "might have the unintended consequence of unnecessarily delaying when patients hear of a new treatment" (Chicago Sun-Times, 6/15).
FDA spokesperson Susan Bro said that the agency believes a required delay on DTC ads for new medications likely would not "survive a constitutional challenge" (Chicago Tribune, 6/15).