Researchers view a weaker DDMACA 10-year review of DTC advertising by researchers from three major universities suggests that oversight of advertising by the FDA's DDMAC has declined dramatically.
Researchers led by Julie Donohue at the University of Pittsburgh Graduate School of Public Health reported in the New England Journal of Medicine that while the decline could reflect either better industry compliance with ad regulations or a worsening of FDA oversight, there are three observations that support the latter cause.
First, they wrote, the HHS secretary required the FDA to submit all draft regulatory letters for review and approval by the agency's Office of Chief Counsel, an action that the Government Accountability Office later found had led to a reduction in the number of letters and to delays that allowed misleading campaigns to run their course before an FDA Warning Letter could be issued.
Second, the number of DDMAC staff members dedicated to reviewing ads has remained relatively stable, while the use of such ads has grown substantially. In 2002, the researchers say, three FDA staff members were dedicated to reviewing DTC ads. In 2004, four staffers were reviewing ads, although DTC spending had increased by 45% from $2.9 billion to $4.2 billion.
Third, consistent with the hypothesis that staffing has not kept pace with the number of ads, the research said the proportion of broadcast ads undergoing DDMAC review before airing declined from 64% in 1999 to 32% in 2004.