Calling for a moratorium, rather than just restrictions, on such advertising might be in order, say the authors of a study in the Aug. 16 issue of the New England Journal of Medicine.
Total pharmaceutical industry spending on promotion soared from $11.4 billion in 1996 to almost $30 billion in 2005. During that time, spending on direct-to-consumer advertising increased by 330 percent, yet this type of advertising only made up 14 percent of total promotional expenditures.
These mass-media advertising blitzes generally start before a drug's safety track record has been established in the marketplace, the researchers said.
"For the majority of heavily advertised drugs, direct-to-consumer advertising starts within about a year of FDA approval and typically well before the safety profile has been established," Donohue said.
The antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which include Celexa, Paxil, Prozac and Zoloft, led the field in promotional spending with more than $1 billion spent in 2005. Next were statins ($859 million), then proton pump inhibitors ($884 million).
At the same time, Donohue stated, "The FDA's monitoring of drug advertising has not kept pace with the volume of advertising of prescription drugs. The number of warning letters going out to drug companies has decreased markedly [from 142 in 1997 to 21 in 2006], and the number of FDA staff responsible for ads was relatively flat in recent years, in spite of spending increases."
It may be that the rules themselves are sufficient, but that enforcement powers are not.