A decade has come and gone since the FDA opened the floodgates to direct-to-consumer advertising. Since then, the amount spent to sell drugs rose 2.6 times what it was in 1996, the last full year before DTC began, according to a study published today in The New England Journal of Medicine.

The researchers wrote that DTC advertising, which increased by 330 percent during that period, only accounted for 14 percent of the nearly $30 billion the companies spent to promote their drugs - total spending reached $29.9 billion in 2005, up from $11.4 billion in 1996, an average annual growth rate of 10.6 percent.

But the FDA isn’t doing as much monitoring as in the past - the number of letters sent to drugmakers about violations fell from 142 in 1997 to only 21 in 2006. Why? “In 2004, four (FDA) staffers were reviewing such advertisements, even though spending on this form of advertising (and probably the volume of ads to review) had increased by 45 percent, from $2.9 billion to $4.2 billion,” the researchers wrote. For a chart, please keep reading….

As an example, they noted that 64 percent of the ads broadcast on TV in 1999 were reviewed by FDA staffers, but the ratio had declined to 32 percent by 2004. In addition, in 2002, when then-Secretary of Health and Human Services Tommy Thompson began requiring all warning letters to be reviewed by the FDA’s Office of Chief Counsel, the number of letters actually sent to manufacturers dropped by half, the study found. Please click on the chart to see a larger version.

Ultimately, the study authors offered a tepid and rather obvious conclusion: “Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it. Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices.”