The investment in direct-to-consumer promotion of prescription medications in the United States now exceeds $US4 billion annually and continues to grow, amidst concerns about a low level of FDA scrutiny over advertising standards.
A recent analysis said direct-to-consumer promotion on television was first permitted in 1996. Studies had shown that such advertising increased total sales of drugs within a class and could help avert the underuse of medications in chronic disease, but also led to over-prescribing of some treatments.
Concerns had been expressed that clinical trials required for drug approval were not designed to detect rare but significant adverse side effects. Experience with medications such as rofecoxib suggested that widespread promotion should proceed more cautiously, waiting until better data from postmarketing surveillance was available.
Against this background, FDA supervision of direct-to-consumer advertising appeared to have relaxed. Only 21 letters about violations (minimising risks or exaggerating benefits) were sent to manufacturers in 2006, compared to 142 in 1997. Close analysis suggested the decline resulted from a weakened FDA, rather than better standards among advertisers.
Annual expenditure on direct-to-consumer advertising had increased more than three-fold since it was first introduced. It represented only 14% of total promotion budgets, but was growing faster than traditional activities such as detailing health professionals and providing samples.
The proportion of promotional budgets devoted to consumers was highest for proton pump inhibitors, statins and erythropoietin, where it accounted for more than 30%. The proportion was close to 10% for SSRI or SNRI antidepressants, antipsychotics and anticonvulsants, 1-4% for ACE inhibitors and calcium channel blockers, and zero for angiotensin receptor blockers.
More information was needed to fully assess the societal costs and benefits of this type of promotion, particularly as bans on direct-to-consumer advertising had recently been challenged in the European Union and Canada.
Reference
Donohue, J. Cevasco, Rosenthal, M. et al. 2007. 'A decade of direct-to-consumer advertising of prescription drugs.' New England Journal of Medicine vol. 357, pp. 673=681.
Abstract