Direct-to-consumer advertising of prescrip-tion drugs has come under pressure in the United States, with researchers suggesting that the Food and Drug Administration (FDA) has fallen behind in enforcement of laws regulating such advertising. A study of trends in pharmaceutical spending reveals a staggering US$29.9 billion spent on drug advertising in 2005, with spending on direct-to-consumer advertising increasing by 330% to over US$4 billion since 1996. In the midst of calls for tighter controls on direct adver-tising, the study shows that manufacturers of proton-pump inhibitors, statins, and erythropoietin medications spent about a third of their total marketing budget on direct advertising in 2005. New drugs developed to treat chronic conditions are the most likely candidates for this type of promotion, with most being advertised directly within a year of their introduction into the market. The authors comment that this may lead to increased use of drugs with uncertain safety profiles. A decline in the number of regulatory actions by the FDA against com-panies marketing direct to consumers has led researchers to speculate that the FDA has fallen behind in the task of reviewing and policing inappropriate and misleading advertising. They suggest that this may be the result of insufficient FDA staffing levels and the introduction of more complicated requirements before warning letters can be issued to pharmaceutical companies.
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