FDA considers tightening regulations for direct-to-consumer advertising.

In August, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) sought to curb growing public criticism over its consumer advertising practices by releasing voluntary advertising guidelines. The document stated that drug advertising should serve the public health by “ increasing awareness about diseases ” and “ educating patients about treatment options. ” The voluntary PhRMA guidelines are viewed by some as an attempt to placate the U.S. Food and Drug Administration, which is considering tighter regulations on consumer drug advertising. In November, the agency held a 2-day hearing to solicit input from consumer advocates and the drug industry on how to proceed. Current guidelines, put in place in 1997, allow drug companies to advertise directly to consumers if such ads balance supposed benefi ts with possible risks. Drug companies must submit advertisements for FDA review only at the time of airing; the FDA has no power to force companies to preclear advertising, although some choose to do so. If the agency deems that an advertisement does not comply with regulations, it sends warning letters proposing changes to the ad. However, because the FDA guidelines are not full-blown regulations, the agency does not have the power to fi ne or otherwise sanction drug companies for running misleading ads. Beginning in January 2006, the United States will be the only country that allows direct-to-consumer drug advertising for pharmaceuticals. (New Zealand allows such ads through the end of 2005.) Consumer groups want Congress to grant the FDA the power to fi ne companies that run misleading advertisements. And many are skeptical of the sincerity of PhRMA’s new guidelines, citing past statements that undermine the notion that the drug companies see advertising as anything more than a means to boost its profi ts. “ The ultimate goal of [directto-consumer] advertising is to stimulate consumers to ask their doctors about the advertised drugs, and then ... get the prescription, ” two drug advertising executives wrote in 1998 in Medical Marketing and Media, a newsletter for their trade. “ They sell medical products just like any other products ... just like toys and cars and deodorant. The goal is to make us want them, ” said Diana Zuckerman, Ph.D., director of the National Research Center for Women and Families, at the November hearing. Recent statistics seem to support her claim. In 2000 and 2001, Merck spent $296 million rolling out its new (and ultimately ill-fated) arthritis drug Vioxx (rofecoxib), the largest amount spent on advertising for any drug in that period. The trade magazine Advertising Age rewarded Merck by naming Vioxx one of the top new “ megabrands ” ; that is, consumer recognition of the product was widespread. In 2003, the Kaiser Family Foundation published a report claiming that for every $1 spent on promotion, drug companies gained $4.20 in revenue. That same year, PhRMA said its members spent $25 billion on promotion, including advertising and free samples for physicians, and $33 billion on what the industry categorized as research. But social scientists and other observers remain divided over the impact on consumer behavior of direct-toconsumer advertising, which fi rst appeared as print advertisements in the mid-1980s and on radio and TV in 1997. An FDA study of public and physician attitudes toward the ads produced equivocal results. Only 4% of consumers in the survey said that a drug ad prompted them to visit a physician, and the survey “ did not fi nd strong support ” for the claim that ads led patients to expect a prescription. About half of the physicians in the survey reported feeling at least some pressure to prescribe a drug that a patient saw advertised.