Advocates, Industry Await PDA Response on Direct-to-Consumer Drug Marketing

In a decision that could have significant consequences for public health, the Food and Drug Administration (FDA) is considering revisions to the rules governing drug labeling and marketing. Given the Bush administration's record, public health advocates are concerned that the agency will accede to drug makers' demands for further curbs on its oversight authority, setting the stage for more debacles along the lines of menopause hormone therapy and the misinformation that steered millions of women to take it for years.

The Network was one of more than 600 organizations and individuals that submitted comments to the FDA last fall. In 1997, the agency had issued a guidance clarifying regulations for drug ads. This action triggered an explosion of direct-to-consumer (DTC) drug marketing, from less than $800 million in 1996 to more than $2.6 billion in 2001. Overall promotional spending by pharmaceutical manufacturers, including that directed at physicians, more than doubled from $9.2 billion in 1996 to $19.1 billion in 2001.

Amy Allina, the Network's program director, submitted comments to the FDA on behalf of the Network and Prevention First, a coalition of organizations including the Boston Women's Health Collective, Breast Cancer Action, the Center for Medical Consumers and DES Action. As a consequence of greater marketing, Allina wrote, "the regulations and policies that FDA has in place regarding such ads are falling short of the goal of ensuring that consumers get adequate and truthful information about advertised products, a key responsibility of FDA.

"Research shows that the ads are effective for their intended purpose, which is not to educate but rather to increase sales of the products they promote. ... [R]etail spending on prescription drugs was $155 billion in 2001, almost double what it was in 1997. And drug companies are reaping huge benefits from these sales. In 2001, pharmaceutical industry profits were 18.5 percent of revenues, significantly outperforming all other industries in the country." Allina's comments went on to illustrate the capacity of drug marketing to blur scientific facts and mislead consumers and doctors, as was the case with HRT.

More recent studies have confirmed the power of drug marketers' persuasion. In June, the Kaiser Family Foundation released the results of a study assessing the impact of DTC advertising on prescription drug spending. Looking at the year 2000, it found that every $ 1 the pharmaceutical industry spent on DTC advertising yielded an additional $4.20 in drug sales, and that these ads were responsible for 12 percent ($2.6 billion) of the total growth in drug spending. DTC advertising has increased an average of 28 percent annually from 1996 to 2001. For more on that study, go to www.kff.org/content/2003 / 6084/.

Defending such growth and calling for more, the pharmaceutical industry claims the FDA's marketing regulations violate drug makers' First Amendment rights to free speech. In its comments to the agency, the biggest drug lobby, Pharmaceutical Research and Manufacturers of America (PhRMA), submitted 35 pages of comments arguing that the PDA cannot "justify limitations on truthful, non-misleading speech about lawful products and activities" until it makes the case "that both the ends served and the means employed are legitimate and appropriately circumscribed." Many FDA regulations and policies, PhRMA went on, "have not been scrutinized through this First Amendment lens."

All this invoking of the Constitution has raised eyebrows, however, and there is strong support for stricter oversight of drug marketing. In an editorial published October 18, the New York Times warned the FDA "not to water down its rules in a way that would endanger public health." The FDA should not ignore "free-speech concerns" but "should also give considerable weight to the voices of public health advocates, who have warned against making changes just for the sake of deregulation or to satisfy someone's commercial interests."

As of mid-June, the FDA had not taken further action on this issue.