A new Food and Drug Administration proposal now aims to improve how these risks are presented in direct-to-consumer (DTC) ads in print or other media. The proposal opens up a whole new set of questions, according to Elizabeth Watkins, PhD, a professor of anthropology, history and social medicine at UC San Francisco.
Elizabeth Watkins, PhD
In a perspective published by the New England Journal of Medicine on Aug. 26, Watkins and co-author Jeremy Greene of Johns Hopkins University School of Medicine shared a historical perspective of DTC pharmaceutical marketing. “This is a long-standing question about how much and what information should be shared,” said Watkins, who’s also vice chancellor of Student Academic Affairs and dean of the Graduate Division at UCSF. “What do consumers have the right to know about the drugs they’ve been prescribed?”
Patient package inserts – the tiny sheets folded inside packs of prescription medication – were only introduced in 1970, 10 years after birth control pills came onto the market, when a series of high-profile Senate hearings revealed the risks linked to taking the Pill.
Catchy splashes in print media began in 1985, when the FDA allowed drug makers to market directly to consumers if the ads included “a fair balance of information.” Most ads simply reprint information aimed at medical professionals, Watkins explains, and the complex terms and tiny fonts make this fine print practically useless to patients.
With the new proposal, the FDA aims to present drug risks in simpler ways, similar to “Drug Facts” for over-the-counter medicines or nutrition labels on food.
But what the new fine print might be – and how useful it will prove – is still being debated. In comments on Watkins’ NEJM perspective, several physicians called for a ban on direct-to-consumer ads, describing them as a “scourge” that has made clinicians’ jobs tougher.
Watkins, however, believes that consumers need to be active participants in their health care, and more information may help people make better-informed choices.
“DTC advertising is contested, but that cat was let out of the bag 30 years ago,” she said. “The problem is not necessarily the ads themselves, but that pharmaceutical manufacturers may not provide balanced information. This new proposal is an opportunity for the FDA to play a much stronger role in helping consumers get the real story behind the flashy drug ads.”