UNCLEAR LABELING IS HINDERING FUTURE OF DTC ADS, CONSULTANT SAYS

The FDA and the industry must address inadequate brief-summary drug labeling to ensure that DTC ads protect public health, a prominent consultant says.

Drug advertising is failing to properly inform the public of risks because the brief-summary data, which disclose drug side effects, are not clear enough for the public to understand, Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, said. "Risk communication is neither designed or delivered to be user friendly," he told attendees Aug. 23 at the FDA Regulatory and Compliance Symposium at Harvard University, co-sponsored by FDAnews.

The problem is that industry develops this language with potential legal liability in mind, making these summaries too difficult to read. But making this information easier to understand without understating potential risks is "critical to the future success of DTC communication," he said.

To improve this situation, industry must stop seeing this language as a means of avoiding legal liability and instead use it as a public health tool. The agency must get involved to ensure that social science is used to assess how consumers read and understand this information and craft better summaries that are more user friendly, he added.

The data already exist, but neither the FDA nor industry take advantage of that. "More research is a poor excuse for a lack of action on this important public health issue," he said.