Fine print sends the wrong message to consumers

For the most part, pharmaceutical companies have followed FDA guidelines to fully disclose potential risks and side effects on a drug’s labeling or advertising. What raises the hackles of some industry watchers is how companies present that information. Peter Pitts, senior vice president and director of health affairs for Manning Selvage & Lee and a former FDA associate commissioner criticizes, “Risks are hidden in plain view; the small print on the back of a DTC print ad is written at a graduate-school reading level.”

Graduate students may appreciate such weighty prose, but the general public appears to be turned off by the prospect of wading through reams of data printed in agate type. Pitts cites two consecutive FDA studies that found that, while the percentage of consumers aware of the risk information has increased, the percentage of consumers actually reading the risk information has dropped. “The metric is moving in the wrong direction,” he notes.

For its part, the FDA is tight-lipped about any potential changes to DTC guidelines. “We really don’t foresee any immediate changes in pharmaceutical advertising,” says FDA Public Affairs Specialist Crystal Rice.