FDAnews Drug Daily Bulletin


Dec. 9, 2005

The FDA is considering using academic research into the way people process information to redesign the agency's website and improve its delivery of drug safety information to consumers, according to FDA officials.

The agency is thinking about such changes in response to criticisms that its risk-communication strategy is seriously flawed — a charge officials heard repeatedly during a recent meeting on the FDA's policies for communicating drug safety data.

Stakeholders attending the meeting told the FDA that its current strategies for communicating risk information, such as its website, drug labeling and patient information sheets, are inadequate. Specifically, these stakeholders, including academics and activists, said the data was confusing and, at times, misleading. The critics also noted that the FDA does not seem to understand how to communicate risk information so that it is easily accessible and understandable.

The FDA has made clear that improving risk communication is one of its highest priorities, with Center for Drug Evaluation and Research (CDER) Director Steven Galson calling it "one of the most important issues facing ... the agency." In his opening statement at the meeting in Washington D.C., Galson acknowledged that the agency has yet to come to broad agreement about which risk communication strategies are most effective.

In an effort to address these concerns, the agency is considering using the work of academics, such as Ruth Day of Duke University, to help craft a clearer message. Day studies the way people process information to determine how best to organize data so that an audience will understand it.

Day and other researchers have undertaken studies that test the consequences of providing information in different formats, and the FDA wants to use that expertise, agency Deputy Commissioner Scott Gottlieb told FDANews. The agency believes it can use such studies to redevelop CDER's website and other communication tools, Gottlieb added.

Other FDA officials agreed that this approach would help improve the agency's message. The FDA "needs to take a harder look" at the website, Paul Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Science, said during a panel discussion at the FDA meeting. The FDA's site was initially developed as a tool for the pharmaceutical industry, but now that more patients are using the site to access safety information, it needs to be redesigned and made more user-friendly, Seligman said.

Day has analyzed explanations of drug side effects and determined, for example, that messages using text and passive voice are harder to understand than bulleted points and other types of communication. For instance, using a matrix that identifies the frequency and severity of a side effect is much easier to understand than text alone, she said. The agency should consider educational campaigns using such methods to better communicate risks, Day recommended.