The U.S. Food and Drug Administration is considering several policies that would require the use of a "drug facts box" in association with medication labels and pharmaceutical advertisements based on a study conducted by researchers at the Dartmouth Institute for Health Policy and Clinical Practice. The facts box is a summary of a drug's uses and side effects, similar to the nutrition labels on foods.
The top section of the box lists what conditions the drug can treat and who should take the medication. The bottom section describes the effectiveness of the drug as well as the percentage of patients who experience different side effects, Dartmouth Medical School professor Steven Woloshin, one of the study's authors, said. His co-authors on the study, published online in the Annals of Internal Medicine, were DMS professors Lisa Schwartz and H. Gilbert Welch.
The FDA currently requests that drug manufacturers provide consumer-oriented medication information to patients when they receive new prescriptions at pharmacies. The FDA began looking to replace this voluntary program in 2008 when a study showed that the fine-print consumer information did not consistently provide useful facts about drugs' uses and risks, according to FDA spokesperson Sandy Walsh.
Although Congress in 1996 called for information to be presented more clearly, the 2008 study found that stakeholders, including doctors and patients, still only considered about 75 percent information in the fine-print useful.
The Dartmouth team presented its research to the FDA risk communication advisory committee, which began considering possible replacements to the current FDA policy in February 2009.
In its study, the Dartmouth team asked consumers to choose between two heartburn medications, one of which was designed to be more effective than the other in controlling stomach acid production. Half of the participants were shown a drug facts box and the other half were shown the standard fine-print advertisement. While 31 percent of people shown the advertisement chose the more effective medication, 68 percent shown the drug facts box did so.
"One of the questions that always comes up is, 'Do people understand the information and statistics?'" Woloshin said. "I think the research puts those concerns to rest. People can not only understand the information given, but they actually use the information to compare drugs and choose the one that is better for them. Even people at lower levels of education were able to do this, and I think the committee was really gratified to see that."
The risk communication advisory committee unanimously urged the FDA in March to require that drug facts boxes appear on all medication labels.
Baruch Fischhoff, chair of the advisory committee, told The Boston Globe that he was optimistic the FDA would support the use of fact boxes either as its policy or as part of congressional legislation.
"The FDA is planning to meet with Woloshin and Schwartz again to discuss where the agency might continue to look at possible applications of the drug facts box," Walsh said.
Woloshin said he and his colleagues originally hoped the drug facts box would replace the fine print on commercials. The FDA, though, does not have the authority to require the boxes in advertisements, Walsh said.
The FDA could, however, require the facts boxes be submitted as part of the drug review process and display the box on its web site to make information more accessible to doctors and patients, Woloshin said.
"Any upcoming regulatory or legislative interventions would depend on what the FDA decides to do," Walsh said. "Since the voluntary system is not working the way it was intended to work, converting to a government-regulated system probably would entail rule-making and possibly new legislation."
