A recent article in the New York Times describes the results of a study by Steven Woloshin and Lisa Schwartz, two researchers from the Dartmouth Institute for Health Policy and Clinical Practice, which showed that a drug-fact box improved US consumers’ knowledge of prescription drugs’ benefits and side effects. The researchers presented their findings at a recent meeting of a FDA Risk Communication Advisory Committee, urging the committee to adopt a drug-fact-box labeling system (similar to nutrition-fact panels on food packaging), which would be used in print prescription drug advertisements to quantify the benefits and risks of taking a drug.

Is such a suggestion good policy or an example of overregulation? Increasing the transparency of information and knowledge about drugs to patients is a positive development, but it does not come without some caveats on how to convey that information. The ability to succinctly present clinical information in the confines of a drug-fact box in a print ad would seem limited, but would fill a void in risk communication in drug advertising. Although current law requires drug advertisements to include a brief summary about the side effects and risks for patient types, they do not offer details on the drug’s efficacy or side-effect profile from clinical trials.

A drug-fact box that offers further detail on clinical risks and benefits is helpful, but the outlet for that information should be not be print advertising. A better solution would be to require physicians to provide patients with drug-fact boxes at the time of dispensing prescription drugs, so that a patient could review the information before deciding to take a drug and filling a prescription. Such a practice would allow patients to easily review drug information and to discuss any concerns with their doctors and to give them access to information before reviewing product insert information after a prescription is filled, which is typically the first time that a patient may review drug information in any detail.

Although the researchers discussed drug-fact boxes modeled after nutrition-fact panels for conveying clinical information, drug-fact boxes could also be used to provide ingredient information, similar to nutrition-fact panels on food packaging. Like nutrition-fact panels, the drug-fact boxes could be standardized and detail the active ingredient, excipients, manufacturers of ingredients (not just the pharmaceutical company but all producers involved in the product’s supply chain), and location of production facilities in which the ingredients were manufactured. The drug-fact boxes would be included in the product information with a dispensed prescription product. Requirements for such information have been recently debated in the context of proposed reforms in overseeing the pharmaceutical supply chain, most notably various versions of the proposed FDA Globalization Act.

Increasing access to and improving the quality of product information, whether it be for drugs, food, or other consumer products, is a good thing. A drug-fact box is an example of thinking “out of the box” to improve current practices.