Researchers To Ask FDA Panel To Require Rx Drug 'Fact Boxes' On Some Advertisements

Main Category: Pharmacy / Pharmacist
Also Included In: Public Health;  Regulatory Affairs / Drug Approvals
Article Date: 02 Mar 2009 - 1:00 PDT

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Two researchers from the Dartmouth Institute for Health Policy and Clinical Practice on Friday plan to push an FDA advisory panel to adopt a "drug fact box" labeling system for print prescription drug advertisements that quantifies the benefits and risks of taking a drug, the New York Times reports. The fact boxes would be similar in concept to nutrition fact panels on food packaging. The advisory committee will be examining ways to best provide consumers with accurate data.

Federal law requires that drug advertisements include a brief summary about the possible side effects of a medication and about risks for certain people who should not take the drug. However, "ads are not required to -- and seldom do -- spell out how well a drug works or how often volunteers in clinical studies had side effects," according to the Times. Critics contend that the current method of "risk communication" is misleading because ads do not include effectiveness statistics. Critics say that current ads could influence people to seek prescriptions for drugs that have limited benefit, or that the lack of details about side effects could lead people to avoid highly effective drugs if they overestimate the risk.

Steven Woloshin, a general internist and researcher at the institute, and Lisa Schwartz, also of the institute, plan to present findings from two randomized studies showing that most people presented with comparative risk and benefit information through the fact boxes were able to identify which drug was more effective between two drugs. The studies were published last week in the Annals of Internal Medicine. Woloshin and Schwartz will urge the panel to require the fact boxes to appear on printed material such as magazine advertisements, as well as on FDA's Web site. Woloshin, said, "We thought, if you could do it for Cocoa Krispies or Diet Coke, why couldn't you do it for Lunesta or other drugs?" (Singer, New York Times, 2/26).

The studies are available online.

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