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August 22, 2007

FDA to patients: Be afraid, be very afraid.

The FDA is leery about criticism that it isn't policing drug advertising enough, and some policy experts are concerned about drug spending. What to do? Apprently, make sure consumers don't have warm, fuzzy feelings about their meds.

Federal regulators plan to study whether relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks.

The announcement, posted Tuesday to the Food and Drug Administration's Web site, comes a week after a study published in the New England Journal of Medicine suggested the agency's drug-ad enforcement has steadily declined.

The FDA says it plans to study how 2,000 people react to television drug ads to determine whether they have an overwhelmingly positive impression of products despite audio warnings about potential side effects.

The article goes on to say that "critics charge that images of smiling and relaxed couples and families featured in ads overshadow audio warning about possible complications."

This is laughable, and wrongheaded. First of all, prescription drugs are not available without seeking the advice and guidance of a physician - who is deeply learned about the risks of medicines. Second, statistics seem to show that many, many more Americans are undertreated for chronic ailments like depression, diabetes, and heart disease. Insofar as positive advertisements get people to consult their doctors they are a boon.

Last but not least, it is a bad idea to "balance" risks and benefits in advertisements, which could leave consumers under the unhelpful and untrue impression that the drugs they may take to treat illnesses are as dangerous as the illnesses themselves.

Consumers should certainly be educated about the risks and benefits of prescription drugs. And there is a real moral hazard associated with insurance coverage that may lead to some overconsumption of medical goods and services, including branded prescription drugs.

But we cannot expect consumer advertisements to become drug labels, especially since expert advice and alternative sources of information (from Consumer Reports and WebMD) are widely available.

Posted by Paul Howard at August 22, 2007 03:51 PM

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