• by Aaron Baar , April 3, 2008

As the issue of direct-to-consumer prescription drug advertising comes under more scrutiny, an advocacy group is calling for pharmaceutical companies to better state how consumers can report side effects from prescription drugs.

Consumers Union, the publisher of Consumer Reports magazine, says prescription drug ads should contain information about the Food and Drug Administration's MedWatch, the agency's program for reporting drug side effects.

"We're trying to help the FDA get information more quickly from the people using prescription drugs," CU media director Susan Herold tells Marketing Daily. "Once these drugs are in the market and used by millions of people, that's when you start to see side effects."

The call, which includes a petition signed by nearly 56,000 consumers, coincides with a new Consumer Reports poll showing that 16% of Americans have experienced serious side effects from prescription drugs. However, only 35% of those polled said they knew they could report those side effects to the FDA.

Information about the FDA's MedWatch program is already required on prescription drug print advertising, Herold says. "What we're saying is, 'The next step is to put it in television advertising'," she says.

According to the Consumer Reports poll, 81% of the respondents said they had seen or heard an advertisement for prescription drugs within the past 30 days. Nearly all of them - 98% -- said they had viewed an ad on television. Some 87% of the respondents said television ads should contain reporting information about reporting adverse reactions, according to the poll.

Earlier this week, a study published in the New England Journal of Medicine showed that cholesterol-reducing drugs Vytorin and Zetia have been prescribed four times as often in the United States than in Canada, despite questions about the drugs' efficacy in relation to older, more proven drugs. The authors of the study cited direct-to-consumer advertising - which is outlawed in Canada - as a primary factor in the prescription rate difference.

That information, along with highly publicized cases of adverse side effects, may prompt more calls for increased scrutiny of direct-to-consumer advertising, Herold says. "The more we learn about side effects, the more we think we'll see [the issue raised]," she says.