- The Washington Times - Tuesday, November 1, 2005

University researchers yesterday urged the federal government to require more prominent placement of prescription drug’s risks in advertising.

The suggestion came at the start of a two-day public hearing by the Food and Drug Administration, the federal agency that regulates prescription-drug sales and advertising.

The agency said it would listen to recommendations as it considers consumer advertising policies for medical products, which include prescription drugs, vaccines and medical devices. But the agency had no immediate plans to issue any new rules.

Duke University associate professor Ruth Day, who studies consumer understanding of drug ads in the university’s psychology department, said the drug industry must provide information about risk in a consumer-friendly format displayed prominently in the ad.

“The risk information is physically present, but functionally absent,” she told FDA panel members yesterday.

But the pharmaceutical industry argued it adequately informs consumers about risks.

“[Direct-to-consumer] advertising is not — and should not be viewed as — a comprehensive health information source that leads consumers to think they don’t need any more information,” said Patrick Kelly, president of U.S. pharmaceuticals at Pfizer Inc., a New York pharmaceutical company.

Despite the jump in the number of drug ads in the past decade, 71 percent of consumers said they rely on their health care provider as their main source for drug information, according to a 2004 online poll by Time Inc., a New York media company, and Harris Interactive Inc., a Rochester, N.Y., market research firm.

Pfizer and other major drug manufacturers signed onto a set of 15 guidelines issued in August by the Pharmaceutical Research and Manufacturers of America, a Washington trade group.

The voluntary rules included receiving preapproval from the FDA before running a new drug ad. Pfizer went beyond the rules by saying it would wait at least six months before marketing a new drug.

Other findings released at the hearing included:

• In a 2005 sample of popular drug ads, the information about a drug’s benefits on average reached a sixth-grade reading level while the risks were at an eighth-grade level, Ms. Day said.

• Celebrities in the prescription ad boost the memorability of the ad among the public, but not the overall importance of the ad or its believability, according to a recent study by Gallup & Robinson Inc., a Pennington, N.J., marketing research firm.

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