- The Washington Times - Wednesday, November 2, 2005

Consumer groups yesterday called for tighter restrictions and even a ban on some prescription drug advertising.

The consumer groups testified at the second day of public hearings before the Food and Drug Administration, the federal agency that regulates prescription drug sales and marketing.

The FDA did not say when it would announce any changes to its advertising rules.

While an outright ban on drug advertising is unlikely, Commercial Alert, a Portland, Ore., group that monitors the advertising industry, urged FDA panel members yesterday to consider banning drug ads directed at consumers.

“By law, only doctors may prescribe prescription medicine. There is no legitimate purpose in advertising what consumers may not directly purchase. For this reason alone, [direct-to-consumer] advertising should be prohibited,” said Gary Ruskin, the group’s executive director.

Public Citizen, a Washington consumer watchdog group, urged the FDA to restrict celebrity endorsements of prescription drugs and drug ads aimed at children and teens.

The drug and advertising industries shot back, contending that drug ads help consumers have informed conversations with their doctors about previously undiagnosed medical conditions.

A 2002 FDA study has shown that ad-driven doctor visits help patients identify previously unknown medical conditions. About 87 percent of patients in the study, who visited their physician after seeing a drug ad and asked for the specific drug, had the medical condition the drug treated.

Most critics of drug advertising “are upset because they believe the advertising is causing a rise in the usage of prescription drugs,” said Wally Snyder, president and chief executive of the American Advertising Federation, a Washington trade association.

But increased drug usage, when appropriately prescribed by doctors, “means more patients are getting needed treatment,” Mr. Snyder said.

The Pharmaceutical Research and Manufacturers of America, the drug industry’s trade group, stepped up its self-policing efforts in August when it announced 15 guidelines for drug advertisers to follow. The voluntary rules included getting prior approval from the FDA for new drug ads. So far, 26 drug companies have agreed to abide by the rules.

In addition, New York City drug giant Pfizer Inc. said it would wait six months before advertising a new drug in order to educate doctors about its use and side effects.

Consumers Union, a Yonkers, N.Y., consumer advocacy group, argued that type of rule should be extended to a two-to-three-year hold on ads for drugs that are newly approved by the FDA.

Bill Vaughan, the group’s senior policy analyst, cited Vioxx, the arthritis painkiller pulled from market more than a year ago, as an example of drugs that should be further researched for side effects before being marketed. Merck & Co. Inc. heavily promoted Vioxx until an internal company report found that the drug increased the risk of heart attacks and strokes in patients who took it for 18 months or longer.

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