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Fda Eases Restrictions For Drug Ads On TV Move Is Expected To Open Floodgates For Such Advertising

You’ve seen the TV ads, mystifying and strange, of a wind surfer gliding over fields of wheat. A serene mountain climber. A happy swimsuit-clad group going to the beach. A giant nose.

But, by law, the ad doesn’t tell you just what it’s advertising. Sporting equipment? A new car? Actually, they’re all ads for prescription drugs. Antihistamines, high-blood-pressure medicine and, in the case of the swimsuits, toenail fungus medication.

On Friday, the Food and Drug Administration effectively put an end to the confusion by easing TV advertising restrictions on drug companies. Prepare for an onslaught: The move is expected to open the floodgates of TV drug advertising.

Drug companies and ad agencies are expected to more than double the amount they spend on advertising next year to $1 billion. They insist that the new rules will mean not only more, but clearer ads and better information for consumers.

“Until this morning, a pharmaceutical company couldn’t use both the name of the drug and tell, straightforwardly, what the drug is for,” said John Kamp, an attorney for the American Association of Advertising Agencies, which has been lobbying for the change for years. “Under today’s ruling, people won’t have to scratch their heads and wonder what the ad is for.”

Victoria Murphy, a spokeswoman for Eli Lilly & Co. said that as a result of Friday’s ruling, the company is considering a TV campaign for Prozac, the popular antidepressant. The company has already launched an extensive print ad campaign.

“TV advertising is potentially beneficial, particularly in disease categories that are pervasive and under-treated,” Murphy said. “Two out of three people with depression, a highly common and highly treatable disease, do not receive adequate treatment.”

Advertising, she said, is one way to get depressed people, or their friends or family, to recognize symptoms, get to a doctor and get treated.

But some consumer groups say the FDA’s ruling is potentially dangerous. They say the coming barrage of drug ads could lead to patients asking for drugs they don’t need, or that cost more, and to physicians’ overprescribing drugs. They worry that the ads may gloss over the risks of drugs or their side effects.

“The major purpose of advertising is to sell drugs; it’s not to educate people about drugs,” said Larry Sasich, a pharmaceutical doctor and researcher at Ralph Nader’s Health Research Group in Washington.

“With the new FDA rules,” Sasich said, “I see patients who have been misled going to see physicians who have been similarly misled by drug advertising getting drugs that they may or may not need, and wind up potentially harmed either economically or personally.”

In fact, information about possible harmful side effects was the reason why the 30-year-old FDA rules were so stiff and the drug ads so oblique. Under the old rules, drug companies could advertise “direct to consumers” the name of the drug and what condition it was meant to remedy, but only if it listed lots of technical data about risks, clinical studies and potential side effects.

In print ads run in newspapers and magazines, all that mind-numbing information is squashed into tiny fine print at the bottom of the ad, and usually ignored by readers. But on television, drug companies complained there was no way to put all that data on the air in a 30-second spot. To get around it, drug companies ran “reminder” ads, that showed either a drug name, or the condition it remedied, but not both.

Thus, Friday’s ruling lifts the requirement that companies run tediously specialized data on air. Instead, drug companies will be required to broadcast a drug’s major side effects and risks, in a way that is easy for viewers to understand, and direct consumers to a toll-free telephone number, Internet web site or readily available brochures for more information.

“The ads are required to have a balance of the benefits and the risks, so consumers are not going to get a one-sided view, thinking this drug is the best thing since sliced bread,” said Ilisa Bernstein, an FDA senior policy adviser who helped drafted the new TV advertising rule and is at work to revise the rules for print ads. “Right now, you’re not getting the full picture in the ads out there.”


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