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. Addenda: Radio Ad Revenue Was 1% Higher in 2003 (February 5, 2004)



Food and Drug Administration

Drugs (Pharmaceuticals)


Marketing and Merchandising

Research Company


Proposed Changes to Ad Rules


Published: February 5, 2004

THE Food and Drug Administration is asking the makers of prescription drugs to shun the obfuscation, so to speak, by proposing revisions of its regulations on advertising directly to consumers. The proposals encourage the ads to describe significant risks the drugs may pose in language that is clearer and easier for patients to understand.


The most notable aspect of the proposed changes, among several announced yesterday after months of study by the F.D.A., is the potential replacement of full-page advertisements for prescription medications in newspapers and magazines that now detail, in small type, information about effects and effectiveness.

Including such information is the quid pro quo drug makers must accept if they want to run ads promoting products for specific treatments in publications that are read by consumers rather than health care professionals. It is the print equivalent of the announcer in televised drug commercials who lists the risks in soothing tones at odds with the nature of the words.

The F.D.A. commissioner, Dr. Mark B. McClellan, suggested that drug makers produce ads that are more reader friendly by concentrating on the most common or important side effects. For instance, print ads might summarize the most important risks in bigger type highlighted by bullet points.

"The general idea from all our research is that less may be more," Dr. McClellan said in a phone interview before he described the proposals at a news conference in Washington.

"The goal here is to make sure the F.D.A. is doing all we can to make sure prescription drug promotion is as clear as possible," he added. "If we're going to have advertising, people must come away with a clear sense of what the risks and benefits are."

Critics of letting drug makers pitch prescription products to consumers as well to doctors are worried, however, that the concept of less being more could end up being, well, less.

"I would be in favor of it if the F.D.A. also required as it does now the full labeling," said Dr. Sidney M. Wolfe, director of the Health Research Group at Public Citizen in Washington, an advocacy organization, referring to the patient information. "I'm worried about taking out the full labeling."

The proposed changes would update guidelines issued by the F.D.A. in 1999 to address prescription drug advertising directed at consumers, which has grown into a $2.6-billion-a-year business.

Studies done by advertising agencies and media companies, as well as by government agencies and drug companies, have found that allowing such ads encourages consumers to ask their doctors about conditions, to get treatment for problems and to take prescribed medications as directed.

But research has also found that drug ads prompt some consumers to ask for treatments they may not need, which may be prescribed by doctors reluctant to deny patients what they ask for. Advocacy organizations have complained that many direct-to-consumer ads play up the potential benefits of expensive prescription drugs while playing down their possible harmful effects.

The changes affecting the print ads "sound like a great idea, but they could open the door to abuse," said Representative Henry A. Waxman, a California Democrat who complained last week that the F.D.A. was dragging its feet on enforcing regulations already in effect.

"If consumer warnings about 'acute liver failure' are replaced by language saying 'it can affect your liver function,' that's not consumer friendly," Mr. Waxman said. "That's misleading the consumer."

Executives at associations representing advertising agencies and marketers were more sanguine about the proposals, which were issued by the F.D.A. in draft form for public comment.

"The new guidances are exactly the kind of leadership we like to see from a regulatory agency," said Adonis Hoffman, senior vice president and counsel at the Washington office of the American Association of Advertising Agencies.

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