Healthy Skepticism Library item: 17973

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Elliot S
Proposed Changes to Ad Rules
The New York Times 2004 Feb 5

Full text:

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.

“Asking the industry to talk about the risks in a more consumer-friendly way is just enlightened,” he added. “Consumers want these ads, refer to them and rely on them, so if they talk about benefits and side effects in language most people can understand, consumers can adequately discuss the drugs with their doctors.”

Daniel L. Jaffe, executive vice president of the Association of National Advertisers, who is the head of its Washington office, echoed that praise.

“We’re pleased the F.D.A. is now focusing on consumer comprehension rather than believing that providing an enormous amount of data will somehow solve the problem,” he said. “The consumer may be overwhelmed by the information, which is really set up to educate doctors.”

That was a reference to the fact that the patient information in print ads often repeats verbatim the material on product risks that drug makers provide to health care professionals.

“Though the ads provide everything you want to know about the drug, the type is so small it’s off-putting,” said Val DiFebo, managing partner at Deutsch in New York, an agency owned by the Interpublic Group of Companies that creates campaigns for Novartis prescription drugs like Lamisil, for toenail fungus, and Zelnorm, for irritable bowel syndrome.

“The challenge to the advertiser, to the agency, is how to do it in a way that energizes people to read the information, which is communicated in a way they understand,” she said.

Ms. DiFebo said she was not sure whether designing a print ad to feature a boiled-down version of the risks inside a box was “the right solution” because “the box could become a beacon: ‘Everything you don’t want to read is in here.’ “

John J. Beni, vice chairman at Parade Publications in New York, the unit of Advance Publications that publishes the Sunday newspaper magazine Parade, said it was too soon to assert what changes would be the most effective.

“Let’s figure out a way to redraft the ads so people will actually read the stuff,” Mr. Beni said, referring to the risk information. He added that he was not worried that important data was “going to go away” as a result of the proposed changes.

Nor is Mr. Beni concerned, he said, that any revisions will result in “more or less revenue” for Parade, adding: “The question is, How can drug makers communicate better in print? If they can communicate better, maybe they will communicate more.”

Parade will sponsor a conference in New York on Tuesday to discuss the proposals, at which executives from two agencies specializing in drug campaigns are to display examples of what ads based on the new guidelines may look like.

Another proposal made by Dr. McClellan yesterday involves the regulation of commercials known as reminder ads, which promote drugs by brand name but do not mention the ailments they treat. Under current rules, such commercials can run without describing the drugs’ risks.

Some drug makers have capitalized on that by closely preceding or following reminder ads with other ads that discuss the need to treat certain ailments without mentioning drugs by brand name. Those commercials, too, can run without risk disclosures.

The proximity of the two types of commercials – paired as bookends, as they are called – has been attacked by critics as exploitive.

The proposals envision regulating bookends, possibly using criteria like how much time separates the two types of ads and whether viewers consider them “perceptually distinct” or intrinsically related.

A third proposal from Dr. McClellan calls for rules for commercials that promote major medical devices like pacemakers, which are becoming more frequent and are not regulated.

The proposal would require a prominent statement of substantial product risk and would require that viewers be directed to other sources of risk information, like print ads.