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FDA Proposes Drug Ads Without The Fine Print

A new Food and Drug Administration proposal would let drug makers offer less detail in print ads about the risks of prescription medicines, but they would have to explain the most serious problems using language consumers can understand.

The plan, one of three related draft guidelines focused on direct-to-consumer advertising, is likely to reignite the debate over drug ads at a time when they are more attention-grabbing than ever.

Last weekend's Super Bowl ad lineup, which included commercials for two different impotence drugs, was the latest sign that drug companies are becoming as aggressive in creating and promoting consumer brands as traditional players such as Coca-Cola Co.

Consumer ads for prescription drugs long have sparked worries that they promote unnecessary spending on brand-name medicines and may mislead consumers. Now the agency says it wants to encourage clearer communication of drugs' risks. A 2002 FDA consumer survey found that 73% of respondents read little or none of the "brief summary" containing risk information in print ads.

'Less Is More'

"Less is more for consumers, because they can actually get more out of this information," said FDA Commissioner Mark McClellan.

Under the proposal unveiled Wednesday, drug companies wouldn't have to print all of the technical descriptions of risks that come from a drug's label for physicians, which often takes an entire magazine page. The new proposal urges the companies not to use "technical, scientific terms or jargon." Ads still would have to provide all of the warnings, contra-indications and major precautions, but only the three to five most common, nonserious adverse reactions. Ads also wouldn't have to include some other things, such as detailed dosage information.

The agency also wants to push drug makers to spend money on ads that educate consumers about diseases and health problems without promoting a particular product, and it issued draft guidelines about how to craft such messages.

The FDA's third proposal addresses how to advertise medical devices such as hearing aids.

The agency will seek public comment before finalizing the proposals.

Rise in Promotional Spending

The FDA's announcement is likely to spark discussion about the proper role of consumer advertising in promoting prescription drugs. Pharmaceutical spending on consumer promotion has risen, to $2.64 billion in 2002, the most recent year for which data are available, from $1.07 billion five years before, according to data from IMS Health.

Advertising executives said they favor efforts to cut down on pages of so-called mouse print. Still, these executives suggest there may be cases where marketers want to give more information, not less, particularly with medications that treat serious or life-threatening conditions. "Certain information has to be communicated, including areas like who the drug is for, who the drug is not for, minor side effects, major side effects," said Stu Klein, president of Quantum Group, a WPP Group PLC agency that specializes in health-care communications.

Other advertising executives suggest drug makers in some cases believe that providing a wealth of information has another benefit: heading off product-liability lawsuits.

Pfizer Inc., for one, said the FDA's proposals look promising, though the company said it needs to review them further. "We're supportive of any ways to get clear information about our products to consumers," says Robert Clark, Pfizer's vice president of regulatory affairs. The New York drug maker already has tried an alternative to the brief summary along the lines of the FDA proposal for Norvasc, a blood pressure medicine, he said. The plain-language patient insert cut most of the medical fine print to focus on the main benefits and risks of Norvasc. Subsequent consumer research by the company showed that patients were able to understand the information.

Challenges Are Anticipated

Advertising executives believe the FDA's push for ads that mention diseases but not treatments may run into challenges. If a manufacturer with a product that is fourth in the market launched such an initiative, the ads would benefit the entire category, including rivals, says Michael Guarini, managing director of the health-care practice at WPP's Ogilvy & Mather, an agency that has worked with clients including Merck & Co. and GlaxoSmithKline PLC. "You'll get a share of that, but obviously, the leaders will get more," he says.

The FDA's own research on direct-to-consumer ads showed both advantages and drawbacks. A survey of doctors found that in 87% of cases where a patient had asked about a drug by brand name, the patient had the condition treated by the drug. But 70% of general practitioners surveyed said that patients at least sometimes sought advertised drugs over less-expensive treatments.

The FDA has drawn questions for its recent enforcement of rules on drug advertising. A 2002 report by the General Accounting Office, Congress's investigation arm, found that a change that routed all regulatory letters that criticized drug companies' ads through the FDA's chief counsel's office "sharply reduced FDA's effectiveness in issuing...letters in a timely manner." The number of regulatory letters sent by the agency to crack down on deceptive ads also has fallen, to 24 last year from 27 in 2002 and far-higher numbers in 1999 and 2000, according to a tally released by Democratic Rep. Henry Waxman of California.

For its part, the FDA says it has focused on making sure that the regulatory letters it sends are legally sound, so they carry more impact. Moreover, the agency says, it has been channeling limited resources to some other urgent areas, including a major ramp-up of promotion enforcement against dietary-supplement makers. "Letters are not the only part of an effective enforcement strategy," Dr. McClellan said.

Posted on aef.com: February 9, 2004


Anna Wilde Mathews and Brian Steinberg, The Wall Street Journal. February 6, 2004

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