Truth in Drug Advertising

by Food and Drug Administration (FDA)

You may have seen the advertisement: A melodrama of crime and corruption, conflict and emotion, centering on indoor hit men like dust and dander, and outdoor hit men such as pollen and ragweed, all threatening to offend a young and very beautiful woman's nose. The 45-second broadcast ad covers everything from talking to your doctor to the possible side effects that people can expect. Then the narrator mentions "Flonase."

Entertaining though it may be, the Food and Drug Administration says this promotional piece about nasal allergy relief also has all the elements of a well-crafted, easy-to-understand prescription drug advertisement directed at consumers, and it meets agency requirements for these ads.

Direct-to-consumer (DTC) advertising of prescription drugs in its varied forms — TV, radio, magazines, newspapers — is widely used throughout the United States. DTC advertising is a category of promotional information about specific drug treatments provided directly to consumers by or on behalf of drug companies. According to the U.S. General Accounting Office — the investigational arm of Congress — pharmaceutical manufacturers spent $2.7 billion on DTC advertising in 2001 alone.

The Controversy

Whether it's a 1940s, detective-style film noir of unusual allergy suspects or a middle-aged man throwing a football through a tire swing announcing that he's "back in the game," the DTC approach to advertising prescription drugs has been controversial. Some say that DTC promotion provides useful information to consumers that results in better health outcomes. Others argue that it encourages overuse of prescription drugs and use of the most costly treatments, instead of less expensive treatments that would be just as satisfactory.

There seems to be little doubt that DTC advertising can help advance the public health by encouraging more people to talk with health care professionals about health problems, particularly under-treated conditions such as high blood pressure and high cholesterol.

DTC advertising also can help remove the stigma that accompanies diseases that in the past were rarely openly discussed, such as erectile dysfunction or depression. DTC ads also can remind patients to get their prescriptions refilled and help them adhere to their medication regimens.

On the other hand, ads that are false or misleading do not advance — and may even threaten — the public health. While the FDA encourages DTC advertisements that contain accurate information, the agency also has the job of making sure that consumers are not misled or deceived by advertisements that violate the law.

"The goal here is getting truthful, non-misleading information to consumers about safe and effective therapeutic products so they can be partners in their own health care," says Peter Pitts, the FDA's associate commissioner for external relations. "Better-informed consumers are empowered to choose and use the products we regulate to improve their health."

How Ads Affect Consumers

The FDA surveyed both patients and physicians about their attitudes and experiences with DTC advertising between 1999 and 2002. The agency summarized the findings of these surveys in January 2003 in the report, Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer Promotion of Prescription Drugs.

DTC advertising appears to influence certain types of behavior. For example, the FDA surveys found that among patients who visited doctors and asked about a prescription drug by brand name because of an ad they saw, 88 percent actually had the condition the drug treats. This is important, Pitts says, because physician visits that result in earlier detection of a disease, combined with appropriate treatment, could mean that more people will live longer, healthier, more productive lives without the risk of future costly medical interventions.

With the number of ailments Patricia A. Sigler lives with — diabetes, fibromyalgia, high blood pressure, high cholesterol, nerve damage, and a heart defect called mitral valve prolapse — the 64-year-old small business owner in Jefferson, Md., says that she's always on the lookout for medicines that might improve her quality of life, and that she pays attention to DTC ads for prescription drugs.

Some Doctors Don't Agree

Michael S. Wilkes, M.D., vice dean of the medical school at the University of California, Davis, says that two reasons he doesn't like DTC advertising are that patients may withhold information from their doctors or try to treat themselves. Aiming prescription drug ads at consumers can affect the "dynamics of the patient-provider relationship," and ultimately, the patient's quality of care, Wilkes says. DTC advertising can motivate consumers to seek more information about a product or disease, but physicians need to help patients evaluate health-related information they obtain from DTC advertising, he says.

"DTC advertising may cultivate the belief among the public that there is a pill for every ill and contribute to the medicalization of trivial ailments, leading to an even more overmedicated society," Wilkes says. "Patients need to trust that I've got their best interest in mind."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.