The Impact of Direct-to-Consumer Advertising

When it comes to advertising prescription drugs on radio and television and in magazines, doctors say that, for the most part, the ads have both positive and negative effects on their patients and practices. Results of a Food and Drug Administration survey, released in 2004, also indicate that most physicians view direct-to-consumer (DTC) ads as one of many factors that affect their medical practices and their interactions with patients.

For decades, prescription drug makers promoted their products exclusively to health care professionals, who were expected to interpret drug information for their patients. Beginning in the early 1990s, some drug manufacturers began targeting consumers due, in part, to the aging baby boomers and to an increase in the number of patients participating in their own health care decisions. Since then, DTC advertising has become a popular promotional tool.

The FDA oversees the advertising of prescription drug products under the Federal Food, Drug, and Cosmetic Act and related regulations. That means the agency must ensure that prescription drug information provided by drug firms is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both health professionals and consumers.

The 500-physician survey, released in November 2004, is the third in a series of evaluations that the FDA is using to understand better how DTC prescription drug promotion affects the patient-doctor relationship.

The physician survey and two previous consumer surveys indicate that awareness of DTC ads is increasing. For example, 81 percent of consumer respondents in 2002 reported seeing or hearing an ad for a prescription drug. This figure is up from 72 percent in 1999. But 58 percent agreed strongly that DTC ads make the drugs seem better than they really are.

The results of all three surveys will help the agency decide whether advertising rules need to be changed to ensure better consumer understanding of a prescription drug's risks and benefits.

"Much of our compliance and enforcement activity is spent trying to ensure that companies don't low-ball risks in the ad and provide inflated expectations of benefit," says Janet Woodcock, M.D., deputy FDA commissioner for operations.

Other highlights of the surveys include:

Most physicians agreed that because their patient saw a DTC ad, he or she asked thoughtful questions during the visit. About the same percentage of physicians thought the ad made their patients more aware of possible treatments.
Many physicians thought that DTC ads made their patients more involved in their health care.
Physicians thought the ads did not convey information about risks and benefits equally well. Seventy-eight percent of physicians believe their patients understand the possible benefits of the drug very well or somewhat, compared to 40 percent who believe their patients understand the possible risks, and 65 percent believe DTC ads confuse patients about the relative risks and benefits of prescription drugs. In addition, about 75 percent of physicians surveyed believed that DTC ads cause patients to think that the drug works better than it does, and many physicians felt some pressure to prescribe something when patients mentioned DTC ads.
Eight percent of physicians said they felt very pressured to prescribe the specific brand-name drug when asked.
DTC ads help patients have better discussions with their physicians and provide greater awareness of treatments. The study demonstrated that when a patient asked about a specific drug, 88 percent of the time they had the condition that the drug treated. And 80 percent of physicians believed their patients understood what condition the advertised drug treats.
Doctors believe that patients understand that they need to consult a health care professional about appropriate treatment. Eighty-two percent responded either "very well" or "somewhat" when asked whether they believe that their patients understand that only a doctor can decide whether a drug is right for them.

For More Information

View the final report summarizing the three direct-to-consumer advertising surveys at
www.fda.gov/cder/ddmac/researchka.htm

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