Direct-to-Consumer Drug Advertising

llergies. Asthma. Depression. Diabetes. Hair loss. Impotence. It's hard to pick up a magazine or watch TV these days without being bombarded by ads touting the wonders (and worries) of some new prescription drug for a particular disease or medical condition.

Direct-to-consumer (DTC) advertising, as it's called in the trade, is big business and projected to get even bigger. Last year drug companies spent $1.3 billion on DTC ads; this year it's projected to be closer to $2 billion, according to Brett Kay of the National Consumers League (NCL), Washington, D.C.

   The broadcast ads—
   TV and radio spots—
   always must disclose
   a product's
   major risks.

Misconceptions
about drugs
could lead consumers
to avoid treatment
or choose not to
continue medication.

Safer, quicker, better?
With American consumers getting more involved in their own health care, proponents claim these ads help educate the public about medical problems and possible solutions. DTC opponents fear the ads will drive up drug prices and encourage consumers to ask doctors for inappropriate or unnecessary prescriptions.

Although the ads have been around for more than 15 years, they didn't become prevalent until the early 1990s, according to Nancy Ostrove, with the Food and Drug Administration's (FDA) division of drug marketing, advertising, and communications. Drug companies stepped up their advertising after the FDA eased DTC advertising regulations in 1997. Before then, companies that didn't want to include details of a drug's risks—along with its benefits—in TV and radio ads were more likely to opt for "reminder ads" or "help-seeking ads."

According to the FDA, reminder ads call attention to a drug's name without stating the condition it's used to treat. Help-seeking ads tell consumers about treatment available for a condition and direct them to talk to a health-care professional. While these ads do not name a drug, they can disclose the name of a manufacturer. With ads like these giving only part of the picture, consumers and health-care professionals were confused.

The new draft guidance, issued by the FDA in August 1997, describes how prescription drug companies can use broadcast advertisements to promote a product directly to consumers, including the product's use, without scrolling the type of detailed risk information that appears in magazine and other print ads. FDA regulations require that ads only may make claims supported by scientific evidence, that are not inconsistent with the FDA-approved product labeling, and are not false or misleading. FDA regulations also call for "fair balance" in every ad, meaning a manufacturer clearly must disclose both risks and benefits.

The broadcast ads—TV and radio spots—always must disclose the product's major risks in either the audio and/or visual parts of the ad; this is sometimes called the "major statement." Under the Federal Food, Drug, and Cosmetic Act, prescription drug ads must contain "information in brief summary relating to side effects, contraindications, and effectiveness." However, critics say these summaries are written for doctors in language not easily understood by consumers.

"Major risk information must be stated in the ads, but, in addition, instead of including all the risks, they can instead have a mechanism through which people can get full product labeling," says Ostrove. While the FDA always has allowed this "adequate provision" for broadcast ads, it had not described what options ads could use to ensure they'd meet FDA standards.

Under the new guidelines, such an ad would contain: a toll-free number for consumers to call to obtain the approved package labeling by mail, fax, or prerecorded telephone message; a reference to print ads for the product running in consumer magazines, or the availability of brochures containing package labeling in such public places as libraries, pharmacies, grocery stores, or doctors' offices; a statement directing consumers to talk to their doctor or pharmacist; and an Internet Web address where product labeling information is posted.

What consumers think
The NCL held a conference on DTC ads in September with representatives from the government, consumer groups, advertising agencies, drug companies, and pharmacists. Kay says that as a result of the conference, the NCL conducted a random sample phone survey and a mall intercept survey asking respondents about personal health habits, the sources they use to obtain health-related information, and their exposure and reaction to a variety of DTC ads.

Some 80% of respondents said they'd seen or heard prescription drug ads, and 68% thought they increased their consumer knowledge. According to Kay, nearly half of the respondents had talked to their doctor about a drug, and 25% said it helped them talk to their doctor about a disease. Of those seeking prescriptions for a specific drug, 22% said the doctor prescribed it. Another 12% said their doctor indicated the drug wasn't appropriate for them, but 5% said they received prescriptions for alternate drugs.

The survey results indicate that regardless of the format, "The DTC ads were pretty similar in conveying the message, and that people were taking home information about risks and benefits," says Kay. Regardless of the message or format, Kay says respondents often had preconceived notions about a drug's side effects or contraindications—such as don't take if you're pregnant or are younger than age 18—when the warnings weren't indicated in the ads. While Kay thinks this is a good indication that consumers are cautious, it could also lead them to avoid treatment or choose not to continue medication because of misconceptions.

"There is a clear message that ads have a fair balance and that both the benefits and risks are conveyed clearly and equally," Kay says. He adds that survey results also indicate that the ads' summaries need to be reworked in a more consumer-friendly format. "Type fonts need to be larger, clearer, and [summaries] described in laymen's terms," says Kay.

Ostrove agrees: "Sometimes manufacturers simply take the package labeling and reprint it in their ads. Lay people don't have the knowledge to understand this information." Ostrove says the FDA encourages manufacturers to rewrite the brief summary information in consumer-friendly language, and that the agency is starting to see more-understandable summaries.

What consumers need out of DTC ads, says Kay, is good, clear information that is in context—that a drug may not be right for them, and that all medicines have risks—and, ideally, that the benefits outweigh the risks.

Kay says, "Sometimes drugs are the best treatment course; other times it's better to do natural things first, like diet and exercise, before medication treatment." But with everyone looking for that magic bullet, it's often hard for health-care professionals to get people to take self-directed preventive measures first. "Consumers need to take more control of their health care," Kay says. "They need to be actively involved, eating well, talking to doctors, and checking out information and options."

     Direct-to-consumer
     advertising critics
     fear ads will
     drive up prices and
     encourage consumers      to ask doctors for      inappropriate      prescriptions.