Truth in Drug Advertising : Education or Promotion?

by Food and Drug Administration (FDA)

(Page 2 of 3)

Others who favor DTC ads say that consumer-directed information can be an important educational tool in a time when more patients want to be involved in their own health care. Carol Salzman, M.D., Ph.D., an internist in Chevy Chase, Md., emphasizes, however, that physicians still need to remain in control of prescribing medications.

"Doctors shouldn't feel threatened by their patients asking for a medicine by name," she says, "but at the same time, patients shouldn't come in expecting that a drug will be dispensed just because they asked for it."

Salzman says she finds it time-consuming "trying to talk people out of something they have their hearts set on." Wilkes agrees. Discussions motivated by ads that focus on specific drugs or trivial complaints, he says, could take time away from subjects such as a patient's symptoms, the range of available treatments, and specific details about a patient's illness.

Education or Promotion?

At least one patient advocacy group is concerned about what it says are the downsides of advertising prescription drugs directly to consumers, claiming that DTC ads often masquerade as educational tools, but provide more promotion than education. The ads, they say, provide little access to unbiased information.

"People need to be careful with ads that it isn't just hype that they're going to feel better, with no objectivity of the downsides," says Linda Golodner, president of the National Consumers League in Washington, D.C. Although all DTC advertisements must disclose risk information, she says what is typically communicated is a brand name, a reason to use the product, and an impression of the product. Golodner wants all offices within the FDA that have a responsibility for any aspect of DTC advertising to work together. "There's a lot of the same information out there, so why not bring it all together so that consumers can understand it better?"

Truth in Advertising

The FDA has regulated the advertising of prescription drugs since 1962, under the Federal Food, Drug, and Cosmetic Act and related regulations. The regulations establish detailed requirements for ad content. Most other advertising, including that of over-the-counter drugs, is regulated by the Federal Trade Commission under a different set of rules.

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) oversees two types of promotion for prescription drugs: promotional labeling and advertising. Advertising includes commercial messages broadcast on television or radio, communicated over the telephone, or printed in magazines and newspapers. Prescription drug ads must contain information in a "brief summary" relating to both risks and benefits. Recognizing the time constraints of broadcast ads, FDA regulations provide that a broadcast advertisement may include, instead of a brief summary, information relating to the major risks. The ad must also make "adequate provision" for distributing the FDA-approved labeling in connection with the broadcast ad. This refers to the concept of providing ways for consumers to find more complete information about the drug.

Most ads fulfill this requirement by including a toll-free telephone number, a Web site address, or a link to a concurrently running print ad. They also encourage consumers to talk to their health care providers. Both print and broadcast ads directed at consumers may only make claims that are supported by scientific evidence.

DDMAC oversight helps ensure that pharmaceutical companies accurately communicate the benefits and risks of an advertised drug. The regulations require that advertising for prescription drugs must disclose certain information about the product's uses and risks.

In addition, advertisements cannot be false or misleading and cannot omit material facts. FDA regulations also call for "fair balance" in every product-claim ad. This means that the risks and benefits must be presented with comparable scope, depth, and detail, and that information relating to the product's effectiveness must be fairly balanced by risk information.

The FDA does not generally require prior approval of DTC ads, although companies are required to submit their ads to the FDA at the time they begin running. The agency, therefore, routinely examines these commercials and published DTC ads after they become available to the public. FDA, however, also is happy to review proposed ads if a drug company makes a request.

"We look at a lot of DTC ads before they run," says Kathryn J. Aikin, Ph.D., a social scientist in DDMAC. "Manufacturers typically want to be sure they're getting started on the right foot."

The Trouble With Ads

Of the three types of DTC advertisements, the first and most common — product-claim ads — mention a drug's name and the condition it is intended to treat, and describe the risks and benefits associated with taking the drug. Some manufacturers have decided not to present this much information and instead, have made use of two other kinds of ads. "Reminder" ads give only the name of the product, but not what it is used for, and "help-seeking" ads contain information about a disease, but do not mention a specific drug. These help-seeking — or disease-awareness — ads can be extremely informative and, because they name no drug, they are not regulated by the FDA. Examples of help-seeking ads are those that mention high cholesterol or diabetes, and then direct you to ask your doctor about treatments. Reminder ads call attention to a drug's name, but say nothing about the condition it is used to treat, its effectiveness, or safety information. A reminder ad is not required to include risk information.

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.