From the FDA
"Truth in Advertising: Rx Drug Ads Come of Age
By Carol Rados
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.
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."
In three FDA surveys conducted in 1999 and 2002, physicians reported that DTC ads had these beneficial effects for patients:
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.
In the three FDA surveys, patients reported recalling this information from TV ads:
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."
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.
There has been a great deal of discussion about the brief summary that accompanies DTC print ads. The typical brief summary is not brief and uses technical language. This is because it reprints all of the risk information from the physician labeling. People have complained that the brief summary cannot be understood by consumers. Aikin says, "Patients do not typically read the brief summary in DTC print ads unless they're interested in the product." Even then, she says, much information is likely glanced at, rather than fully read.
Public input and the FDA's own experiences with DTC promotion prompted the agency to publish two new draft guidances in February 2004: one on the brief summary, and one on help-seeking ads. These guidances are designed to encourage more informative, understandable ads.
The draft guidance on the brief summary encourages companies to use consumer-friendly language and formats to convey prescription drug risk information--through a "less is more" approach. This approach focuses on the most serious and the most common risks of a drug, rather than listing every risk from the physician labeling. "Even though the information currently in the brief summary is complete, accurate, and in compliance," says Pitts, "it does not mean that patients are deriving the maximum benefit from it."
Sometimes marketers combine help-seeking ads with perceptually similar reminder ads in a way that causes the audience to perceive the two pieces as one advertisement. Appearing individually, these ads are exempted by regulation from the risk disclosure requirement. Combined, however, both ads can, in some cases, make a product-claim advertisement that requires risk disclosure.
The agency's recent draft guidance on help-seeking ads explains that help-seeking and reminder ads must appear distinct to avoid coming under the regulations for a product-claim ad. The draft guidance also addresses the separation needed between the two types of ads--in space for print ads, and in time for TV ads.
Those in Violation
For companies that don't follow the rules, DDMAC's possible actions include two types of letters--"untitled" and "warning." These letters address advertisements that make misleading claims about a drug's effectiveness--violations such as overstating the effectiveness of the drug, suggesting a broader range of indicated uses than the drug has been approved for, and lack of risk information. In both types of letters, DDMAC asks that the advertisement be withdrawn.
Warning letters, which are sent to companies that have violated the law repeatedly or that have committed serious regulatory violations in their advertising, typically request corrective advertisements to assure that the audience that received the original false or misleading information also receives truthful and accurate information.
Untitled letters are usually, but not always, sent to companies for first-time offenses or for less serious violations.
For example, the 60-second DTC broadcast television ad featuring "Digger," the well-known animated dermatophyte microorganism touting Lamisil (terbinafine), a treatment for nail fungus, was initially found to be false or misleading. The FDA sent an untitled letter to the makers of Lamisil for overstating the drug's effectiveness, minimizing its risk information, and making an unsubstantiated superiority claim. As a result, the manufacturer, Novartis Pharmaceuticals Corp., stopped running that ad.
DDMAC recently sent a warning letter to Bristol-Myers Squibb Co. about false or misleading promotional materials for Pravachol (pravastatin sodium), a drug approved to lower cholesterol in people with high cholesterol, to help prevent heart attacks in people with high cholesterol or heart disease, and to help prevent stroke in people with heart disease. One of the company's ads misleadingly suggested that the drug had been proven to help prevent stroke in all people worried about having a stroke, regardless of whether or not they had heart disease.
Another ad, directed at diabetes patients, misleadingly suggested that Pravachol had been proven to help prevent heart attacks and stroke in people with diabetes. Following the warning letter, the company created a corrective ad campaign acknowledging that Pravachol had not been approved for these indications.
Assessing DTC advertising is an ongoing process for the FDA. As more research surfaces, the agency will continue to evaluate DTC drug promotion and will take additional measures as appropriate to protect the public health.
DTC Ads at a Glance
mention a drug by name
make representations about the drug, such as its safety and effectiveness
must have fair balance of information about effectiveness and risks
are required to disclose risks in a "brief summary" of benefits and risks (for print ads)
are required to give a "major statement" of risks and "adequate provision" for finding out more, such as a toll-free number (for broadcast ads).
provide the name of the medication
may provide other minimal information, such as cost and dosage form
do not make a representation about the drug, such as the drug's use, effectiveness, or safety
are not required to provide risk information.
educate consumers about a disease or medical condition
let people know that treatments exist for a medical condition
don't name a specific drug
are not required to provide risk information."