FDA issues guidance on drug company advertising

Survey reveals physicians’ perspective

Stung by criticism that it is not doing enough to enforce its own regulations governing direct-to-consumer advertising by pharmaceutical companies and medical device manufacturers, the U.S. Food and Drug Administration (FDA) announced the publication of three new guidance documents designed to improve communications the public sees about new drugs and devices.

"We intend to do all that we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible," FDA commissioner Mark B. McClellan, MD, said in a Feb. 4 statement announcing the new guidelines. "Our new regulatory guidance provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence on what works and what doesn’t in drug promotion."

The guidance documents were largely the result of a September 2003 open meeting on direct-to-consumer advertising held by the FDA.

Such advertising has long been a concern of health care providers and public health advocates because of the potential to influence consumers to seek treatments they may not need or that may not be appropriate.

A 1999 survey by the American Medical Association (AMA) found that half of all consumers believe the FDA preapproves drug ads and 43% incorrectly believe that only risk-free drugs are advertised.

"The AMA supports patients’ increased access to drug information, but questions whether direct-to-consumer drug advertising, designed to sell a product, provides the objective and accurate information that patients need," Nancy H. Nielsen, MD, PhD, said in a July 2003 testimony before the Senate Special Committee on Aging.

The AMA recommended to Congress that the pharmaceutical industry be required to use AMA guidelines for ads to improve their educational value; that independent research on the ads is needed to determine their impact on the physician-patient relationship and on health outcomes and costs; and that more funding be allocated to FDA efforts to oversee direct-to-consumer advertising.

However, the FDA reported that a nationwide survey of physicians indicated that most felt that drug advertising aided the physician-patient relationship by encouraging patients to seek screening for conditions that might otherwise go unnoticed and discuss their health concerns with their physicians.

"The evidence shows that promotions directed to consumers can play an especially important role in helping patients start a discussion with their health care practitioner about conditions that are often unrecognized and therefore undertreated, such as diabetes, high blood pressure, high cholesterol, and depression," McClellan said.

According to the survey, a majority of physicians felt that direct-to-consumer advertising increased patient awareness and involvement and improved compliance. The study also showed that the advertising-stimulated visits to a physician could help identify a previously undiagnosed condition.

Of patients who visited their physicians because of an ad they saw and who asked about that prescription drug by brand name, 87% actually had the condition the drug treated.

The FDA issued three different guidance documents covering key areas of potential confusion for consumers viewing advertising and information about new drugs and devices:

  • "Brief summaries" of risk information in print advertisements. The first guidance covers information contained in print advertisements that is intended to disclose information about the potential risks of taking the advertised drug. The FDA requires a brief summary of the product’s risks and most companies fulfill this requirement by reprinting, verbatim, the complete risk-related sections of the FDA-approved professional labeling. The information typically is located in a box at the bottom of the ad in very small type.

    However, says McClellan, the labeling information often contains complex clinical and technical language that does not effectively convey key information to patients.

    In the FDA survey, 56% of people who saw a consumer-directed print advertisement stated that they did not read the summary statement and, in a follow-up study, that number jumped to 73%.

    The draft guidance is designed to help manufacturers create more user-friendly brief summaries to include in the ads.

    The FDA now wants manufacturers to present key risk information in a more consumer-friendly fashion by using clearer, less-cluttered formats, focusing the disclosures on the most important and most common risks, and using language that can easily be understood by the average consumer.

  • "Help-seeking" communications vs. advertisements. The second document covers the "help-seeking" or "disease awareness" communications that some manufacturers produce that provide general information about recognizing signs and symptoms of a particular condition, but that do not advertise a specific product or treatment for it.

    Advertisements are subject to FDA regulation as advertising or promotional labeling, but true "help-seeking" communications are not. The second document provides clarification to companies about the distinction between disease awareness communications and advertising.

  • Broadcast advertising of restricted devices. Some manufacturers of restricted devices also have begun advertising their products directly to consumers through the broadcast media, McClellan notes.

    The third document provides explicit guidance to industry on how its regulations for risk disclosure apply to broadcast advertising, and to help assure that the ads are accurate and not misleading.

    A manufacturer of a restricted device may satisfy the statutory requirement for risk information disclosure by presenting a major statement of product risks and by identifying alternative sources of the complete risk information.

"Clear, evidence-based regulatory guidance will help the FDA use its limited resources to police the marketplace as effectively as possible," McClellan said. "FDA will take action against sponsors whose ads violate the law by presenting false or misleading information to the public."

The guidance documents are available on the FDA web site at www.fda.gov.


  • U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857-0001.