New FDA draft guidances aim at improved risk and health information in ads and other communications
UPDATE: Feb. 5, 2004 -- The Newspaper Association of America (NAA) is supporting the FDA's draft guidelines for prescription drug advertising. The NAA said that, if implemented, the new guidelines would make print advertisements more relevant and user-friendly. "The brief summary [of a prescription drug's effects and effectiveness] need not be a lengthy recitation of numerous details about a medication that can only be understood by someone with a medical degree," said NAA President and CEO John F. Sturm. "Direct-to-consumer advertisements delivered through the newspaper provide consumers with timely and useful information in a convenient format. Allowing important health information to be communicated in a user-friendly manner, as the FDA has proposed, will greatly benefit consumers who get their news and information from newspapers."
ROCKVILLE, MD., February 4, 2004 -- The Food and Drug Administration today issued three draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. The guidances are the result of FDA research and policy development, and were influenced by public participation at an open meeting on consumer-directed advertising held by FDA in September 2003. To see information about this meeting go to www.fda.gov/cder/ddmac/DTCmeeting2003.html
"We intend to do all we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible," said FDA Commissioner, Mark B. McClellan, M.D., Ph.D. "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 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.
"And we think those discussions should reflect a better understanding of the key risks and benefits of a product."
According to an FDA study, a majority of doctors surveyed feel that DTC advertising increases patient awareness and involvement, and improves compliance. That study also shows that DTC-stimulated visits to a physician can help identify a previously undiagnosed condition. Importantly, of patients who visited their doctors because of an ad they saw, and who asked about that prescription drug by brand name, 87% actually had the condition the drug treats.
Other studies presented at the FDA open meeting also show that advertising is helpful in addressing under-treated conditions.
The draft guidances provide:
- alternatives to the lengthy, detailed, and technically-written "brief summary" of risk information for consumer-directed print advertisements for prescription drugs, with the goal of increasing consumer understanding of the key risks of the product;
- advice for manufacturers on the use of disease awareness communications, which are designed to educate patients or health care practitioners about particular diseases or health conditions, and do not promote a particular medical product, with the goal of getting more patients to discuss under-treated conditions with their doctor; and
- advice for manufacturers on compliance with federal risk disclosure rules for consumer-directed broadcast advertising for so-called "restricted" medical devices, with the goal of assuring that consumers are getting accurate information through device advertisements. (Restricted devices are the subset of FDA-regulated devices over which FDA has advertising jurisdiction. They include, for example, hearing aids, certain types of contact lenses and diagnostic tests, and many types of high-risk devices.)
Typically, manufacturers fulfill the brief summary requirement by including the complete risk related sections of the FDA-approved professional labeling in the ad verbatim, in small type. Risk information presented in this manner is designed to satisfy applicable regulations but is not user friendly.
While this risk information is technically in compliance in that it contains important information on benefits and risks, it does not convey key information effectively to many consumers. There is widespread evidence that consumers want useful information on benefits and risks in the ads that they encounter. However, although the brief summary is the main tool for conveying such information, in FDA's 1999 study, 56 percent of people who saw a consumer-directed print advertisement for a prescription drug said they read the brief summary "not at all," or "a little." In a follow-up study in 2002, that number jumped to 73 percent. During that same three-year span, those saying they read "Almost all" or "All" fell from 26% to 16%.
This draft guidance is designed to encourage manufacturers to create and deliver more user-friendly information to the public so that they can be better- informed partners in their own health care.
To support better-informed discussions between doctors and patients based on DTC advertising, FDA wants manufacturers to present key risk information in consumer-directed print advertisements in more consumer-friendly ways. The draft guidance encourages manufacturers to use clearer, less cluttered formats for presenting risk information and encourages them to focus their risk disclosures on the most important and the most common risks and to do so in language easily understood by the average consumer.
The agency believes that these alternatives may have two advantages over the traditional brief summary. Most importantly, they will be more useful for consumers, because they will communicate important information in a way that is easier for more people to understand and retain. In addition, they may reduce advertising costs, because less advertising space and complexity is required to convey the key information.
For the same reason, the draft guidance also makes clear that manufacturers can present key risk information in the main body of an advertisement by putting it in consumer-friendly bullet-point format in a "risk information window," instead of in the text.
The guidance also requests comments, research, and suggestions on additional alternatives for achieving the goal of conveying key risk information as effectively as possible in consumer-directed advertisements.
In addition to advertisements for specific medical products, so-called "help-seeking" communications can also be effective tools for disseminating information to consumers and health care practitioners about untreated and inadequately treated health conditions. This draft guidance clarifies the criteria that FDA will use to distinguish manufacturer communications that provide information about the importance of recognizing that certain signs and symptoms may be evidence of a treatable disease from manufacturer promotional messages for particular treatments for a disease.
The latter, but not the former, are subject to FDA regulation as advertising or promotional labeling. FDA hopes that, by providing clarity on the distinction between disease awareness communications and promotional materials, the agency will encourage manufacturers to provide more educational messages to the public. Because there is clear evidence that such promotion can increase treatment rates, FDA particularly encourages disease awareness communications regarding chronic and under-treated conditions.
This draft guidance includes clarifications on a related important regulatory issue: FDA has from time to time seen manufacturers use "bookend" advertisements in print or broadcast formats. These advertisements consist of two parts:
- a "reminder" advertisement, which includes the name of a drug or device but makes no safety or effectiveness claims; and
- a disease awareness message encouraging consumers to seek health care practitioner assistance in identifying and treating a particular health condition but does not mention any product by name. Neither component alone would be subject to FDA rules for requiring risk disclosure. But taken together, FDA is concerned that they are understood by consumers as product claim advertisements, without the inclusion of proper disclosure of required risk information.
The draft guidance therefore provides advice to manufacturers on the criteria FDA uses in determining whether bookend advertisements are subject to regulation as product claim advertisements. The criteria, in brief, are whether the two components are perceptually distinct and whether they are separated in space or time. FDA requests comment on these two criteria.
Draft Guidance Entitled, "Consumer-Directed Broadcast Advertising of Restricted Devices"
Some manufacturers of restricted devices have begun to promote their products directly to consumers through broadcast media. For the first tine, FDA is providing clear and specific guidance to industry on the manner in which the rules for risk disclosure apply to consumer-directed broadcast advertising for restricted devices, to help assure compliance with accurate ads that are not misleading. This guidance closely tracks analogous guidance that FDA issued for prescription drugs in 1999. Under the draft guidance, 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 means for consumers to obtain complete risk information.
"Clear, evidence-based regulatory guidance will help FDA use its limited resources to police the marketplace as effectively as possible," said Commissioner McClellan. "FDA will take action against sponsors whose ads violate the law by presenting false or misleading information to the public. Our new draft guidances are intended to help responsible companies comply, for the benefit of the public health. If they don't, we now have an even stronger basis for pursuing enforcement actions."
"Improving our nation's health literacy is a critical step in improving our nation's health," Surgeon General Richard H. Carmona, MD, said. "The FDA's new guidance will help empower more patients with accurate information that they can understand, and encourage them to ask their doctors, nurses, and pharmacists questions. By closing the gap between what doctors know and what patients understand we can begin to help Americans take better care of themselves and improve their health."
The three draft guidance documents are part of FDA's strategic plan, one goal of which is to help create better-informed consumers. To access FDA's strategic plan, go to www.fda.gov/oc/mcclellan/strategic.html.)
These DTC draft guidance documents are available online (see links below). FDA encourages public comment on these documents:
- Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements [Word] or [PDF]
- Labeling Example [Word] or [PDF]
- Labeling Example; Consumer-Friendly Version [Word] or [PDF]
- Consumer-Directed Broadcast Advertising of Restricted Devices [HTML] [PDF]
- "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms [Word] or [PDF]
Source: FDA News
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