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For years, pages of indecipherable “medicalese” have accompanied prescription drug advertising in magazines and newspapers. Known as the “brief summary,” the descriptions were neither brief nor summary. On Feb. 4, the Food and Drug Administration issued a draft guidance for improvement, called “Brief Summary”: Disclosing Risk Information in Consumer-Directed Print Advertisements. The draft guidance represents an important first step toward making direct-to-consumer prescription drug print promotions more useful and informative for their intended audience. But more work is still needed. When the FDA approves a prescription drug for marketing, the drug’s “professional labeling” is an essential part of that approval. The professional labeling includes detailed chemical information, a scientific and statistical description of the drug’s demonstrated effectiveness and safety, and a recitation of adverse reactions, warnings, and contraindications. This highly technical document is intended to guide the health care professional in how to safely and effectively prescribe the drug. A BIT LESS PROFESSIONAL The professional labeling is closely tied to the FDA’s regulation of prescription drug advertising. The Federal Food, Drug and Cosmetic Act requires that most prescription drug advertisements bear information “in brief summary relating to [the drug's] side effects, contraindications, and effectiveness.” By regulation, the FDA linked this brief summary requirement to the professional labeling. For print advertisements, the brief summary must present each specific side effect and contraindication from the advertised drug’s FDA-approved professional labeling. The FDA promulgated the brief summary requirements at a time when manufacturers primarily promoted their prescription drugs through medical journal advertisements. Typically, drug manufacturers complied with the brief summary requirement by placing an advertisement on one page of a periodical, and on an adjoining page (or pages), re-printing much of the drug’s professional labeling. For advertising directed to health care professionals, this approach makes good sense. By including a drug’s professional labeling with its advertising, a physician or pharmacist has sufficient information to prescribe and dispense the drug safely and effectively. The benefit of including the professional labeling with print advertisements in publications directed to consumers is more dubious. The “look” of these brief summary reprints is certainly familiar. An advertisement appears on one page of TV Guide or Time; an adjoining half or full page is crammed with barely legible medical jargon. While this type of brief summary technically complies with FDA requirements, it plainly fails to communicate the risks and benefits of the advertised prescription drug in a manner that is useful to the consumer. Consumer advocates, industry, medical professionals, newspaper and magazine publishers, and governmental agencies repeatedly have argued that the brief summary in direct-to-consumer print advertising was incomprehensible to consumers. Even the FDA’s own data repeatedly showed that most consumers did not read the brief summary. The need for reform of the brief summary requirement has been one of the few issues on which the FDA and every other interest group in the prescription drug promotion debate have agreed. With the issuance of the draft guidance, the FDA signaled it was placing consumer comprehension ahead of technical compliance. In the words of FDA Commissioner Mark McClellan, the FDA is taking a “less is more” approach to the brief summary. In its press release announcing the draft guidance, the FDA urges manufacturers to use “clearer, less cluttered formats for presenting risk information” and to focus on the advertised drug’s most important and most common risks “in language easily understood by the average consumer.” Simpler brief summaries, the FDA states, will be more useful for consumers and reduce advertising costs. BRIEFER AND BETTER In the draft guidance, the FDA sets out the three circumstances where it does not intend to object to the brief summary for a direct-to-consumer print advertisement: • A brief summary may present all risk information from the FDA-approved professional labeling. • A brief summary may reproduce FDA-approved “patient” labeling (a shortened version of the professional labeling, written during the drug approval process for patients), either in its entirety or as modified to omit less important risk information. • A brief summary may incorporate the risk information from a “Highlights” box that would set forth concisely the information necessary for medical professionals to safely and effectively prescribe the drug (the “Highlights” box derives from a proposed rule to revise the format for professional labeling that the FDA has not yet finalized). Regardless of which of the above labeling vehicles is used, the brief summary must include: • All contraindications; • All warnings; • The major precautions, including any that describe serious adverse drug experiences or steps to be taken to avoid such experiences; and • The most common nonserious adverse reactions most likely to affect the patient’s quality of life or compliance with drug therapy. The FDA encourages presenting this information in consumer-friendly language and format. This simplified brief summary may state that the information is not complete, and provide a toll-free telephone number or Web site address where consumers can obtain additional information. The draft guidance includes a one-page example of the new brief summary. The example demonstrates that prescription drug risk information can be presented concisely and in an accessible format that consumers are more likely to understand. The draft guidance is a positive step away from the medicalese that has dominated print direct-to-consumer promotion for many years. The FDA’s emphasis on consumer comprehension, and its acknowledgement that not every adverse reaction need be in the brief summary, are significant improvements. The FDA also encourages experimentation with different formats, such as “facts” boxes (like the “Nutrition Facts” for foods) and “risk information windows” as alternatives to, or in conjunction with, a separate brief summary. The agency also solicits research assessing what is most useful for consumers to ensure that they receive understandable risk information that will help them make well-informed decisions. Even so, a number of outstanding questions and concerns remain. One challenge offered by the draft guidance is that the brief summary must include all contraindications; all warnings, major precautions, steps to avoid such events; and the most common nonserious adverse reactions. The challenge will be to convey all this information in plain language, without using too many words or too much space. In comments to the FDA, the Federal Trade Commission and others urged resolution of the brief summary problems by extending the FDA’s broadcast standards to print advertising. Under the broadcast approach, an advertiser may omit the brief summary if it includes a major statement of the risks associated with drug, and makes “adequate provision” for the consumer to obtain additional information from other accessible sources, such as the Internet, print publications, and a toll-free number. The draft guidance does not implement this approach, and instead continues to require that print advertising include an accompanying brief summary. The broadcast “adequate provision” recommendation deserves further evaluation, particularly if consumer research demonstrates that the alternative brief summary formats that the FDA proposes do not improve consumer comprehension of risk information. MAKING IT CONSISTENT Another issue of concern is that the draft guidance only applies to traditional “advertising” such as would appear in magazines and newspapers. Under longstanding FDA interpretations, direct-to-patient communications such as brochures in doctors’ offices and pharmacy newsletters are “labeling” that “accompanies” the drug, rather than “advertising.” Any promotional “labeling” must include the drug’s full, professional labeling, even though it is directed to and intended for consumers. The FDA will need to address this anomaly to avoid undermining the goals the draft guidance is intended to foster. The draft guidance also does not distinguish promotional messages from other types of communications. Pharmacies, for instance, frequently distribute messages to their customers, reminding them to complete the full course of their medicine or to refill their prescriptions. The draft guidance would treat these types of pharmacy communications the same way it would traditional direct-to-consumer promotion — the brief summary, or even the full professional labeling, would have to accompany them. Where a pharmacy communication is merely furthering compliance with an already prescribed therapy, it makes sense to exempt these messages from the requirements applicable to direct-to-consumer promotions altogether. Last, there is an ambiguity about what to do when there is no “Highlights” box or patient labeling to use. That is, the new brief summary formats that the draft guidance proposes all derive from FDA-approved documents: the professional labeling, the patient labeling, or the “Highlights” box. Therefore, the draft guidance could be read as suggesting that, where neither patient labeling nor a “Highlights” box is available, only the professional labeling will satisfy the FDA’s brief summary requirements. Instead, the FDA should make clear that it intends to implement a more consumer-friendly reading of the draft guidance: in the absence of a “Highlights” box or patient labeling, the FDA will encourage companies to write concise and effective brief summaries that are based upon the professional labeling, but do not repeat its risk information verbatim. In sum, the FDA is to be commended for issuing a draft guidance that recognizes what the agency’s own data have long reported — the traditional brief summary does not work for consumers. The draft guidance encourages innovation and places consumer comprehension ahead of technical compliance with legal requirements. But more can be done. The FDA is accepting comments on the draft guidance until May 10, and will issue a final guidance based upon its review of the comments. With some further refinements, the FDA will truly help consumers understand print promotions. Richard L. Frank is a founder and a senior principal of Olsson, Frank and Weeda, in Washington, D.C., a firm that specializes in food, drug, medical device, and agricultural law. Tish E. Pahl is a senior associate in the firm’s food and drug practice. They can be reached at [email protected] and [email protected], respectively.

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