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Criteria for Advertisements Directed to Physicians and Other Health Care Professionals

Chapter:
Ethical and Legal Considerations
Author(s):

Annette Flanagin

Criteria for Advertisements Directed to Physicians and Other Health Care Professionals

The editorial and publishing staff of JAMA and the Archives Journals have developed general eligibility requirements and guidelines for advertising copy to ensure that advertisements published in these journals are appropriate (see Tables 1 and 2).4 The ASME also has developed a guide for print-based advertisements.3

Table 2. Guidelines for Advertising Copy in Journals Published by the American Medical Association (AMA)

  1. 1. The advertisement should clearly identify the advertiser of the product or services offered. In the case of drug advertisements, the full generic name of each active ingredient shall appear. [This requirement applies to print ads; for online ads, the active ingredient may appear on the company or manufacturer’s website to which the ad links.]

  2. 2. Layout, artwork, and format shall be such as to be readily distinguishable from editorial content and to avoid confusion with the editorial content of the publication. The word Advertisement may be required.

  3. 3. Unfair comparisons or unwarranted disparagements of a competitor’s products or services will not be allowed.

  4. 4. Advertisements will not be acceptable if they conflict with the Principles of Medical Ethics of the American Medical Association or the advertising guidelines in Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association.

  5. 5. It is the responsibility of the manufacturer to comply with the laws and regulations applicable to marketing and sale of its products. Acceptance of advertising in AMA publications should not be construed as a guarantee that the manufacturer complies with such laws and regulations.

  6. 6. Advertisements may not be deceptive or misleading.

  7. 7. Advertisements will not be accepted if they are offensive in either text or artwork, or contain attacks of a personal, racial, sexual, or religious nature, or are demeaning or discriminating toward an individual or group on the basis of age, sex, race, ethnicity, religion, physical appearance, or disability.

 

The following criteria for print pharmaceutical ads are adapted from the guidelines prepared by the World Health Organization17 and the International Federation of Pharmaceutical Manufacturers Associations14:

  1. 1. Advertising text should be presented legibly.

  2. 2. Pharmaceutical ads in print journals must include the following (in online ads, this information may be included on a website to which the ad links):

    • Name of the product, typically the trade (brand) name

    • The active ingredients, using either the international nonproprietary names or the approved generic name of the drug

    • Name and address of the manufacturer or distributor

    • Date of production of the advertisement

    • Abbreviated prescribing information, which should include an approved indication or indications for use together with the dosage and method of use and a succinct statement of the contraindications, precautions, and adverse effects

    • For a “reminder” advertisement (a “short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product”5), the abbreviated prescribing information may be omitted. (See also 5.12.3, Advertorials.)

  3. 3. When published studies are cited in promotional material, standard retrievable references with complete bibliographic information should be included (see also 3.0, References). Information in advertisements and other promotional material, such as excerpts from the medical literature or quotations from personal communications, must not change or distort the intended meaning of the author(s) or the significance of the relevant work or study. Prepublication peer review and editorial evaluation of articles help to reduce problems associated with misleading or inappropriate information from published articles, but ads do not typically undergo the same level of evaluation before publication. Several studies have documented problems with advertisements in medical journals, including promotional statements not being accurately supported by references, references cited to support promotional statements that are not retrievable (eg, “data on file”), and numerical distortion of data presented in tables and graphs.18-22Thus, some editors have instituted formal review processes to assess the validity of claims made in ads.23,24

  4. 4. According to the International Federation of Pharmaceutical Manufacturers Associations,14 the same requirements that apply to printed materials should also apply to electronic promotional materials, including audiovisuals. Specifically, in the case of pharmaceutical product-related websites, the identity of the pharmaceutical company and of the intended audience should be readily apparent, the content and presentation should be appropriate for the intended audience, and country-specific information should comply with local laws and regulations.14 (See also 5.12.6, Advertising and Sponsorship in Online Publications.) Typically, an online advertisement links to a company’s website, where the details about the prescribing information as listed above are provided.

Five issues should be addressed in any journal’s policy on advertising:

  1. 1. Advertising-to-editorial content ratio

  2. 2. Advertising interspersion

  3. 3. Advertising-editorial juxtaposition (adjacency)

  4. 4. Editorial calendars

  5. 5. Appropriate advertising content

Advertising-to-Editorial Content Ratio.

For print publications that have an abundance of advertising, setting an ad-editorial page ratio (ie, limiting the advertising content to no more than a certain proportion of total annual pages) may help protect the perceived integrity of the publication.25 The ICMJE recommends that journals not be dominated by advertising and that they avoid publishing advertisements from only 1 or 2 advertisers; otherwise readers may perceive that the journal is sponsored by 1 or 2 advertisers and that these advertisers have influenced the editor and the editorial content.2 For print journals, compliance with relevant postal regulations in some countries may also need to be considered if the number of ad pages exceeds the number of editorial pages. The ratio of editorial to advertising on Web versions of journals should also follow these general principles.

Advertising Interspersion.

Placing advertisements between articles and interleaving them within articles may attract advertisers, but such practices may also diminish the perceived credibility of the publication—especially if the ads create difficulty for the reader in reading or finding editorial content.2,25 For scholarly biomedical journals, ads should not be interleaved within a scientific or clinical article in print or online. Many print publications group, or stack, their ads in the front and back of their journals, leaving an editorial “well” in the middle of the publication for major articles that are not interspersed with ads. Stacking ads can cause some advertisers to go elsewhere because they want their ads to be placed next to editorial material. For that reason, some journals place popular editorial features (such as news articles) in the front and back of the journal to allow for ad interspersion of those sections and maintain an ad-free editorial well for the original research and other major articles. Ads should not appear on the journal’s front cover. For discussion of advertising interspersion on the Web, see also 5.12.6, Advertising and Sponsorship in Online Publications.

Advertising-Editorial Juxtaposition (Adjacency).

Advertisers may request placement of their ads next to related editorial content to help promote their products. Although common in consumer publishing, this practice is discouraged by the ICMJE and the ASME.2,3 Ad adjacency, like ad interspersion, may be an impediment to readers and may diminish the perceived integrity of a scholarly publication.2,10 To avoid the occurrence of adjacent ads and editorial content on the same topic, even by chance, the editorial staff of JAMA and the Archives Journals review the entire makeup (imposition) of the journal after the ad deadlines have closed and before the journal is printed. If an ad is scheduled to appear adjacent to an article on the same or a closely related topic, the editors ask the production staff to move the ad or may decide to move the article. For those journals that permit online ads on pages with editorial content, ad adjacency policies should be developed that maintain the journal’s editorial integrity. (See also 5.12.6, Advertising and Sponsorship in Online Publications, for additional discussion of advertising-editorial adjacency in online publications.)

Editorial Calendars.

Providing advertising sales representatives with editorial calendars that include specific content scheduled for upcoming issues invites pressure for advertising-editorial adjacency and other attempts from industry to interfere with editorial decisions. The ICMJE states that advertising should not be sold on the condition that it will appear in the same issue as a particular article.2 Journal editors and publishers can respond to industry pressure by reminding advertisers of the importance of the journal’s integrity. Advertisers understand this issue, because without integrity, a publication will have few readers, and without readers, the advertiser cannot sell products. For this reason, advertising sales staff should not have access to the journal contents until after publication. However, sales staff may know about general editorial plans, such as plans for theme issues, proceedings, symposia, or sponsored supplements (see 5.12.4, Sponsored Supplements).

Appropriate Advertising Content.

Appropriate ads must meet the following requirements4,13,16,17,26:

  • No false claims

  • No implied false claims

  • Ability to substantiate claims

  • No omissions of important facts

  • No distortion of data

  • Good taste (although this is difficult to define objectively)

  • Clear identification of the advertiser of the product or services being offered

  • Layout, artwork, and format that differ from those of the editorial content so that readers can clearly distinguish the advertising and editorial content

Biomedical journals typically publish a disclaimer statement to separate the claims made by advertisers from the views of the journals’ owners. For example, the following statement appears in each issue of JAMA:

ADVERTISING PRINCIPLES—Advertisements in this issue have been reviewed to comply with the principles governing advertising in JAMA and the Archives Journals. A copy of these principles is available on request and online at www.jama.com. The appearance of advertising in JAMA is not an AMA guarantee or endorsement of the product or the claims made for the product by the manufacturer.

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