Comments of the Interactive Advertising Bureau on Internet and Social Media Promotion of FDA-Regulated Medical Products. Docket No.

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1 Comments of the Interactive Advertising Bureau on Internet and Social Media Promotion of FDA-Regulated Medical Products I. Introduction Docket No. FDA-2009-N-0441 February 26, 2010 The Interactive Advertising Bureau (the IAB ) appreciates the opportunity to submit these written Comments in response to the U.S. Food and Drug Administration s ( FDA ) Notice of Public Hearing and Request for Comments ( FDA Notice ) on issues related to the promotion of FDA-regulated medical products. 1 The IAB was pleased to participate in the FDA s public hearing on this topic, held on November 12-13, 2009, and offers these Comments for the record. Founded in 1996, the IAB ( represents over 375 leading companies that engage in and support the sale of interactive advertising, including leading search engines, online publishers, and health information websites. Collectively, our members are responsible for selling over 85% of online advertising in the United States. The IAB educates policymakers, marketers, agencies, media companies and the wider business community about the value of interactive advertising. Working with our member companies, the IAB evaluates and recommends standards and practices and fields critical research on interactive advertising. The IAB is committed to promoting best practices in interactive advertising. II. Summary of Comments Online advertising is a vast, complex, and evolving business ecosystem. Although online advertising is similar to marketing in other media, there are important distinctions. Unlike other types of advertising, online messages can be presented effectively within strict space limitations because of interactive technologies that allow consumers to access more information instantly. However, the Internet s unique technological capabilities have raised new issues regarding the application of the FDA s existing regulatory principles on medical products promotion. In the wake of recent FDA enforcement notices, medical products companies may be reluctant to engage in online advertising given the lack of clarity, thereby depriving consumers of relevant and critical health information that can improve and even save lives. The IAB believes that consumers and industry would benefit from consistent standards on the online promotion of FDA-regulated medical products. The IAB further 1 74 Fed. Reg. 48,083 (Sept. 21, 2009). 1

2 believes that industry developed standards are particularly effective in promoting compliance in the rapidly evolving high-tech arena because such standards are flexible enough to respond to ever changing technology. The IAB intends to work with its members in developing standards in this area, drawing on its expertise in developing similar standards from other areas of online advertising. As this effort moves forward, the IAB would welcome the opportunity to consult with the FDA in developing standards that satisfy existing principles for the promotion of FDA-regulated medical products. III. Today s Online Advertising Ecosystem A. Online Advertising Is Complex and Thriving Internet advertising is no longer a novel or little-used practice, but a critical mainstream avenue for businesses to communicate with consumers about relevant products and services. As a result of this expansion and the unique technical attributes of the Internet, online advertising has become a vast and complex business ecosystem. The IAB estimates that there are nearly one million websites that sell advertising, and that these websites delivered 4.5 trillion online advertisements to consumers in The major forms of Internet advertising today include: Sponsored links retrieved by search engines; Classified and directory listings; and Display advertising, including Animated or static images, sometimes displayed in banner format, Digital video displayed in screens on a webpage, and Rich media (interactive multimedia). Internet advertising is a thriving sector of the American economy. According to a recent study entitled The Economic Value of the Advertising-Supported Internet Ecosystem, conducted for IAB by Harvard Business School Professors John Quelch and John Deighton, e-commerce and online advertising contribute $300 billion each year to the U.S. economy and employ 3.1 million Americans. Internet advertising produced $10.9 billion in revenues for the first half of 2009 alone. Search advertising accounted for almost half of this amount, with display advertising as the next largest category. Online advertising practices continue to evolve rapidly as advertisers take advantage of new technologies and formats. B. Online Advertising Uses Interactive Features within Space Constraints Online advertising is distinguished from offline advertising by its space constraints and interactive nature. Because online display advertising generally appears next to website content, there is little opportunity for full-page advertisements such as those found in print media. Display advertising typically must fit into standardized 2

3 spaces with very small dimensions. For sponsored links, search engines generally permit a title line of 25 characters, two lines of text with 35 characters per line, and a display link of up to 35 characters. Social networking sites also impose length restrictions. For example, Facebook has limits of 25 characters for the title and 135 characters for the body of an advertisement, and Twitter posts (or tweets ) are limited to 140 characters each shorter than many sentences. While it would appear that such space constraint would be ineffective or limiting in promoting goods or services, Internet advertising is effective within these space constraints because of the interactive nature of online media. There are numerous common interactive features that allow Internet users to expand available information or seek new information from just a few words that appear in an advertisement. Such ability was not possible in the print advertising found in magazines and newspapers that were the primary form of advertising when the FDA s existing standards were developed. In an era of high-speed Internet connections, such additional information appears virtually instantly and without limits. Common interactive features include linked text or graphics, back and forward browser buttons, expandable text boxes, and scroll bars. Internet users are familiar with these types of interactive features and are adept at navigating them rapidly. The success of Internet advertising shows that when providing information online, it is not necessary to present all information to the consumer in the first level of a display to be effective in conveying important information as long as consumers can easily locate more details by interacting with the display. Indeed, the Federal Trade Commission ( FTC ), in issuing staff guidance to advertisers on how to present clear and conspicuous disclosures for online advertising, recognizes that hyperlinked disclosures are appropriate under some circumstances. 2 The FTC has provided advertisers with detailed suggestions on how to format such disclosures so that they will be seen and read by consumers. This ability to present large amounts of information effectively from an initial short disclosure or link, by exploiting the interactive features of the Internet, distinguishes online communications from traditional media. IV. Development of Consistent Standards for Online Promotion of FDA- Regulated Medical Products Would Benefit Public Health In 2009, the FDA s Division of Drug Marketing, Advertising and Communications sent Notice of Violation ( NOV ) letters to several companies asserting that certain sponsored links for pharmaceutical products misbranded the drugs in violation of law. 3 Since the issuance of these letters, there has been some degree of uncertainty regarding the requirements for advertising pharmaceuticals online. Many pharmaceutical companies have not fully embraced online advertising, with the 2 Federal Trade Commission, Dot Com Disclosures: Information about Online Advertising (May 2000). 3 See, e.g., Shefali Doshi, FDA Division of Drug Marketing, Advertising, and Communications, Letter to Fadwa Almanaky, Bayer Healthcare Pharmaceuticals, Inc. (undated). 3

4 unfortunate consequence that consumers have less access to information about prescription drugs that may benefit them. With more than 157 million American adults seeking health information online, 4 this outcome is detrimental to public health, as these people would benefit from receiving full and fair information about relevant products. FDA regulations on the promotion of medical products have already been adapted to different media settings such as television and radio. It is imperative to bring the same level of certainty to the online arena, so that industry may achieve compliance and embrace through online advertising the limitless amount of information that can be made available to consumers. The IAB believes that such certainty can be achieved through industry standards that adapt the principles of existing FDA regulations to the online context. Such standards should be both effective and workable in light of evolving technologies. V. The IAB Will Seek to Launch the Development of Industry Standards for Internet and Social Media Promotion of Medical Products The IAB strongly believes that industry developed standards provide the best means to protect consumers in the fast-changing Internet advertising ecosystem. Such standards provide a robust yet flexible framework that can respond quickly to changes in business practices. Effective standards can also conserve government enforcement resources. Industry standards enable legitimate businesses to demonstrate compliance with agency expectations, so that government can focus on pursuing businesses that engage in bad conduct. Legitimate businesses have a strong incentive to enforce such standards in order to foster the consumer trust on which online commerce depends. The IAB has extensive experience in developing strong industry standards through an open process that incorporates public comments as well as advertiser participation. The IAB draws on industry expertise to promulgate standards that are technically feasible in the complex setting of online advertising. IAB standards have been issued and widely adopted for many aspects of Internet advertising. For example, IAB s Universal Ad Package dictating consistent sizing is followed by an estimated 73% of online advertisements. Drawing on this prior experience, the IAB is seeking to launch an effort to develop standards that are specific to online promotion of FDA-regulated medical products and address the questions set forth in the FDA s Notice. The adoption of such standards by IAB members would protect consumers by creating consistency and providing clear guidance to advertisers. The IAB s goal is to design comprehensive standards that adapt the FDA s existing requirements for medical products promotion to the online advertising context. The IAB would welcome the opportunity to consult with the FDA on this important effort. 4 Manhattan Research: Cybercitizen Health v

5 The IAB thanks the FDA for the opportunity to participate in its workshop and to provide comments. Please contact Mike Zaneis at (202) for further information. 5