FDA Public Hearing Promotion FDA Public Hearing Promotion of FDA-Regulated Medical Products Using the Internet November 12, 2009 Testimony of Interactive Advertising Bureau David G. Adams Venable LLP

2 IAB Trade association of media and technology companies who sell online advertising Trade association of media and technology companies who sell online advertising 375 companies 375 companies Search engines such as Google and Yahoo! Search engines such as Google and Yahoo! Major newspapers and broadcast networks Major newspapers and broadcast networks Health information websites such as Waterfront Media and Lifetime Health information websites such as Waterfront Media and Lifetime

3 IAB Standards Standard-setting organization for advertising on the Internet Standard-setting organization for advertising on the Internet IAB members provide 85% of online advertising in the U.S. IAB members provide 85% of online advertising in the U.S. Standards and guidance in many areas Standards and guidance in many areas Universal Ad Package Universal Ad Package General formats General formats Online Behavioral Advertising Principles Online Behavioral Advertising Principles Format and content for notices Format and content for notices

4 Overview Internet as an interactive medium Internet as an interactive medium FDA policies regarding promotion FDA policies regarding promotion Importance of standardization Importance of standardization IAB standardization process IAB standardization process

5 Internet as a Unique Medium FDA must consider unique character of Internet FDA must consider unique character of Internet Value of the medium Value of the medium How it is used How it is used Practical limitations inherent to the medium Practical limitations inherent to the medium Importance of including FDA-regulated information in the healthcare dialog Importance of including FDA-regulated information in the healthcare dialog

6 User Interaction Interactive Interactive User control – point and click User control – point and click Ease of movement to specific information Ease of movement to specific information Links Links Different from and superior to print and broadcast references to other sources of information Different from and superior to print and broadcast references to other sources of information Linkage to Package Insert or Brief Summary Linkage to Package Insert or Brief Summary Linkage to information required for fair balance Linkage to information required for fair balance Content Expansions Content Expansions Pop-up, scroll, change in content or dimensions Pop-up, scroll, change in content or dimensions

7 Standardization of Presentation Standardization is important for optimal use and consumer understanding Standardization is important for optimal use and consumer understanding Assist consumers in finding and accessing the types of information required by law and by FDA policy Assist consumers in finding and accessing the types of information required by law and by FDA policy Especially risk information Especially risk information Goal would be optimal formats for providing information Goal would be optimal formats for providing information Information that consumers want and need Information that consumers want and need Information meeting FDA regulatory requirements Information meeting FDA regulatory requirements

8 Standards as Safe Harbors Importance of interaction with FDA regarding industry advertising standards Importance of interaction with FDA regarding industry advertising standards Application of traditional rules to Internet unclear Application of traditional rules to Internet unclear Uncertainty is bad for all parties Uncertainty is bad for all parties FDA needs to take creative approaches and provide workable guidance FDA needs to take creative approaches and provide workable guidance Beneficial to have industry standards that provide mechanisms for meeting FDA standards Beneficial to have industry standards that provide mechanisms for meeting FDA standards

9 IAB Process IAB is not proposing standards today IAB is not proposing standards today IAB members here today discussing ideas and proposals IAB members here today discussing ideas and proposals IAB is initiating a process to draft standards IAB is initiating a process to draft standards Formats for sponsored links, banner ads, and video presentations Formats for sponsored links, banner ads, and video presentations Use of links and content expansion mechanisms (pop-ups, scrolls, etc.) Use of links and content expansion mechanisms (pop-ups, scrolls, etc.) Process Process Participation by advertisers and advertising agencies Participation by advertisers and advertising agencies Public comment on draft proposals Public comment on draft proposals Collaboration with FDA Collaboration with FDA

10 IAB Objectives IAB hopes that FDA will find IABs standardization effort useful in the agencys policy-making process IAB hopes that FDA will find IABs standardization effort useful in the agencys policy-making process IAB hopes to work with FDA IAB hopes to work with FDA To better enable consumers to access and use FDA-regulated information and To better enable consumers to access and use FDA-regulated information and To develop standards that will help assure advertisers that they are meeting FDA requirements To develop standards that will help assure advertisers that they are meeting FDA requirements