FDA Warning: Fair Balance Applies to Website Copy and Navigation Dr. Reddy’s Laboratories’ Fondaparinux Sodium Solution HCP Website Lian Han and Sara Collis, Digital Integration and Innovation January 2012

Summary On December 22, 2011, the FDA released a warning letter regarding Dr. Reddy’s Laboratories’ Fondaparinux Sodium Solution HCP website. The website was cited for failing to prominently display the boxed warning in both the copy and navigation. The letter supports the FDA’s continued mandate that pharmaceutical websites display safety information with the same visual weight as any benefit claims. It also demonstrates that the FDA considers navigation to be part of the fair balance equation—something that pharmaceutical marketers should now consider. Key Information The FDA cited three major issues with the Fondaparinux Sodium Solution HCP website. The issues cited are: 1) not placing the boxed warning prominently within the copy, 2) not including the boxed warning in the primary navigation, and 3) an overall effect of imbalance on the website. In more detail, the FDA cited Dr. Reddy’s for the following: Lack of Boxed Warning in Copy: Typically black box pharmaceutical drugs should present safety information with visual prominence and preferably above the fold. The Dr. Reddy’s website fails to do this—the boxed warning is relegated to the bottom of the page, below other patient and drug information. The net effect of this low page placement is a lessened emphasis on the most important section of the safety information.

Lack of Boxed Warning in Navigation: The primary navigation includes all sections of the Prescribing Information (PI) and Important Safety Information (ISI), except for the boxed warning. The FDA has pointed out that separating the PI and black box information is misleading, and by doing so the website has failed

Highlights

Dr. Reddy’s Laboratories’ Fondaparinux Sodium Solution HCP website received an FDA warning letter on December 22, 2011. The letter cited lack of prominence in displaying the boxed warning in the website’s copy and navigation. While the concern about copy is consistent with previous FDA guidances, the comments regarding navigation are unique.

Pharmaceutical marketers should be careful in naming navigation elements, links and buttons, and as always ensure that boxed warnings and Important Safety Information are prominently displayed and follow fair balance guidelines.

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to accurately provide users with balanced access to the black box information.

Overall Effect: The FDA states that by hiding the boxed warning at the bottom of the page and by not including it in the primary navigation, the “overall effect of this presentation undermines the communication of the boxed warning.”

Implications and Action Items As detailed in the RTCRM whitepaper New Transparency and New Trust (Lesser, 2009), translating PI into website content is acceptable as long as the overall effect of benefit versus safety information is balanced. This warning letter confirms the FDA’s stance that any component of the website, whether navigation, video, copy or other, is included in this overall effect. More specifically, the FDA is stating that the boxed warning should have primary real estate within these components in order to effectively maintain fair balance. As a result, pharmaceutical marketers should consider the following when designing Web properties: Safety Information in Copy: ISI should be visible to the user and prominently displayed with the same visual weight as any benefit claims. This includes placement on the page, font, text size, color and imagery. ISI should appear as an integrated part of the Web content, and there should not be a visual stopping point prior to the ISI. The boxed warning should be prominently displayed with other safety information and in a way that does not diminish the importance of this warning compared to other material, copy and content on the page. Ideally the boxed warning has priority real estate and should often be mentioned at the top of a webpage, at the top of the ISI and in any ISI links and navigational labels.

Safety Information in Navigation and Buttons: When determining what content to include in the primary navigation of any website, pharmaceutical marketers should be sure to balance any efficacy information with safety information. The boxed warning should be included in this consideration—if, for example, the greatest benefit of the drug is mentioned in a button in the primary navigation, then the boxed warning should also have its own button in the navigation. Furthermore, RTCRM suggests calling out the the boxed warning in the utility navigation (the links at the top of a website) where one often finds other links to important safety information, in order to maintain balance of information. RTCRM also suggests a consistent footer navigation that can direct users to the boxed warning and safety information. To view this FDA Warning Letter, visit: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM285967.pdf For insights into applying FDA regulations to digital marketing, visit: http://rtcrm.com/whitepapers.

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About the Digital Integration and Innovation Team The RTCRM Digital Integration and Innovation team is tasked with keeping track and making sense of the ever-changing digital world. It’s our job to understand the nuances of how and why different types of people use technology and what

that tells us about them. More importantly, it’s our job to help our clients apply this knowledge to better communicate with their customers. We help clients translate business goals into marketing campaigns that build relationships with customers. In the 21st century, understanding how and why someone uses technology is as important as understanding where they live, what gender they are and how old they are. That’s where we come in. From ensuring that digital behavior is considered in the research phase, to tactical plans that align digital, print and broadcast tactics, we work with clients and internal partners to make sure it all works. It’s not about what’s cool. It’s about what works. About RTCRM RTC Relationship Marketing (RTCRM) is a full-service direct marketing and relationship marketing agency based in Washington, D.C., in the heart of Georgetown, with an additional office in New York. RTCRM boasts more than 40 years’ worth of innovative, targeted solutions that grow its clients’ brands and help them forge lasting, valuable relationships with their customers. What distinguishes RTCRM is its unique ability to analyze data and research on both a rational and emotional level. RTCRM’s clients include major brands in the telecom, technology, pharmaceutical, and other business sectors such as AARP, BlackRock, Eli Lilly, and Novo Nordisk. To learn more about RTCRM, please visit www.rtcrm.com or follow the Twitter feed @rtcrm.