FDA Warning Letters: Dr. Reddy's Labs, January 2012

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The FDA recently released a warning letter to Dr. Reddy’s Laboratories’ for the HCP site for their product Fondaparinux. The website was cited for failing to prominently display the boxed warning in both the copy and navigation. This POV, from RTC's Digital Integration and Innovation team, gives more background on the FDA warning and discusses the implications for drug companies and marketers.

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FDA Warning Letters: Dr. Reddy's Labs, January 2012

  1. 1. FDA Warning: Fair Balance Applies toHighlights Website Copy and Navigation Dr. Reddy’s Laboratories’ Dr. Reddy’s Laboratories’ Fondaparinux Sodium SolutionFondaparinux Sodium Solution HCP Website Lian Han and Sara Collis, Digital Integration and InnovationHCP website received an FDA January 2012warning letter on December 22,2011. Summary On December 22, 2011, the FDA released a warning letter The letter cited lack of regarding Dr. Reddy’s Laboratories’ Fondaparinux Sodium Solutionprominence in displaying the HCP website. The website was cited for failing to prominentlyboxed warning in the website’s display the boxed warning in both the copy and navigation. Thecopy and navigation. letter supports the FDA’s continued mandate that pharmaceutical websites display safety information with the same visual weight as While the concern about copy any benefit claims. It also demonstrates that the FDA considers navigation to be part of the fair balance equation—something thatis consistent with previous FDA pharmaceutical marketers should now consider.guidances, the commentsregarding navigation are unique. Key Information The FDA cited three major issues with the Fondaparinux Sodium Pharmaceutical marketers Solution HCP website. The issues cited are: 1) not placing theshould be careful in naming boxed warning prominently within the copy, 2) not including thenavigation elements, links and boxed warning in the primary navigation, and 3) an overall effectbuttons, and as always ensure of imbalance on the website.that boxed warnings andImportant Safety Information are In more detail, the FDA cited Dr. Reddy’s for the following:prominently displayed andfollow fair balance guidelines. 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
  2. 2. 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 notincluding it in the primary navigation, the “overall effect of this presentation undermines thecommunication of the boxed warning.”Implications and Action ItemsAs detailed in the RTCRM whitepaper New Transparency and New Trust (Lesser, 2009), translating PIinto website content is acceptable as long as the overall effect of benefit versus safety information isbalanced. This warning letter confirms the FDA’s stance that any component of the website, whethernavigation, video, copy or other, is included in this overall effect. More specifically, the FDA is statingthat the boxed warning should have primary real estate within these components in order toeffectively 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 thesame visual weight as any benefit claims. This includes placement on the page, font, text size, colorand imagery. ISI should appear as an integrated part of the Web content, and there should not be avisual stopping point prior to the ISI. The boxed warning should be prominently displayed with othersafety information and in a way that does not diminish the importance of this warning compared toother material, copy and content on the page. Ideally the boxed warning has priority real estate andshould often be mentioned at the top of a webpage, at the top of the ISI and in any ISI links andnavigational labels.Safety Information in Navigation and Buttons: When determining what content to include in theprimary navigation of any website, pharmaceutical marketers should be sure to balance any efficacyinformation 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, thenthe boxed warning should also have its own button in the navigation. Furthermore, RTCRM suggestscalling out the the boxed warning in the utility navigation (the links at the top of a website) where oneoften 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 andsafety information.To view this FDA Warning Letter, visit:www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM285967.pdfFor insights into applying FDA regulations to digital marketing, visit: http://rtcrm.com/whitepapers. RTCRM Proprietary Page 2
  3. 3. 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 whatthat tells us about them. More importantly, it’s our job to help our clients apply this knowledge tobetter communicate with their customers. We help clients translate business goals into marketingcampaigns that build relationships with customers. In the 21st century, understanding how and whysomeone uses technology is as important as understanding where they live, what gender they are andhow old they are. That’s where we come in. From ensuring that digital behavior is considered in theresearch phase, to tactical plans that align digital, print and broadcast tactics, we work with clients andinternal partners to make sure it all works.It’s not about what’s cool. It’s about what works.About RTCRMRTC Relationship Marketing (RTCRM) is a full-service direct marketing and relationship marketingagency 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’ brandsand help them forge lasting, valuable relationships with their customers. What distinguishes RTCRM isits unique ability to analyze data and research on both a rational and emotional level. RTCRM’s clientsinclude major brands in the telecom, technology, pharmaceutical, and other business sectors such asAARP, BlackRock, Eli Lilly, and Novo Nordisk.To learn more about RTCRM, please visit www.rtcrm.com or follow the Twitter feed @rtcrm. RTCRM Proprietary Page 3

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