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.

1. FDA Warning: Fair Balance Applies to
Highlights Website Copy and Navigation
 Dr. Reddy’s Laboratories’ Dr. Reddy’s Laboratories’ Fondaparinux Sodium Solution
Fondaparinux Sodium Solution HCP Website
Lian Han and Sara Collis, Digital Integration and Innovation
HCP website received an FDA
January 2012
warning 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 Solution
prominence in displaying the HCP website. The website was cited for failing to prominently
boxed warning in the website’s display the boxed warning in both the copy and navigation. The
copy 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 that
is consistent with previous FDA
pharmaceutical marketers should now consider.
guidances, the comments
regarding 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 the
should be careful in naming boxed warning prominently within the copy, 2) not including the
navigation elements, links and boxed warning in the primary navigation, and 3) an overall effect
buttons, and as always ensure of imbalance on the website.
that boxed warnings and
Important Safety Information are In more detail, the FDA cited Dr. Reddy’s for the following:
prominently displayed and
follow 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. 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/War
ningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM285967.pdf
For insights into applying FDA regulations to digital marketing, visit: http://rtcrm.com/whitepapers.
RTCRM Proprietary Page 2

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 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.
RTCRM Proprietary Page 3