In late 2011, the FDA released a document addressing how the pharmaceutical industry can and should respond to requests about off-label drug usage. This POV provides more information about the guidance document, highlights the key issues, and offers use cases to consider in the digital realm.

1. Highlights FDA Guidance: Responding to
 The FDA has issued key requests for off-label information
considerations for Carlen Lesser, Digital Integration & Innovation
responding to unsolicited off- Contributors: Nina Baliga, Sara Collis, Rebecca Johnson and Lian Han
label requests for drug
information Summary
In late December 2011, the United States Food and Drug
Administration (FDA) released a guidance document addressing how
 In its guidance, the FDA
the pharmaceutical industry can, and should, respond to requests
outlines the difference
made about off-label drug usage. The document, titled Guidance for
between solicited and Industry Responding to Unsolicited Requests for Off-Label Information
unsolicited, public and About Prescription Drugs and Medical Devices, walks readers through
private requests for the appropriate responses. The guidance differentiates between
information unsolicited and solicited, public and private requests; cites examples
of off-label requests; and nods towards consumer and industry usage
 In general, the FDA warns that of social media tactics. In the FDA’s usual manner, the document is
all responses must provide not concrete, is not comprehensive of all situations and marketing
medical, non-promotional, mediums and is open to interpretation. However, more so than in
on-label product information previous guidance documentation, here the FDA has provided more
specific examples and “for instances.”
 The FDA emphasizes that
In general, and not surprisingly, the FDA warns that all responses,
private responses that in no
private or public, to unsolicited or solicited requests, must provide
way promote off-label use of accurate and only medically based, on-label, product information.
products are the most They also stress that responses should come from medical experts,
compliant way to respond to rather than sales representatives, and should be based on pre-
an off-label request approved language, important safety information and prescribing
information. The FDA stresses that these responses should be
 The document provides provided in private, rather than in a public forum.
guidance-specific examples
and situations that Key Information
pharmaceutical companies The FDA has carefully given its official definition of “unsolicited”:
can use to craft their "Unsolicited requests are those initiated by those persons or entities
that are completely independent of the relevant firm."(page 4, lines
response strategy
109-110). This definition is very important, as later examples in the
guidance clearly show that this also means that companies must be
 The examples refer to Web careful to in no way invite off-label requests by means of a “share
properties (both company your story” type of campaign or Web functionality. If this were to
owned and 3rd party), social happen, the requests would no longer be considered unsolicited.
networking and in-person
requests

2. The FDA states that unsolicited requests are those prompted by an entity that is “completely independent of
the relevant firm,” which includes pharmaceutical companies, medical groups, healthcare organizations and
the like, while solicited requests are those “prompted by the manufacturer or representative.“ A public
request is one made in a public forum and not necessarily directed toward the manufacturer or other medical
staff; while a private request is one made directly to the manufacturer in a public setting.
When it comes to the core issue the guidance document truly focuses on, it is fairly straight forward. Per long-
standing regulation, pharmaceutical companies still may not offer up or promote off-label uses of approved
prescription products or medical devices. This new guidance does, however, provide the industry with the
ways in which to respond to unsolicited questions about off-label uses. Where this gets interesting is that an
unsolicited request can be one that is directly sent to a pharmaceutical company or posted on a third-party
public forum. Until now, there was no legal way for a pharma company to respond on these public forums.
Public vs. Private
The definitions of public and private requests are fairly straightforward, but it is the manner in which pharma
companies respond to requests that needs to be carefully considered. In all cases, companies must ensure
that their responses in no way promote off-label use of a product. The responses, regardless of whether the
request was public or private, must be private in nature and include standard response information like the
package insert. Responses must also prominently display safety information, be scientific in nature, come
from medical personnel, and include a complete list of references for all information (page 9, lines 300-321).
A big part of the FDA’s recent guidance is an emphasis on responding to unsolicited requests through private,
one-on-one channels (page 7, lines 237-238). In an age when websites and social media platforms allow for
comments and requests via usernames, abbreviations and the like, finding the contact information necessary
to facilitate private communications may prove complex for pharmaceutical companies. Many direct
messaging features require one to be logged into the site, and would then require the approved
representative of the pharmaceutical or medical device manufacturer to have an official account on the
website in question. This opens an entirely new issue around whether or not pharma companies should have
accounts on social networking sites, or if individual representatives should create accounts used for this
purpose – an issue well beyond the scope of this document or the FDA’s guidance.
In terms of the level of effort the FDA expects from pharmaceutical companies in pursuing and seeking out the
information necessary for private communications, one can look to the FDA’s guidance in following up on
adverse event comments and messages. If the requester does not provide contact information, or is not easily
accessible through their profile, or if the platform does not permit private communications, then the
pharmaceutical company cannot respond to the request per the FDA’s recent direction. This guidance applies
to unsolicited, product-specific, off-label requests that are made either through a non-public forum or public
forum and necessitate a follow-up with off-label information.
Use Cases to Consider
While the FDA has provided many excellent examples of applications to digital, there are some additional use-
cases we believe must be considered.
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3.  Share Your Story Campaigns: The FDA does reference issues around the “share your story”
type of campaign on page 5, example 8. This example reinforces that these types of campaigns
need to continue to carefully stay within approved label indications, and whatever is posted to
the Internet in response to the “share your story” call-to-action is considered a “solicited
request.”
 On-Site Search Results: On-site search is an area that the FDA did not address, and is one that
we feel should be reviewed by individual companies in light of this guidance. It is clear from the
guidance that companies cannot publicly post off-label information on medical information
sites or any other websites. Where firms may accidentally run afoul of the guidance is in the
way search may be implemented on medical information or multi-product websites. If a user
includes a product name as part of an on-site search, the results should not include any content
that suggests an off-label use. We believe this would be considered a solicited request, and
therefore the search results are considered promotional. To avoid articles appearing that would
suggest off-label usage, firms should begin reviewing their internal search indexes and
implement negative tags that exclude possible off-label results appearing on brand-name
searches. On-site search should also clearly label whether searches are done for all the words in
the query or any word in the query. Here the issue might be that a user searches for both the
brand and an off-label use. If the search results are not properly coded, then simply returning
results could make it appear that the firm is promoting off-label use of a product.
 Frequently Asked Questions: While it may seem rational or tempting, the FDA makes it clear
that unsolicited off-label requests must be responded to only in private communications.
Because of this, no matter how frequently a question is asked, if it is off-label, it should never
be included in Frequently Asked Questions—type features.
 Newly Approved Indications: As prescription drugs go through their product lifecycles, some
drugs will see previously off-label uses become approved indications. The FDA discusses some
of the challenges online forums may represent on page 10 of the guidance, however the
recently released FDA guidance doesn’t provide specific examples or guidance on off-label
requests becoming on-label requests in the future. What the pharmaceutical industry can infer
from the FDA’s guidance is that the decision to respond to off-label, unsolicited requests and
the timing of said response rests solely with pharmaceutical companies. This means that
pharmaceutical companies are able to respond to or follow up on past off-label requests
detailing new information on that request now being on-label. For drugs that are expected to
receive multiple indications or potentially be used off-label until those indications are
approved, pharmaceutical companies should keep track of unsolicited off-label requests
because in the future these requests may become on-label and could be a key source of
communicating and selling in a drug’s new indication and use. But we recommend caution and
careful review before responding to these types of “requests.”
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4. Conclusion
All in all, this new guidance is not the groundbreaking social media guidance that some have made it
out to be. It is groundbreaking in terms of companies being able to respond to unsolicited off-label
request and does provide some additional clarity around social media engagement, but it is not
comprehensive of social media platforms, technologies and marketing strategies. As always, marketers
should firmly stick to approved indications and always provide fair balance and required safety
information along with any response. For medical information teams, this new guidance does provide
an avenue to better serve the public and answer consumers’ and healthcare professionals’ questions.
Companies should examine existing networks and Web properties to ensure they are compliant with
these recommendations. Begin by reviewing internal site search and introducing a more concise
tagging structure that will guarantee off-topic or off-label content will not show up through internal
site searches. Additionally, make sure that existing protocol for answering consumer and HCP
questions through Web channels does not link to or allude to any off-label information. Due to the
variability of individual web properties, begin your review process by consulting the Use Cases to
Consider Section above for examples of guidance compliance.
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.
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