This is a POV I wrote in June 2010 advising pharmaceutical companies on what they should do in the social media space until the FDA issues its official guidelines. It will soon be updated.

1. Social Media Guidelines and Safeguards
for the Pharmaceutical Industry:
What You Need to Know (For Now)
Author: Stacy Lukasavitz
Social Media Strategist
June, 2010

2. Social Media Guidelines and Safeguards for the
Pharmaceutical Industry: What You Need to Know (For Now)
Various business sectors have embraced the new communication channels of social media as a
valuable means for marketing and disseminating information. The FDA-regulated
pharmaceutical industry has been slow to adapt to these ever-changing technologies and has
yet to fully embrace and adopt official policies or guidelines.
Since 1996, the FDA has expressed interest in developing an official position on internet
marketing and promotion but has continued to delay the process. In November 2009, the FDA
held a public hearing and solicited written comments through a public docket that was open
from September 2009 to February 2010 with the intention of issuing a guidance document in
2010 on social media and the promotion of prescription products.
Trends in internet usage suggest this issue cannot be ignored in the meantime. It is reported
that in 2008, more than 60 million consumers used social media to communicate and research
health and medical information1. There is a lot of information and misinformation about
pharmaceutical products online, and the industry has more questions than answers right now
on how to address issues concerning them. This paper serves to address some of these
concerns and advise on appropriate actions to take online until the FDA issues its official
position and guidelines.
Accountability
Marketers are responsible for any communications they create, collaborate on, or cause to be
created. This includes online communications paid for by, or performed on behalf of, the
manufacturer. For example, a video on YouTube created by a media agency for Drug X should
be treated as directly attributable to the manufacturer, despite involvement of the media
company.
Facebook Privacy:
Marketers should not be responsible for content online that is not under their control or
Implications for Marketers
influence, such as discussions on third-party, unrelated forums. However, if a manufacturer
owns a social media site, such as a discussion forum for diabetics that is owned by a
manufacturer of diabetes management supplies, it is their responsibility to monitor and correct
misinformation and adverse effects on their domain.
Transparency and Regulatory Requirements June, 2010
In addition to all sites hosted or financially affiliated with the manufacturer, there should be a
statement of sponsorship and/or disclosure on all social media properties associated with the
manufacturer. It should be the company’s responsibility to ensure that such disclosures are in
place and accurate, and if a social media site’s content is commonly viewed through other
applications or platforms, such as TweetDeck, Tweetie, or Hootsuite, the disclosure must also
be visible on those platforms.
To include fair balance, Important Safety Information should be included alongside any
branded message. However, in the instance of space-constrained social tools, the “one-click”
rule should be put into place – ensuring that Important Safety Information should be AT MOST
one click away from any branded message.
It should be noted that although the industry had developed the “one-click” rule as a way to
PREPARED BY
comply with the FDA’s requirement to provide comprehensive product information (including
safety information) in promotional material, and it was accepted by the FDA as satisfactory,
Stacy Lukasavitz
the rule was suddenly placed into question when the FDA issued enforcement letters to 14
companies in 2009 for their failure to include risk information in Google banner
advertisements2. The FDA has subsequently stated that it “never Social Mediaare referring
had what some Strategist
to as a ‘one-click’ rule.”3 stacy.lukasavit@mslworldwide.com
Because of the FDA’s sudden switch on position in this matter, having “one-click” links to
important product and safety information should be approached with caution. However, it is
expected that the FDA will go back to accepting this as satisfactory when it issues its official
guidelines later this year.

3. In addition, company representatives (or representatives of company subsidiaries and
affiliates) should always identify their relationship to the company whenever participating in an
online forum accessible to the public. This includes forums such as message boards,
chat rooms, blog and news comments, etc. In the case of a threaded discussion or other
instances where the entirety of a discussion is not visible on a single page, such identification
should be in each instance they sign or make a claim.
Corrective Information
Companies are not responsible for information created by third parties and available on
genuinely independent third-party sites (that is, sites that the manufacturer has not created,
cannot control, and does not fund).
Wikipedia provides the clearest illustration. For many pharmaceutical products, the Wikipedia
entry is likely to be among the sources of information most accessed by consumers. Most
content on Wikipedia can be changed at any time, by anyone. A company may reasonably
choose to monitor relevant Wikipedia entries, but cannot be fairly held accountable for the
content. However, if content is inaccurate, a manufacturer may post corrective information on
the third-party site, but in doing so must be transparent, non-misleading, and compliant with
existing requirements (such as for risk communications).
Adverse Event Reporting
Prior FDA guidance on adverse event reporting states that manufacturers should review any
internet sites they sponsor for adverse experience information, and they are responsible for
reviewing third-party sites only when they become aware of a potentially reportable issue on
the site4. But until FDA takes a position on adverse events reported through social media, this
guidance does not necessarily apply to social media.
That said, the FDA might require manufacturers to actively monitor all social media sites for
adverse events. However, due to the breadth and growth of the internet, it is simply not
possible to do so. It will more likely require companies to actively monitor only websites they
control or influence.
Facebook Privacy:
It is still unresolved as to whether incomplete adverse event reports (e.g. anonymous postings)
Implications for Marketers
should be pursued, and whether certain social media is even appropriate context for the
industry to investigate potential adverse events.
Until the FDA has issued its decision on what, where, when, or how to investigate and report
adverse event reports, nothing is mandatory. But monitoring of company-controlled or
influenced sites early is highly encouraged. June, 2010
1. Manhattan Research, Cybercitizen Health v8.0, The State of eHealth: Trends of Today’s
eHealth Consumer, at 203 (2008), available at
http://www.ahdionline.org/ca/ahdi-wa/news/articles/The_State_of_eHealth.pdf.
2. See
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Enforce
mentActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompani
es/UCM143487.pdf.
PREPARED BY
3. FDA Response to Ignite Health FDA Social Media, Questions for the FDA Regarding ‘Next
Steps’ for Guidance Related to the Promotion of FDA-Regulated Medical Products Using the
Internet and Social Media Tools, Dec. 11, 2009, Stacy Lukasavitz
http://www.fdasm.com/docs/FINAL%20DDMAC%20Responses%20to%20FDASM_Questions.pdf
Social Media Strategist
4. FDA, Post-Approval Safety Data Management:stacy.lukasavit@mslworldwide.com
Definitions and Standards for Expediting
Reporting, ICH Harmonized Tripartite Guideline Draft (July 18, 2003), available at
http://www.fda.gov/RegulatoryInformation/Guidances/ucm129457.htm