Author: Stacy LukasavitzSocial Media Strategist

June, 2010

Social Media Guidelines and Safeguards for the Pharmaceutical Industry:

What You Need to Know (For Now)

Facebook Privacy:

Implications for Marketers

June, 2010

PREPARED BY

Stacy LukasavitzSocial Media Strategist

stacy.lukasavit@mslworldwide.com

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 1health and medical information . 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.

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.

Marketers should not be responsible for content online that is not under their control or

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.

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

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,

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 2advertisements . The FDA has subsequently stated that it “never had what some are referring

3to as a ‘one-click’ rule.”

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.

Accountability

Transparency and Regulatory Requirements

Facebook Privacy:

Implications for Marketers

June, 2010

PREPARED BY

Stacy LukasavitzSocial Media Strategist

stacy.lukasavit@mslworldwide.com

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.

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).

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 4the site . 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.

It is still unresolved as to whether incomplete adverse event reports (e.g. anonymous postings)

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.

Corrective Information

Adverse Event Reporting

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.

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,

http://www.fdasm.com/docs/FINAL%20DDMAC%20Responses%20to%20FDASM_Questions.pdf

4. FDA, Post-Approval Safety Data Management: Definitions and Standards for Expediting

Reporting, ICH Harmonized Tripartite Guideline Draft (July 18, 2003), available at

http://www.fda.gov/RegulatoryInformation/Guidances/ucm129457.htm