Download Nothing Ventured, Nothing Gained?: Benefits, Risks and Best

In-House Plenary Session: A Look at How Technology Issues Impact Our
Clients
Nothing Ventured, Nothing
Gained?:
Benefits, Risks and Best
Practices for Pharmaceutical
Companies Considering
Expanding Their Social Media
Presence
Moderator: Lori B. Leskin
Kaye Scholer LLP
New York, NY
Larissa A. Eustice
Kaye Scholer LLP
New York, NY
1
Introduction
In November 2013, it was estimated that 800 million unique users visit Facebook per month, 250
million users visit Twitter, and 200 million users visit LinkedIn.1 Every day, an increasing
number of physicians and patients turn to the Internet and social media sources to access health
information. This explosion of interactive, collaborative Web 2.0 sites2 provides pharmaceutical
companies with a unique opportunity to use these mediums to convey up-to-date scientific data
about medical conditions and FDA-approved medications. Pharmaceutical companies’ in-house
counsel and their marketing departments need to better understand social media and how to best
leverage these mediums to convey important health and safety information to patients and
consumers.
At the same time, although there are numerous benefits of engaging consumers and patients
online, social media marketing also poses unique challenges for an industry as closely regulated
as pharmaceuticals. Despite repeated requests for industry-wide guidance or comprehensive new
regulations, the FDA has largely left unanswered the question of how pharmaceutical companies
can safely engage with social media. As a result, pharmaceutical manufacturers and in-house
counsel are left to guess at what constitutes appropriate use. Until the FDA issues its policy
regarding the use of the Internet and social media for promotion of FDA-regulated medical
products, which it has promised by July 9, 2014,3 pharmaceutical companies must decide how to
engage in rapidly growing social media outlets.
This article reviews the growing presence of social media in medical fields and summarizes the
FDA’s limited social media guidance. This article also identifies the benefits and risks inherent
to social media advertising and provides in-house pharmaceutical counsel with “best practices”
for engaging with online and social media advertising.
While not exhaustive, the
recommendations below should help in-house counsel and their marketing departments navigate
social media while attempting to reduce regulatory exposure until final FDA input is issued.
The Internet as a Primary Source of Health Information
Online medical sources, including resources like WebMD.com and patient community forums
such as PatientsLikeMe.com, are increasingly the first place patients turn for health information
and are an important source for patient education. Results from a national consumer survey
conducted by Makovsky Health and Kelton reveal that the average U.S. consumer spends 52
hours annually researching health information on the Internet, but only visits a doctor three times
a year.4 The survey also found that WebMD is the most commonly accessed online source for
1
eBizMBA, Top 15 Most Popular Social Networking Sites, available at http://www.ebizmba.com/articles/socialnetworking-websites (last visited Nov. 26, 2013).
2
A Web 2.0 site may allow users to interact and collaborate with each other in a social medial dialogue as creators of
user-generated content in a virtual community, in contrast to websites where people are limited to the passive viewing
of content. Examples of Web 2.0 sites include social networking sites, blogs, wikis, video sharing sites, hosted
services, and web applications. See Wikipedia, Web 2.0, available at http://en.wikipedia.org/wiki/Web_2.0 (last visited
Dec. 11, 2013).
3
See 21 U.S.C. § 379d-5 - Guidance document regarding product promotion using the Internet: “Not later than 2 years
after July 9, 2012, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug
Administration policy regarding the promotion, using the Internet (including social media), of medical products that are
regulated by such Administration.”
4
Makovsky Health, Online Health Research Eclipsing Patient-Doctor Conversations, (Sept. 9, 2013), available at
http://www.makovsky.com/insights/articles/25-insights/articles/article/229-as-the-web-goes-mobile-healthcare-standsstill (last visited Nov. 25, 2013).
2
healthcare information and that almost a fourth of consumers (24%) use at least one or a
combination of social media sources -- including YouTube, Facebook, blogs and Twitter feeds -to seek healthcare information.5 The survey, fielded to 1,067 nationally representative Americans
aged 18 and older, also revealed that “the majority of Americans would visit pharma-sponsored
websites after receiving a diagnosis (51%),” while “23% would access this resource before filling
a prescription and 16% after first experiencing symptoms.”6 Another study conducted by the Pew
Internet Project estimates that between 75% and 80% of Internet users have looked online for
health information, while 31% of “e-patients” interviewed stated that they or someone they know
has been significantly helped by following medical advice or health information found on the
Internet.7
Despite the increasing tendency of patients and consumers to seek out health information using
online sources, the pharmaceutical industry has been relatively slow to take advantage of these
mediums. This reluctance stems in part from the lack of clear regulations governing a
pharmaceutical company’s use of online and social medial promotions.
Because the
pharmaceutical industry is so heavily regulated, and violation of accepted promotional practices
may have costly (both financial and reputational) repercussions, pharmaceutical companies have
“tended to wait for the FDA to establish explicit codes of acceptable marketing practices before
devoting substantial resources to a new medium.”8 Thus, while every Big Pharma company has
at least some presence on social platforms, these websites, for the most part, do not currently
contain product promotions. However, as laid out more fully below, pharmaceutical companies
may risk falling behind and losing touch with consumers and patients if they wait for FDA
regulations before more fully engaging in social media and Internet communications.
Dearth of Regulatory Guidance
As early as 1996, the FDA engaged in a limited discussion of the issues related to the promotion
of FDA-regulated medical products on the Internet.9 Following this early public hearing,
however, the FDA did not release any social media policies or formally revisit the issue until
2009. Recognizing the growth of social media and its adoption by consumers and marketers, in
late 2009, the FDA again sought public input regarding the use of the Internet and social media to
promote prescription drug products. Two years later, in December 2011, the FDA published
narrow draft guidance on “responding to unsolicited requests for off-label information about
prescription drugs and medical devices.”10
While a step in the right direction, the 2011 guidance only addressed how companies should reply
to online requests about off-label uses of their products. The guidance does not respond to the
myriad questions and concerns posed by the pharmaceutical industry, perhaps best encapsulated
by Pfizer’s open letter11 to the FDA, which was submitted shortly after the public hearing in
5
Id.
6
Id.
7
P. Gupta & A. Udupa, Social Media Marketing by Pharmaceutical Industry: Perception and Attitudes of Key
Stakeholders, BUS. & ECON. J., 2011 Annual, at BEJ-20, citing S. Fox, The engaged e-patient population, 2008 Pew
Internet and American Life Project, available at http://www.pewinternet.org/Reports/2008/The-Engaged-EpatientPopulation/The-Engaged-E-patient-Population.aspx (last visited Nov. 20, 2013).
8
Jeremy A. Greene & Aaron S. Kesselheim, Pharmaceutical Marketing and the New Social Media, 363 NEW ENG. J.
MED. 2087, 2087 (2010).
9
See Promotion of FDA-Regulated Products on the Internet, 61 Fed. Reg. 48,707 (Sept. 16, 1996).
10
See Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs
and
Devices,
(Dec.
2011),
available
at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf.
11
See “Comments of Pfizer Inc on the Use of the Internet and Social Media in Promoting FDA-Regulated Medical
Products,” (Docket No. FDA-2009-N-0441), submitted to the FDA on February 26, 2010. Shortly after the public
3
February 2010. Neither does it offer any clear instructions to the industry about how it can
leverage social media to convey important health information about its products. A final
limitation stems from the fact that the FDA issued draft guidance, not new regulations. Given the
unique context of social media -- which differs in many important respects from traditional media
-- new regulations, not merely an interpretive gloss on existing rules, are needed to define the
parameters of use and to advise pharmaceutical companies as to what steps they must take to
appropriately engage with consumers via the Internet and social media.
Faced with uncertainty as to whether existing drug advertising regulations will continue to be
applied to social media outlets, or whether the FDA will develop platform-specific rules that take
into account the realities of social media, pharmaceutical companies have been reluctant to
engage. But “in this new age of participatory medicine” where “patients are increasingly
harnessing the internet to gain knowledge about health conditions,”12 the cautious adoption of
social media by pharmaceutical manufacturers may be unwise. If they wait, pharmaceutical
manufacturers risk losing critical opportunities to communicate directly with patients and
consumers, to participate in building disease-awareness, to generate valuable relationships with
patient communities, and to respond to physician, patient and community needs.13
Benefits, Risks and Best Practices for Pharmaceutical Companies
Not only has social media been adopted by a huge portion of the population worldwide, but many
companies outside of the pharmaceutical industry have leveraged social media to advertise their
products and communicate with customers. Using social media, companies can more effectively
connect with customers, join and build communities, collect research data, advertise products,
and engage online customers in dialogs about the company and its products. Applied to
pharmaceutical companies, social media presents an unrivaled opportunity to provide legitimate,
scientific medical information about drugs and medical conditions and to solicit consumer
(physician and patient) input. Because the “integration of social media into medical care has
hearing held on November 12-13, 2010, Pfizer submitted its comments to the FDA calling for “clear, enforceable,
evidence-based regulatory requirements that reflect real-world user expectations in the Internet and social media [ . . . ]
to encourage manufacturers to provide truthful and non-misleading product information, subject to FDA regulatory
oversight, to improve the overall quality of health information available to users online.” Pfizer called specifically for
new regulations, not guidelines which it noted would be unable “to change existing rules.” Pfizer’s letter identified
several “guiding principles” that it believed “should inform FDA’s development of a regulatory paradigm.” Key
among these principles was that “product communications in the Internet and social media contexts must be truthful
and non-misleading, and the specific regulatory techniques that FDA employs to achieve that objective must be
evidence based.”
Pfizer made explicit that it believed that the “FDA should not try to fit the square peg of Internet and social
media communications into the round hole of the Agency’s existing rules developed for conventional media.” Pfizer’s
request for “comprehensive new rules describing the actions manufacturers must take in order for their online
communications to be truthful and non-misleading in the specific context of the online environment” reflects an
understanding of the unique challenges posed by Internet and social media for the highly regulated pharmaceutical
industry. The “guiding principles” identified by Pfizer reflect the specific context of social media and Internet sources
-- Pfizer acknowledged the challenges posed by consumer-generated content, the need for manufacturers to be able to
correct medically-inaccurate consumer information without that post being considered by the FDA as promotional
labeling or advertising, and the space limitations inherent to social media. Whether the FDA follows Pfizer’s
admonition to “establish new requirements for the Internet and social media that recognize their unique characteristics
and are informed by actual user behavior and expectations in these new media,” Pfizer’s comments present perhaps the
best summary of the challenges facing pharmaceutical companies as they seek to engage patients and consumers via the
Internet and social media.
12
Weber Shandwick, Digital Health: Building Social Confidence in Pharma, available at
http://www.webershandwick.com/uploads/news/files/Digital_Health_Study_2013.pdf (last visited Dec. 3, 2013). This
report presents information from 12 in-depth telephone interviews conducted at the end of 2012 with senior in-house
pharmaceutical executives responsible for social media decisions.
13
Id. The pharmaceutical executives interviewed for this study noted that while “social engagement is [ ] often deemed
a business risk by pharma companies,” they considered it “riskier to not engage than to engage.”
4
obvious potential to improve patient care and trust in the profession, in part by meeting patients
‘where they are,’ i.e., online,”14 the potential benefits of increased social media presence by
pharmaceutical companies include:
Advancing the public health by ensuring that reliable and accurate health and medication
information is available online.
The increased ease of accessing health information via Internet sources may lead to the
dissemination of false or even harmful information about disease states and medications.
Pharmaceutical companies are uniquely situated to provide complete and accurate information
about their products. Making this information readily available to consumers leads to increased
patient knowledge and increasingly productive discussions between patients and physicians.
Access to multiple, reliable sources of information about drugs and treatment options may reduce
the under-diagnosis and under-treatment of certain conditions while encouraging patients to
contact their health care providers. In turn, increased patient education can empower patients to
take charge of their health and increase patient compliance with treatment regimens.
Better monitoring and control of information about drug products.
Internet sites are flexible and allow information to be quickly updated, removed or edited,
allowing companies to release reliable and up-to-date medical information quickly and at
low cost.
Allowing regulatory agencies and pharmaceutical companies to communicate patient safety risks
and public health information quickly and cost-effectively.
Online sources allow pharmaceutical companies to coordinate with existing regulatory
tools such as MedWatch.15
Improving cost efficiencies with virtual marketing.
Online marketing allows pharmaceutical manufacturers to reach large audiences, at low
cost, while also targeting specific populations via specific patient forums.
Allowing pharmaceutical companies to “listen” to what consumers -- patients and physicians -are saying about its products.
“Listening” allows a pharmaceutical company to be more responsive to the needs of its
consumers.
The use of the Internet and social media by pharmaceutical companies to convey health
information is not without risk, however. Potential risks include:
The provision of incomplete information to patients by over-emphasizing benefits and omitting
risks, or by inaccurate consumer-generated content.
The highly interactive nature of social media sites may allow people unrelated to the
sponsoring company to post information -- potentially inaccurate, off-label or even
dangerous information -- about pharmaceutical products.
14
Matthew DeCamp, Physicians, Social Media, and Conflict of Interest, 28 J. GEN. INTERNAL MED. 299 (Feb.2013).
15
Bryan A. Liang & Timothy Mackey, Direct-to-Consumer Advertising with Interactive Internet Media: Global
Regulation and Public Health Issues, 305 JAMA 824 (Feb. 2011).
5
Apparent misbranding of drugs, leading to potential regulatory action.
Increased consumer demand for name-brand drugs (rather than cheaper generics).
Promotion of new drugs whose safety profiles are not yet fully known.
Space limitations (e.g., character limits for Twitter posts) may impact ability to disclose
important risk information.
These risks, however, can be mitigated with a properly conceived and executed social media
communication plan. While waiting for FDA guidance to define the parameters of use is the
safest (from a regulatory risk-minimization perspective) tack to take, pharmaceutical companies
should consider engaging with social media before the July 2014 FDA guidance deadline. The
swiftly changing online environment coupled with the nearly universal adoption of social media
by consumers may make it “riskier not to engage than to engage.”16
For those companies that wish to participate in the growing world of social media, the following
is a non-exhaustive list of issues in-house counsel should consider before embarking on any such
campaign.
Establish an overall social media policy,17 but remain flexible.
Any social media or Internet advertising policy should focus on an overall strategy, including
what social media engagement means to the company, with specific rules about how to comply
with current regulations. Any social media campaign should include employee training and
should provide a clear, comprehensive digital code of ethics.18 The policy and those responsible
for implementing the policy must remain flexible to account for different platforms and changing
regulations.
Engage a social media communications manager.
Given the highly regulated nature of pharmaceutical communications, the need to monitor content
on pharma-sponsored Internet and social medial sites is tantamount. In order to fully comply
with its regulatory obligations and to protect patient safety, pharmaceutical companies should
employ a well-trained, full-time social medial communications manager to oversee all aspects of
the company’s social media strategy.
This social media communications manager should develop a thorough understanding of how
social media can impact patients’ healthcare decisions and should use this information to improve
the company’s external online communications. This manager must also be aware of relevant
rule and regulations and must be prepared to monitor the company’s online presence.
16
Weber Shandwick, Digital Health: Building Social Confidence in Pharma, available
http://www.webershandwick.com/uploads/news/files/Digital_Health_Study_2013.pdf (last visited Dec. 3, 2013).
at
17
The FDA has stated that it is a “good idea” for companies to have a “robust policy in place for any type of promotion
about their products, including social media.” 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),
available
at
http://www.fdasm.com/docs/FINAL%20DDMAC%20Responses%20to%20FDASM_Questions.pdf (last visited Dec.
13, 2013).
18
While outside the scope of this article and therefore not discussed here, any social media policy should also address
how the employer intends to regulate employee social media use. On this regard, the policy must take into account
developments under the National Labor Relations Act (NLRA) as it relates to limiting an employer’s ability to regulate
employee social media use.
6
Rely on the current regulatory scheme to guide engagement with social media.
Until the FDA issues its final word regarding the use of social media in pharmaceutical
marketing, in-house counsel and marketing departments must operate within current regulations.
Under existing rules, communications must be “fair and balanced.” An advertisement does not
satisfy this standard if information about effectiveness is not balanced with side effects and
contraindications, if it is false or fails to reveal facts material to the drug’s indication. “Fair and
balanced” in the Internet and social media context has to take into account relevant space
limitations (e.g., the 140-character limit for Twitter).
Although limited, companies must comply with the 2011 Draft Guidance when responding to
unsolicited off-label information requests.19 This guidance requires that, if a pharmaceutical
company chooses to respond to publicly posted off-label information requests (for example as a
post on the company’s Facebook page), substantive responses should be provided only to the
specific individual who requested the information as a private, one-on-one communication.
While the company may issue a response on the public forum, the response should be limited to
providing only the firm’s contact information, disclose the company’s involvement, explain that
the question refers to an off-label use, and refer to the current FDA labeling.
Although tedious, scrutiny of individual warning letters20 against other companies may provide
in-house counsel with the best insight into the FDA’s current thinking about what is, and what is
not, appropriate social media and Internet advertising.
Choose media channels carefully.
In-house counsel and pharmaceutical companies must recognize that some social media platforms
are not appropriate for some audiences or to convey certain information. The company must
spend time determining which channels are best suited for the information the company wishes to
convey.
For example, if the advertising message and disclosure cannot be made in the limited number of
characters available, the medium is not appropriate because the claim will not be “fair and
balanced.” This caution applies specifically to Twitter feeds, which should not be used for
branded drug marketing as promotional claims and important risk information cannot be
conveyed within the 140-character limits.21 As noted below, Twitter feeds could be used,
however, to convey non-branded medical or scientific information or to encourage patients to
consult with their health care practitioners. Twitter feeds can also be used to direct consumers to
other websites where complete and balanced medication and prescribing information is available.
Regardless of which channels are used, disclosure and transparency are critical to garnering
patient and consumer trust. Important financial information must be disclosed by clearly
19
See Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs
and
Devices,
(Dec.
2011),
available
at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf.
20
See Jared A. Favole, FDA Warns Drug Firms Over Internet Ads, WALL ST. J. (Apr. 4, 2009), available at
http://online.wsj.com/news/articles/SB123879766861188121 (last visited Dec. 3, 2013). In 2009, the FDA warned 14
major pharmaceutical companies about brief Internet ads that accompanied searches on Google and other search
engines, saying the ads were misleading because they did not contain important risk information. The FDA’s letters
addressed five specific warnings that the advertisements violated regulations, including: (1) omission of risk
information; (2) minimization of risk information; (3) inadequate communication of indication; (4) overstatement of
efficacy; and (5) failure to use established brand names. Although issued in 2009, these letters indicate that the FDA’s
current position is that it will not permit Internet advertising where risk information is not readily accessible to the
reader.
21
Id. In-house counsel should be aware that the FDA has rejected the “one-click rule” proposed by some
pharmaceutical companies as a way to utilize space-limited websites, such as Twitter. Under the “one-click” rule,
important risk and labeling information was a single “click” away (via a hyperlink) from pharmaceutical-sponsored
Internet advertising.
7
identifying that a post or Internet site is pharma-sponsored. Risk information must be proximate
to the information so that the consumer does not have to search for this information.22
Consider using social media to convey only non-promotional and/or scientific medical
information.
Under current FDA regulations, not all product-related communications by a manufacturer are
subject to FDA oversight -- medical, scientific communications are not subject to review as
“promotion.”23 In accordance with these regulations, pharmaceutical companies should consider
restricting social media content to broad disease-state or disease-prevention forums.
Pharma-sponsored social media could also focus on informational communications that highlight
the benefits of a class of drugs and encourage patients to see their doctors to discuss treatment
choices.
Social media outlets could also be used to recruit patients for clinical trials or to test patient
questionnaires.
Consider limiting social media advertising to well-established drugs.
PhRMA, the industry trade group, has recommended that manufacturers delay promotional
campaigns for new drugs until after health professionals have been sufficiently educated.24
Consistent with PhRMA’s belief that “companies should spend an appropriate amount of time to
educate health professionals about a new medicine or a new therapeutic indication and to alert
them to the upcoming advertising campaign before commencing the first DTC [direct-toconsumer] campaign,” pharmaceutical companies should consider limiting online content to wellestablished drugs, whose risks and benefits are well-known to health professionals.
Monitor online content to ensure patient safety.
One of the markers of Web 2.0 is the ready ability for information to be changed. Unlike a static,
company-hosted website, social media users are often free to post whatever information they
want,25 and these posts may be inaccurate or include information about a product that is not
supported by clinical evidence. In light of this, before launching any social media campaign, in-
22
The Federal Trade Commission (FTC), which governs advertising of non-prescription products to consumers,
recently released disclosure rules regarding social media and Internet advertising. While not exactly applicable to the
pharmaceutical industry, the recent guidelines offer some insight into how a regulatory agency has approached social
media advertising and provide some helpful guideposts while pharmaceutical companies await the FDA guidelines.
See Federal Trade Commission, Dot Com Disclosures -- How to Make Effective Disclosures in Digital Advertising,
(Mar. 2013). FTC rules require that disclosures in online advertisements be “clear and conspicuous” and proximate to
the claim it qualifies. FTC rules also provide that “[d]isclosures that are an integral part of a claim or inseparable from
it should not be communicated through a hyperlink” and “[i]nstead, they should be placed on the same page and
immediately next to the claim, and be sufficiently prominent so that the claim and disclosure are read at the same time,
without referring the consumer somewhere else to obtain this important information.”
23
See, e.g., 21 C.F.R. § 312.7(a) (FDA does not regulate product-specific “scientific exchange” by manufacturers).
24
See PhRMA Guiding Principles -- Direct to Consumer Advertisements About Prescription Medicines, available at
http://phrma.org/sites/default/files/pdf/phrmaguidingprinciplesdec08final.pdf (last visited Dec. 3, 2013).
25
Since August 2011, Facebook has required all pharmaceutical companies using Facebook pages to allow other
Facebook users to comment on their pages. With this change, pharmaceutical companies are less able to control the
content of conversations on their Facebook pages, although they are still able to control the creation of original content
or posts. See Intouch Solutions, How Facebook’s New Comment Policy Impacts Your Pharma Facebook Page,
available at http://www.intouchsol.com/Libraries/Article_PDFs/Facebook_Comment_Policy_POV.sflb.ashx (last
visited Dec. 12, 2013).
8
house legal counsel and pharmaceutical marketing teams should have a plan about how the
company intends to address inappropriate or inaccurate content posted to its sites.
Companies must make clear that their sites are monitored and that the company will remove or
correct any user-generated content that makes unverified comments or gives inappropriate
clinical advice. And while the FDA has not indicated whether it intends to hold manufacturers
and pharmaceutical companies responsible for content posted by unaffiliated third-parties, a wise
policy would be to take steps to ensure that sponsored substantiated marketing statements are
distinguished from consumer statements posted on social media.
Companies hosting social media sites should also review information posted about adverse
experiences to determine whether the description of the adverse event constitutes adverse event
reports which must be reported to the FDA.26
Work to improve patient comprehension of online health sources.
All information posted on online sources should be presented in easy-to-read text and at an
appropriate literacy level to increase patient understanding.
Claims and information should include quantitative information about potential benefits and risks
of advertised drugs to provide a realistic assessment of the advertised product.
Ensure that online promotional information is not accessed globally.
Given that the rules regarding the communication of health information and prescription drug
information differ worldwide (e.g., DTC advertising is legal only in the United States and New
Zealand), pharmaceutical companies should actively survey and block foreign Internet protocol
addresses from accessing US-based online DTC content.
Conclusion
Even though the FDA has yet to issue clear guidance on the “do’s and don’ts” of using social
media, online communications have become a principal channel for information exchange and
pharmaceutical companies must begin to understand how to engage with consumers via these
channels, or risk being left behind. By viewing social media engagement over the long term,
customizing content to select user communities, listening to user feedback, and navigating the
current regulatory environment by adhering to best practices, pharmaceutical companies should
be able to safely and effectively incorporate social media into their marketing and communication
strategies.
26
While fears that “encouraging consumers to post publicly on social medial sites will inundate [pharmaceutical
companies] with reports of adverse drug experiences” have “prevented many pharmaceutical companies from taking
real advantage of” social media, these fears appear largely unfounded. See S. Friedel & J. Sena, Jr., Pharma
Challenges: Adverse Event Reporting and Social Media, available at http://about.bloomberglaw.com/practitionercontributions/pharma-challenges-adverse-event-reporting-and-social-media/ (last visited Dec. 12, 2013). Friedel and
Sena report that in 2008, the Nielsen Company published results of a study that analyzed 500 randomly selected
healthcare-related messages on non-pharmaceutical social media sites and found that only one satisfied the FDA’s four
standard adverse event reporting requirements (specific medication, adverse experience, identifiable patient, and
identifiable reporter). Id. The study indicated that social media posts about adverse experiences will often fail to
provide the last two required data elements of a reportable event due to the anonymity of social media membership.
Friedel and Sena suggest other ways to mitigate the risks related to adverse event reporting, including “website policies
with commenting guidelines that advise patients not to mention the specific events or personally identifiable
information,” or “clearly direct patients with this information to the FDA.” Id.
9