FDA-2009-N-0441 Docket Comments, University of Michigan Public Forum
PF Anderson, as moderator of the University of Michigan Public Forum on the FDASM
PF Anderson, Health Sciences Libraries, University of Michigan, 1135 East Catherine
Ave, Ann Arbor, Michigan, 48109
Division of Dockets Management (HFA305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
February 28, 2010
This document shares brief comments and observations about the FDA social media
guideline development process from a public forum held on February 16, 2010 at the
Dow Auditorium of the University of Michigan Health System. This represents the
opinions shared at that meeting and does not represent a formal stance of the
University of Michigan as an entity.
Core FDA Questions
There is a need to clarify the purpose of disclaimers and improve appropriate and
helpful use of disclaimers in all media, not just social media or online spaces.
Broadcast media currently exhibits compliance with disclaimer standards, however
currently disclaimers often fail to fulfill the intended function of protecting or
informing the general public.
- disclose identity of speaker;
- disclose association with information presented;
- not insulate speaker from source, but connect audience, speaker and authoritative
sources of information;
- ideally also establish credibility and authority of information presented.
NOTE: Disclaimers provide an opportunity to connect presentation of health
information to health literacy support.
2. Regulatory requirements best practices
Wherever possible, rely on existing laws and guidelines to manage regulated speech
in social media and online spaces. Focus new policies instead on implementation of
Encourage and facilitate engagement of all healthcare stakeholders in broad
discussions. The general public and patients are more dynamically engaged in
assertive seeking and personal use of healthcare information than in previous times,
and as stakeholders in participatory medicine are not likely to welcome health
information management that appears to present itself as censorship or control.
3. Corrective information
This, perhaps more than any other area, has the potential to be perceived as
interfering with free speech of the public or creating an undue and insupportable
burden for industry and the healthcare communities. In many healthcare
communities the need for corrective information is obviated by the self-policing of
the community themselves. Wherever possible resolving the need for corrective
information through the community's own internal processes is preferential to
inserting an outside agency into the conversation. It is appropriate to encourage
stakeholders, including clinicians and pharma / industry, to join in these online
communities and support their discussions as equal members. It would be useful to
have examples of best and worst practices in online conversations, much as the
PlainLanguage.gov site does with before and after examples of healthcare
communication in support of health literacy.
4. Outbound Links
While a standard best practice for outbound links is to provide an interim page
warning people they are leaving the site, this may be impractical to require in social
media (such as Twitter) or may be burdensome for consumer maintained and
supported sites due to lack of expertise or resources. The FDA should be aware of
the distinction between encouraging this as a best practice or an expectation for
larger sites or those from industry, while respecting the balance and not imposing
this requirement on communities without the resources to implement it.
5. Adverse event reporting
Additional Topics/Questions of Import
Examples of Social Media Use in Healthcare Within the University of Michigan
The Open Education Resource (OER) movement, of which the University of Michigan
is a leader, depends on the freedom of speech of local faculty to express views and
concerns freely in the context of their classes, and to then share the videos of those
lectures and conversations freely in public online spaces. Some of the University of
Michigan health care faculty have expressed concerns about social media risks and
accountability. If the FDA were, for example, to limit public conversation about off-
label uses of drugs or medical treatments in public online spaces, this could have the
unfortunate side effect of restricting free speech and enquiry in the classroom for
those faculty contributing their materials to OER repositories, or impairing the future
growth of the OER movement if OER repositories were required to review and edit
out lecture comments and discussions that touched on potentially regulated topics.
This would impair not only the sharing of educational resources but also access to
these resources for other countries and collaborators who depend on this content to
enrich education and the standards of healthcare in their areas.
Medical students here have expressed concerns about professionalism and
transparency as potentially conflicting aspects of social media. As long as persons
are held to standards of behavior and accountability based in a world view where
information about a person was limited to the physical spaces they inhabit this
conflict will persist. When our culture has evolved new standards of ethics and
etiquette based around social behaviors in public online spaces, then transparency of
the individual may lead to empowerment and enrichment of the broader community.
During this transition time, the FDA may wish to avoid creating policies that seek
permanent solutions to what is likely to be a temporary conflict.
- Other Examples
• Facebook for student recruitment and retention (Medical School)
• Student blogs (School of Public Health)
• Course lectures and discussions videotaped for online use (Medical School,
School of Dentistry, School of Nursing)
• Shareable online flashcards with mobile smartphone support for collaborative
distance studying and review
Regulatory guidelines should embrace and support rich discussions that empower
discovery of resources and support for the individual as well as facilitation
collaboration between stakeholders of a condition and the researchers exploring that
condition. In addition, it would be helpful to future research, especially in the area of
public health, to preserve access to public social media streams as a potential data
source for tracking and predicting health trends and behaviors.
- Examples of Grants for Research Including Social Media Aspects or Engagement
Dorene S. Markel. Engaging the Community in Clinical Research. NINDS 2009
Jose A Bauermeister. HIV/AIDS Risk Among Young Men Who Use the Internet. NIMH
2010 1K01MH087242-01A1 $137,009
Marc A. Zimmerman. Virtual Network Influences on Young Adults' Alcohol and Drug
Use. NIDA 2009 1RC1DA028061-01 $464,720
- Examples of Potential and Actual Social Media Use Related to Research Projects
Patel R, Hanratty M, Johnson J, Saxman P, Shah A, Zheng K. Casepedia: a Web 2.0
case repository enabling collaborative learning. AMIA Annu Symp Proc. 2008 Nov
Campbell DA. Quality Improvement Is Local: Surgical Perspective. J Am Coll Surg
209(1) July 2009:141-143.
Subjects recruited for surveys or research studies via social media, including
targeted email, Twitter, Facebook, and Second Life.
Data harvested from social media spaces for research. Example: Google Flu Trends
could be enriched through integration of geotagged Twitter posts.
Academic medical centers routinely release press releases regarding emerging
research ongoing at their institutions. If the research topic includes what would be
off-label use in current practice, how can this be communicated appropriately to the
public as an emerging area of research without restricting medical and health care
journalism and free speech?
Flickr used in support of medical care delivery for Haiti disaster and community
Twitter accounts used for hospital marketing serve dual purpose for outreach,
education, and community engagement.
Social media use for communities and interventions for HIV prevention in Africa and
as a support for mobile health.
UMHS scheduled H1N1 question and answer session with clinical experts to address
questions form the public via Twitter.
Examples of Social Media Use in Healthcare Broadly
Envisioning Uses of Social Media in Healthcare
* Best Practices to Support
- Institutions should develop and promote social media plans and guidelines.
- Individuals speaking on behalf of their institution should request and receive
permissions to do so, and institutions should provide clear ways to identify
- Institutions should provide training or support on institutional context,
communications policies, goals, priorities and mandates for authorized speakers.
- Individuals should be aware that even speaking as a private individual may be
perceived by public as representing the institution, however institutions should not
be held to account for private speech either by customers/patients of the institution
nor by individuals associated with the institution but not authorized as speakers.
* Crowdsourcing via Social Media
Social media discussions could potentially serve as data sources to gather
information relevant to healthcare planning, support, outreach, research and more.
- Gather data from patients about drugs reactions and/or effective treatments.
- Input from patients, patient advocates and primary care clinicians on what
research is most needed.
- Community policing, or assessment and recommendation of health information
resources, authority, accuracy.
As a model of potential use, please consider GalaxyZoo - a social networking game in
the field of astronomy in which an international community is engaged in the
cataloging deep space images of galaxies through training. The project has shown
that, following the initial training of the community members, when a certain level of
consensus is reached among the community about a particular image, that decision
tends to be accurate irregardless of the background and expertise of community
* Balance Between Over- and Under-Regulation
Social media is still a rapidly evolving domain. It is critical to:
- err on the side of caution and flexibility in developing guidelines and
- incorporate a mechanism for adaptive change of guidelines;
- establish a core community of practice within the FDA to continue developing
expertise with social media;
- establish safe online community discussion spaces for FDA to engage with their
stakeholders (including industry, healthcare, and the public) on topics of import.
"The FDA needs to find a narrow winding road up a steep mountain that leads to real
evidence based medicine.
Too much regulation creates an atmosphere of fear, government distrust and
Too little regulation leads to graft, greed, corruption and disinformation.
Evidence based medicine means doing the right things for the right reasons."
- Dr. Ren Stonecutter, at the Second Life Public Forum on the FDASM, January 30,