FROM:

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

TO:

Division of Dockets Management (HFA305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

RE:

DOCKET: FDA-2009-N-0441

DATE:

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

1. Accountability

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.

Disclaimers should:

- 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 the policies.

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

No comment.

Additional Topics/Questions of Import

Examples of Social Media Use in Healthcare Within the University of Michigan Communities

* Education

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

* Research

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 5R03NS065491-02 $39,058

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 6:1085.

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.

* Marketing

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?

- Examples

Flickr used in support of medical care delivery for Haiti disaster and community engagement

Twitter accounts used for hospital marketing serve dual purpose for outreach, education, and community engagement.

* Outreach

- Examples

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

http://www.mindmeister.com/41914191/health-communities/

Envisioning Uses of Social Media in Healthcare Communications

* 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 authorized speakers.

- 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 members contributing.

* 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 recommendations;

- 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.

Closing Thoughts

"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 reactionary thinking.

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, 2010.