FDASM Highlights for UM Stakeholders, pt. 1: Early Presenters as SWOT-Plus

Here at the University of Michigan, our healthcare community is encouraging engagement with the Food and Drug Administration’s process for helping to inform their development of social media and online presence guidelines. We are doing this through the opportunity to view the FDASM webcast together or individually, discuss at the time, and contribute to a community discussion at our own public forum next month. As part of this process I am trying to tease out a few of the discussion topics and presentation topics that seem most important and relevant to our own community.

For context, I am thinking of these guidelines as having the potential to control healthcare communications relating to drugs and devices as powerfully as HIPAA controls personal health information communications. This perspective is clearly not something that is mine alone, as it is reflected in some of the presentations in the webcast.

Most notably Peter Pitts from the Center for Medicine in the Public Interest at minute marker 40:00 of the webcast (November 12) mentioned a recent European legislative guideline that seems to hold John Q Public commenting on healthcare information in personal experience as liable for the accuracy of the health information as a healthcare professional. Dr. Pitts was concerned that this gives the government carte blanc for a gag order on any healthcare topic. I’ll go into this more in a future blogpost, for for now as a medical librarian, I am struggling to think of how I could do my job. What our librarians have done to protect themselves from lawsuits is formed the habit of prefacing health information with a disclaimer, “I am only a medical librarian, not a doctor. You should always trust your doctor more than anything you hear from anyone else.” or something along those lines. We felt safe as long as we said, “I’m only a librarian,” but there is now some real question as to whether that will continue to be any kind of protection.

Main questions being addressed.

1. For what online communications are manufacturers, packers, or distributors accountable?

2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?

3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?

4. When is the use of links appropriate?

5. Questions specific to Internet adverse event reporting

FROM: Federal Register Notice of Public Hearing:

Main issues & themes identified in the presentations of November 12, early morning.


The discussion in this section was mostly about how the Internet is similar or different from other communication media. Most commonly, it was compared to television, radio, and print marketing media.

Key aspects noted included these:
* a dynamic and static medium
* unlike broadcast media

Concerns mentioned:
* currently the go-to medium for health information, but also a “breeding ground for biased and inaccurate information”
* health literacy remains an issue in all media
* internet access is now essential to preserving health and accessing health information, the digital divide is increasingly a public health issue
* the quantity of information available is at a scale never seen before
* personal relationships and trust building form the core of information transfer, but these core factors have changed in the new online environments to more distant and numerous relationships
* defining the authority and credibility of health information remains a sometimes lacking skill

Online behaviors of healthcare consumers:
* health engagement
* health seeking
* medical portals
* conversation
* collaboration
* participation
* content creation
* community creation
* e-advocacy (becoming and finding influencers)

Goals of the FDA:
* provide accurate and timely information
* provide scientifically based information
* support protection of the American public from health scams
* support promoting healthy choices and behaviors with respect to the regulated areas

Take Home Points:
* Patients are taking more ownership of their healthcare decisions and those of their loved ones
* The internet has opened access to information, and it will not be closed again


Social media can educate and inform and empower. It can raise awareness of new treatments, technologies, options, tools, and inform decisionmaking. It is especially potent for patients with rare conditions and those who are homebound or rural or who in other ways find themselves challenged to access offline information sources. The power and public health promise of the e-patient revolution and of the medium should not be underestimated.

The FDA is already doing amazing things to protect public, with H1N1 as an example of highlighting scams and pointing to useful information.

FDA: Fraudulent 2009 H1N1 Influenza Products List: http://www.accessdata.fda.gov/scripts/h1n1flu/

Risk Communication Advisory Committee: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/default.htm


FDA online information includes excellent resources, but needs to be more accessible, especially in the sense of being discoverable and visible to the public.

Current problematic marketing practices:
– interactive video games, shooter games used to market prescription drugs
– celebrity endorsements
– banner advertisements

General Concerns:
– Links are great ways to share excellent content, but content at the directed source may change
– Wikipedia is a popular information resource that has open content editable by anyone (both experts and those with bias or misinformation), the control of authority and identity of authority is lacking for the typical user.

Industry & FDA Related Concerns:
– There is a lack of clarity regarding FDA’s expectations, regulatory ambiguity
– Some companies avoid social media to avoid hearing or knowing what’s wrong, so they don’t have to fix it (ignorance is bliss)
– Some companies avoid social media to avoid being held culpable for what is said there by others
– Some companies avoid social media to avoid the risk of well-intentioned statements being misinterpreted and being penalized
– Requiring proximity of disclosures can be problematic in an online environment with popups and other flexible and sometimes uncontrollable design elements
– Warning letters about Internet advertisements earlier this year created concern and confusion.

FDA: Warning Letters 2009: Internet Marketing of Unapproved and Misbranded Drugs: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055773.htm

Take Home Messages:
* There need to be "safe spaces" for healthcare consumers, easy ways to discover these safe spaces, ways to counter fraud & inaccuracies
* Industry is largely paralyzed with fear of doing the wrong thing in innocence following the warning letters earlier this year and some recent lawsuits
* Excluding industry from the public conversation impoverishes all, reduces access to the high quality information held by industry, makes discovery of risks and errors a slower process, and places the public at risk – there must to be ways to encourage companies to promote the public good through social media

Opportunities / Models

* Become gold standard for professionals, consumers and caregivers
* Protect and foster public health in public spheres of influence
* Find people on a mass scale not limited by geography or time
* Increase the speed of adverse event reporting through crowdsourcing
* Leverage the power of existing and new patient communities to solicit information, feedback, and promote awareness and adoption of relevant public health information.
* Support and create opportunities for dialogue between care providers and patients is very very important in clinical care
* Promote public awareness of public health issues related to disease, public health practices, drug interactions, device and procedure risks, and more
* Support and leverage philanthropic outreach for the good of the American public
* Prepare policy that will be flexible enough for new and changing tech, facilitating evolving technologies to provide opportunities, not barriers
* Provide FDA leadership to the pharmacy industryin disseminating high quality information from both government and industry sources
* Foster collaboration, boundary spanning and increased information flow between healthcare consumers and providers, providers and industry, consumers and industry, and all of these with government and advocacy organizations
* Online environments can increase the robust accessibility and understandability of health, addressing some health literacy issues through the social network and support for individual s who need assistance in these areas. Leverage health literacy solutions through social networks and crowdsourcing

Examples of responsible use of social media are available to study from the White House and FDA_Drug_Info on Twitter. The FTC activities and rules about obesity and marketing may serve as a good model for how the FDA might engage with their constituents.

FTC: Sizing Up Food Marketing and Childhood Obesity: http://www.ftc.gov/bcp/workshops/sizingup/

Take Home Points:
Social media is best tool for achieving the goals of advancing the bottom line and promoting the public good, NOT in that order, but requires support and leadership for all stakeholders to benefit and engage equitably.

Threats / Challenges

What has kept the pharmacy industry from more active engagement with social media? Partly unanswered questions about internet promotion, partly lack of leadership, partly concerns about risks.

The FDA, the pharmacy industry, other healthcare industries must all be visible and relevant where people are already looking (both in online spaces and social media, even gaming if that is where the people are).

There are unintended consequences of providing no leadership. Uncertainty keeps industry on sidelines. Through lack of overt information, industry speakers are forced to derive implied policy from actions of the FDA, such as the worrisome Letters of Warning from early 2009. This leads to a fear of engagement, hesitancy, and silence from one of the healthcare stakeholder audiences with the richest information to share.

Concerns exist that too many or overly confining restrictions, may silence important voices. Impact of forced silence includes reduced research productivity (shutting down open science initiatives), slowed dissemination of important research findings and clinical guidelines, impaired communications and trust between stakeholder communities.

What if a third party speaker is prompted by industry representatives or rewards, implied or overt, virtual or real? Where does the responsibility and accountability lie? If incentives are disallowed, will this reduce access to crowdsourcing for collaborative problem solving? Are some incentives acceptable, such as virtual, while others are not, such as money?

When misinformation appears in a public space, what mechanisms should be in place for correcting it? What criteria should determine if it should be corrected? What if the system or environment in that space do not support or allow changes or corrections? What if corrections don’t “stick”, or if the original wrong information is archived elsewhere on the web in its original form?

Google Sidewiki poses special risks, and serves as an illustration of how technology rapidly changes to provide new communication forums not predicted even short times beforehand. Sidewiki gives the original content owner minimal to no control over comments on their content, and gives unusual power to fabricated information. Who is responsible for comments made in Sidewiki? Who can and cannot control conversation? Who should?

Take Home Point:
“If we don’t engage, the snakeoil vendors rule the space.” Peter Pitts

Strategies / Suggestions / Recommendations

Transparency is essential among all healthcare stakeholders, but especially for leaders in the healthcare space, such as industry and government. Covert activities and communications must be extremely limited only to those that would cause harm. Communication should err on the side of transparency when uncertain.

When should marketers be held responsible? 3Cs:
– creation (was content unaltered from that provided by the company?)
– collaboration
– compensation
NOTE: Collaboration is different than merely linking to another site, being more focused on creation of new content.

Marketers and industry hold some types of influence over third party content creators: funding, hiring as consultant, wining/dining or other relatively informal incentives. Are these equivalent as influencers of content? How do we distinguish in social media environments between formal and informal incentives as a source of influence? What about games in social networks and virtual environments? They can provide incentives for disseminating information, or can serve as influencers of opinion. How to clarify these subtle differences?

Are grants as funding motivation equivalent to or different from marketing in the eyes of the FDA? Can independent grants truly be independent or do they influence content produced to the point where the phrase is an oxymoron? If the latter, can mechanisms be put into place to ensure grants are truly independent?

Suggested best practices:
– disclosure displayed adjacent to content
– a social media POLICY publicly available
– approved content
– brief intro + link to full + risks logo/graphic

Ideas for managing disclosure:
– use logos and graphic displays for disclosure
– include universal safety symbol
– warning symbol to identify risks
– FDA-approved content logo
– Use a hashtag for branded tweets, assigned by FDA. This may replace 2253 submission, facilitates monitoring for enforcement, addresses space limitations of social media like Twitter.
– Comment: logo idea doesn’t allow for easy monitoring / tracking.

Managing policing and correction of misinformation:
– Where lies the responsibility for policing and correcting misinformation? When, when not, obligations, penalties, best practices, guidelines need to be established and communicated clearly.
– High profile info should get more attention, but based on what metrics? How should industry measure level of influence? Should industry depend on third party assessors such as Google to determine influence, or should government provide impartial tools to determine influence?
– If misinformation is corrected on a site, by comment or change, should the site be monitor for the future? For how long? Is it always POSSIBLE to get information corrected? If not, should the site be monitored?

Additional ideas:
– Strengthen intergovernmental cooperation and collaboration with respect to the healthcare sphere, especially between the FDA and FTC, CMS, CDC, NIH and HHS.
– Encourage and support studies of populations to find out what is used, how, and why.
– Define best practices for use of social media for promoting the public good.
– The FDA needs to provide quick visible enforcement of defined policies and guidelines
– Leverage innovative initiatives.
– Foster and support innovation as ways to engage community, enrich data sources, utilize crowdsourcing for more rapid identification of significant trends and patterns.
– Lead a series of FDA public workshops on social media use.
– Distinguish promotional content versus media the industry cannot control.
– Interactive versus static media may require different guidelines and strategies
– Allow commenting, but prescreen all comments, refuse to allow mention of any products. (It is easy for comments stray to off-label conversation.)
– Different platforms may require different guidelines.
– Regulated companies must not be allowed to feel safe by not engaging, rather social media engagement should be encouraged as an expected practice leading to working for the public good.
– Offsite links should open in new window or tab following a disclaimer.
– Employees in role of their position should be held to full disclosure and scientific accuracy.

definition of misinformation varies
at what point is correcting misinformation censorship and silencing important voices

Other Questions Needing Answers

1. How to assess, track, and assign metrics; how to identify and flag online communications for future review?
2. What would be best practices for the FDA in their adoption of social media?
3. What should be the role of health professionals and health care providers?
4. How do various presentation formats impact differently (or not) on public health? Example: smoking cessation.
5. Who is required to presubmit what content for approval? How would the approval process work for online info?


2 responses to “FDASM Highlights for UM Stakeholders, pt. 1: Early Presenters as SWOT-Plus

  1. Pingback: FDASM Highlights for UM Stakeholders: Things I’m Reading « Emerging Technologies Librarian

  2. Pingback: Social medias, web services and tips for health in MedLib’s Round 1.9 | Knowledge beyond words

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s