The document summarizes an introduction to the FDA Social Media Hearing (FDASM). It provides background on the purpose of the hearing, which is to get public input on how expanded web technologies can be used to promote medical products to healthcare professionals and consumers in a truthful manner, and on internet adverse event reporting. The main questions to be addressed at the hearing are about accountability, regulatory requirements for social media promotion, corrective information on third party sites, appropriate use of links, and adverse event reporting. Highlights from a previous forum on related issues are also summarized.
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FDA Social Media Guidelines - Introduction
1. Introduction to the
FDASM
PF Anderson, Emerging Technologies Librarian for the
Health Sciences, University of Michigan
School of Dentistry Bootcamp, February 10, 2010
4. FDA’s Stated Purpose
This hearing is intended to provide an opportunity for broad public
participation and comment concerning Internet promotion of FDA-
regulated medical products, including human and animal prescription
drugs and biologics and medical devices. Please note that this hearing
does not address nonprescription drug promotion. FDA is particularly
interested in hearing views from the public as to how expanding Web
2.0 technologies may be used to promote medical products to both
health care professionals and consumers in a truthful, nonmisleading,
and balanced manner. In addition, FDA is seeking public comment on
Internet adverse event reporting.
5. FDA’s Purpose: Main Points
Internet promotion of FDA-regulated medical products
human/animal prescription drugs
biologics
medical devices
does NOT address nonprescription drug promotion
Web 2.0 use to promote medical products
to both health care professionals and consumers
in a truthful, nonmisleading, and balanced manner
Internet adverse event reporting
7. Who, What, Where, Why
Who
is allowed to say What
to Whom
regarding health information
Where in online spaces and social media?
Are Why & When & How part of the question/answer?
10. 1. For what online communications are manufacturers,
packers, or distributors accountable?
FROM: Federal Register Notice of Public Hearing:
http://edocket.access.gpo.gov/2009/E9-22618.htm
11. 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)?
FROM: Federal Register Notice of Public Hearing:
http://edocket.access.gpo.gov/2009/E9-22618.htm
12. 3. What parameters should apply to the posting of corrective
information on Web sites controlled by third parties?
FROM: Federal Register Notice of Public Hearing:
http://edocket.access.gpo.gov/2009/E9-22618.htm
13. 4. When is the use of links appropriate?
5. Questions specific to Internet adverse event reporting
FROM: Federal Register Notice of Public Hearing:
http://edocket.access.gpo.gov/2009/E9-22618.htm
21. 1. Outbound Links
Who is responsible if the target link changes content or
location?
Who should be required to use in-between page warning
consumer they are leaving the site? What about groups that
don’t have the skills or resources necessary to do so?
23. 3. Spurious content
Who decides what is good and what is not?
Who should be held accountable for the quality of the
information provided?
What should be asked of those who provide questionable
content?
24.
25. 4. Off-Label Use
When is emerging research beneficial or dangerous to a
healthcare consumer?
Who decides?
Should conversations on off-label use be supported,
discouraged or managed?
26. 5. European Precedents
Title VIII, Advertising, Article 86 (Denmark)
”Directive 2001/83/EC on the Community code relating to medicinal
products for human use” in conflict with “The European Convention
for the protection of human rights and fundamental freedoms”
The European Court of Justice: Third-party statements about
medicines may be advertising: http://www.dkma.dk/1024/
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Digital Economy Bill (in progress, UK)
Clause 11
27.
28. Maybe, instead of banning all kinds of opinions on
particular product, one should think of a better way to
distinguish independent journalism from mere
marketing strategies. The question is how?
40. Think about your concerns and hopes for the forthcoming
guidelines. Register your comments NOW.
FDA will have a second 90-day comment period after the
initial guidelines are proposed.