UPDATE: The date has been changed. Please see below for details.
FDASM = The FDA’s process to develop guidelines for health information in social media and online spaces. I think of it as this:
can say WHAT
about health information.
February 16, 2010, Tuesday
12 noon to 1:30pm
Dow Auditorium, Towsley Center
WikiMapia Directions: http://wikimapia.org/2163107/Towsley-Center-for-Continuing-Medical-Education
* Patricia Anderson, Emerging Technologies Librarian, Health Sciences Libraries
* Ted Hanss, Director for Enabling Technologies, UMMS
* Anuja Jain, Medical Student, Social Media Research Project, UMMS
* Brenda Jones, Managing Director, Medical Innovation Center, UMHS
* Mary Kratz, Senior Advisor, Health Informatics, President’s Emergency Plan for AIDS Relief, U.S. Naval Health Research Center & UMMS
* Melissa Levine, Copyright Officer, University Libraries
* Jessica Souliere, Senior Public Relations Representative and Social Media Communications Coordinator, UMHS
* and YOU!!!
February 16, noon-1:30 in Dow Auditorium, there will be a campus public forum on the FDA’s guidelines for health information in social media. These guidelines will influence who can say what to whom where online regarding health information. Examples of potential impact areas include communications between clinicians with peers or patients, recruitment for clinical research, promotion of research findings or clinical guidelines, and much more. Learn how you can influence the FDA in their process to develop these guidelines by sharing your thoughts, hopes and concerns with your peers here and with the FDA.
Feb. 4, 2010
For more information, contact:
Jessica Soulliere, firstname.lastname@example.org
For immediate release
U-M hosts forum on use of social media, Internet to promote FDA-regulated medical products
Public invited to give input for recommendations to FDA
ANN ARBOR, Mich.—The University of Michigan Health System invites members of the public to attend a free community forum to discuss how industry should be allowed to use social media and the Internet to promote Food and Drug Administration-regulated medical products such as prescription drugs for humans and animals, prescription biologics and medical devices.
The event, which includes a panel of experts from UMHS, will take place from noon – 1:30 p.m. Tuesday, Feb. 16, in Dow Auditorium, Towsley Center, 1500 E. Medical Center Dr.
On Nov. 13 and 14, 2009, the FDA hosted a 15-part hearing encompassing 76 presentations entitled, “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools,” to begin gathering input from the public on how future policies in this area should be developed.
The FDA is specifically seeking input on five questions:
1. For what online communications should manufacturers, packers or distributors be accountable?
2. How can manufacturers, packers or distributors fulfill regulatory 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?
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? And
5. How should Internet adverse event reporting take place?
Public participation is encouraged from any interested party, including consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies and the regulated industry.
Recommendations developed during the Feb. 16 forum will be submitted to the FDA for consideration in making future policy decisions on this issue.
For a complete primer on the issue, including links to Web casts of the original hearings, industry commentary and new developments in the conversation, visit http://fdasm.com/.
Map to the Towsley Center: http://www2.med.umich.edu/healthcenters/gmaps/medcenter.cfm
ETechLib: FDASM: https://etechlib.wordpress.com/tag/fdasm/
Event (this page): https://etechlib.wordpress.com/2010/02/01/fdasm-university-of-michigan-campus-forum/
Downloadable & embeddable copy of the poster here: http://www.slideshare.net/umhealthscienceslibraries/fdasm-event-poster-feb16
CDC in Social Media: http://www.cdc.gov/socialmedia
FDA in Social Media: http://www.fda.gov/socialmedia
FDA: About the Hearings: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm
Comments currently in the docket (Docket ID: FDA-2009-N-0441) at Regulations.gov: http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2009-N-0441
Introduction to the FDASM (slides from a presentation given in Second Life on December 13th): http://slideshare.net/umhealthscienceslibraries/introduction-to-the-fdasm