The Food and Drug Administration (FDA) will hold a public hearing to provide an opportunity for broad public participation and comment on promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.
- FDA has obtained significant input from within and outside FDA, including testimony and comments from the Part 15 hearing on the use of Internet/social media for promotion of FDA-regulated medical products.To see the related guidances that have been issued, please visit the Office of Prescription Drug Promotion’s social media guidances webpage.
- Please use the following link to access an archived copy of the two-day public hearing on November 12-13, 2009. Archived Webcast of meeting .
- These PDFS can be found on our archived page: Agenda (PDF - 35KB) | Speakers (PDF - 40KB) | FDA Panelists (PDF - 19KB) | Presentations
Hearing Date: November 12 and 13, 2009
Hearing Name: Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools
Location: National Transportation and Safety Board Conference Center, 429 L’Enfant Plaza, SW., Washington, DC 20594
Time: 8:00 a.m. to 5:00 p.m. each day
Federal Register Notice of Public Hearing:
Contact for Questions: Jean-Ah Kang, Division of Drug Marketing, Advertising, and Communications, telephone: 301.796.4269, fax: 301.847.8444, email: InternetPublicMeeting@fda.hhs.gov
Submitting Comments: Written or electronic comments will be accepted until February 28, 2010.
Submit written comments to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments, identified with docket number FDA-2009-N-0441, to http://www.regulations.gov.
- Transcript of Day 1 on November 12, 2009 (PDF - 781 KB)
- Transcript of Day 2 on November 13, 2009 (PDF - 798 KB)
Directions to the NTSB Conference Center:
- Take METRO to L’Enfant Plaza station on the yellow, green, orange, and blue lines
- See: http://www.ntsb.gov/events/newlocation.htm (FDA has verified the Web site address, but FDA is not responsible for any changes to the Web site after the Federal Register notice publication)