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Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools

National Transportation Safety Board Conference Center

429 L’Enfant Plaza, SW., Washington DC, 20594

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. We have developed a variety of guidance concepts including: how companies should respond to unsolicited requests for information about off-label use, issues with space limitations, fulfilling post-marketing submission requirements, accountability, use of links on the Internet, and how sponsors should correct misinformation about their products disseminated by third parties. Despite our limited resources and increasing workload, OPDP remains committed to providing guidance and clarification to industry in this area in terms of both Agency time and human resources.
  • FDA issued a draft guidance that addresses some issues related to the use of social media in December 2011. The draft guidance, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, outlines FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) related to their FDA-approved or cleared products, including those that firms may encounter through emerging electronic media.
  • 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 Exit Disclaimer

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:

http://edocket.access.gpo.gov/2009/E9-22618.htm

http://edocket.access.gpo.gov/2009/pdf/E9-22618.pdf

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.

Transcripts: 

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)