FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation

The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010. 

By mid December, the transcript for the meeting will be available under the Division of Dockets Management, available online. Issues that will be discussed include the distinction between when a product is being promoted and when it is being advertised, and the reporting of adverse event data. Further, how often and to what extent companies, consumers, and health care professionals use social media (Twitter, Facebook, wikis, blogs, video sharing, etc) to promote topics of public health and how they are impacted by such promotion will also be examined. The following discussion questions are a sample of those that will be posed at the public hearing. For more information, visit the official notice in the Federal Register

  • For what online communications are manufacturers, packers, or distributors accountable?
  • 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)?
  • What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
  • When is the use of links appropriate? (The FDA prohibits manufacturers, packers, or distributors from promoting their product for unapproved uses. This is an issue with use of the internet because providing links, for example, may cause the user to view an unapproved use listed on another site.)
  • Questions specific to Internet adverse event reporting (the submission of postmarketing adverse even reports are required by the FDA)

You can submit your comments online on http://www.regulations.gov. When you are on the site, use docket No. FDA-2009-N-0441 to identify your comment.

Tags: 

Read by 40,000+ device professionals worldwide.

Stay updated on changes to global medical device regulations.RADAR