FDA to Hold Part 15 Hearing on Social Media and Pharma – Finally!

This is nothing less than astounding.  The FDA is seeking input on social media and pharma.

The hearing will be held on November 12 and 13 in Washington DC.  Details are here.   

I have often railed against the DDMAC policies respecting the use of social media and the pharmaceutical industry, to the dismay of some, as have many others.  On Monday, the FDA is set to publish in the Federal Register that the agency will hold a meeting on that very topic.  

This is historic.  Pass the word.  This is a game changer.   Here is an excerpt – forgive the spacing issues:

Questions have arisen regarding the application of the prescription drug and
device advertising and labeling provisions, regulations, and policies of
promotion on the Internet, especially with regard to the use of emerging
technologies such as blogs, microblogs, podcasts, social networks and online
communities, video sharing, widgets, and wikis. This section briefly discusses
the issues the agency has identified as most frequently raised by regulated
companies and other interested parties. It should be noted that although a
question may raise a particular issue, that does not necessarily mean that the
agency will issue guidance or a regulation on that issue.
The agency invites comment at the public hearing on the general concept of
Internet promotion, positive or negative; on any aspect of Internet promotion
that is of interest to the presenter; and on the topics outlined in the
following paragraphs. We are specifically interested in data and research on the
use of social media tools in promotion, including data from companies on their
own experiences, the extent to which health care professionals and consumers are
using and are influenced by various social media tools, and the impact of
Internet and social media promotion on the public health.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in FDA Policy, New and Social Media. Bookmark the permalink.

One Response to FDA to Hold Part 15 Hearing on Social Media and Pharma – Finally!

  1. Yes, this is wonderful news. Just in case someone wants to review the full Federal Register article regarding the social media public hearing, here’s the citation:
    74 FR 48083 — Sep. 21, 2009
    FDA source: http://www.FederalRegister.com