Friday, September 18, 2009

BREAKING NEWS: The FDA calls for a public hearing to discuss promotion of FDA-regulated medical products using the Internet and social media tools

This could perhaps be one of the most significant developments in healthcare marketing that I have witnessed in the past 10 years. The FDA is calling an official hearing to discuss medical product communications -- specifically in the context of the Internet, Web 2.0, and Social Media. This is a must read for anyone interested in helping shape the future of our industry.

The following statement, an extract from the notice, perfectly captures the significance of this event.

The FDA writes:

"The continually evolving nature of the Internet, including Web 2.0 and social media tools, as well as their expansion to applications such as mobile technology, have raised questions and concerns over how to apply existing regulations to promotion in these newer media. FDA is evaluating how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer technologies.

Although the agency believes that many issues can be addressed through existing FDA regulations, special characteristics of Web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied."

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Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing

Food and Drug Administration, HHS.

Notice of public hearing; request for comments.

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), is announcing a public hearing to discuss issues related to the 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 the 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.

Dates and Times: The public hearing will be held on November 12 and 13, 2009, from 8 a.m. to 5 p.m. each day. Submit written or electronic registration by close of business on October 9, 2009. Written and electronic comments will be accepted until February 28, 2010.

Location: The public hearing will be held at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594, 2023146305; Metro: L'Enfant Plaza station on the yellow, green, orange, and blue lines; see:

(FDA has verified the Web site address, but FDA is not responsible for any changes to the Web site after this document publishes in the Federal Register.)

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