By Carrie S. Martin –
On September 21, 2009, FDA announced in a Federal Register notice that the Agency plans to hold a public hearing to discuss issues regarding the promotion of FDA-regulated products – specifically prescription drugs, prescription biologics, and medical devices – via the Internet and social media. Many in industry feel that guidance from FDA on this issue is long overdue.
The meeting is intended to help FDA form its policy on the promotional of these products using the Internet and social media tools. Of particular interest to the Agency is how “Web 2.0” can be used to promote products in a truthful, non-misleading, and balanced manner to both consumers and health care professionals (“HCPs”). Web 2.0 includes new web development and design that facilitates interactive information sharing, such as social-networking sites (e.g., Facebook, Sermo), video-sharing sites (e.g., YouTube), wikis (e.g., Wikipedia), podcasts, blogs, and micro-blogs (e.g., Twitter). The hearing will not address nonprescription drug promotion.
FDA invites comments on the “general concept” of Internet promotion, any particular aspect of Internet promotion, and the following questions:
(1) For what online communications are manufacturers, packers, or distributors accountable? More specifically:
- What criteria should be applied to determine when third-party communications are subject to substantive influence by companies that market products related to the communications/discussions?
- When should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product?
- How should companies disclose their involvement or influence over discussions or material?
- Are there different considerations that should be weighed depending on the specific social media platform that is used or based on the intended audience?
- What is the experience to date with company communications being altered by third-parties?
(2) How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance) in their Internet and social media promotion, especially when some tools have space limitations or allow for real-time communications? More specifically:
- How should product information be presented to ensure that the user has access to a balanced presentation of risks and benefits?
- Are there data to support whether different types or formats of presentations have an impact on the public health?
- Are there ways to address regulatory concerns associated with space limitations or tools that allow for real-time communications to present product information?
- How should companies address the potential volume of information shared on various social media sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable?
(3) What parameters should apply to the posting of corrective information on Web sites controlled by third-parties? More specifically:
- Is there any data or research on how companies have approached these issues?
- Are there any criteria that could be used to determine how to correct misinformation on a Web site outside a company’s control?
- Should the parameters differentiate the prominence of the third-party site, its intended audience, its intended purpose, and/or the author of the information on the site?
(4) When is the use of the links appropriate? More specifically:
- What are appropriate techniques regarding the use of links (including between various social media tools) and is there data about whether or not users find these approaches to be misleading?
- Should parameters be established for links to and from Web sites?
- Is there data regarding how often users click on different categories of links (e.g., banner ads, sponsored links, organic search result links) to get additional information about products?
(5) Questions specific to Internet adverse event reporting, including:
- How are entities with post-marketing reporting responsibilities using the Internet and social media tools to monitor adverse event information?
- How is adverse event information from these sources being received, reviewed, and processed?
- What challenges are presented in handling adverse event information from these sources?
- What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?
The meeting is scheduled for November 12 and 13, 2009 (8 a.m. to 5 p.m. each day) at the National Transportation Safety Board Conference Center in Washington, D.C. Registration is required and must be submitted by October 9, 2009. Participation will be determined on a first-come, first-served basis.
To register or submit written comments, use the following address: Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Maryland 20852. Electronic registration and comments may be submitted via www.regulations.gov. FDA will accept public comments through February 28, 2010.