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Sunday, September 20, 2009

Let's Respond to FDA's Questions Regarding Its Regulation of Social Media

On Friday, September 18, 2009, the FDA filed a notice to be published in the Federal Register on September 21, 2009 calling for a public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools:
Docket No. FDA-2009-N-0441, CDER 200994. Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Notice of public hearing; request for comments). Public Hearing on November 12, 2009 And November 13, 2009 Comments due February 28, 2010. (See "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!")
The FDA is requesting the public to submit comments to a series of specific questions, which are included in a new survey created by Pharma Marketing Network. Find the survey here.

This survey includes these main sections (pages):
  1. Introduction
  2. Questions About You (affiliation, support of industry, etc.)
  3. Issue 1: Accountability
    • What parameters or criteria should be applied to determine when third-party communications occurring on the Internet and through social media technologies are subject to substantive influence by companies that market products related to the communication or discussion?
    • In particular, when should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products?
    • How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites?
    • Are there different considerations that should be weighed depending on the specific social media platform that is used or based on the intended audience? If so, what are these considerations?
    • With regard to the potential for company communications to be altered by third parties, what is the experience to date with respect to the unauthorized dissemination of modified product information (originally created by a company) by noncompany users of the Internet?
  4. Issue 2: Fulfilling Regulatory Requirements
    • How should product information be presented using various social media tools to ensure that the user has access to a balanced presentation of both risks and benefits of medical products?
    • Are there data to support conclusions about whether different types or formats of presentations have a positive or negative impact on the public health?
    • Are there proposed solutions that may help address regulatory concerns when using social media tools 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?
  5. Issue 3: Posting Corrective Information
    • The agency is interested in any data or research on how companies have approached these issues related to posting of corrective information.
    • Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?
    • Should the parameters differentiate with regard to the prominence of the third-party site (i.e., readership), its intended audience (e.g., general public, health care professionals, patients), its intended purpose (e.g., personal diary, encyclopedia-type reference), and/or the author of the information on the site?
  6. Issue 4: Links
    • The agency is interested in any comments about the appropriateness of various techniques regarding the use of links (including between various social media tools) and data or research about whether or not users find these approaches to be misleading.
    • Should parameters be established for links to and from Web sites?
    • The agency is interested in any data or research concerning the frequency with which users actually click on different categories of links (e.g., banner ads, links within Web sites, sponsored links, organic search result links) to get additional information about products.
  7. Issue 5: Adverse Event Reporting
    • How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?
    • 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?
  8. Opt In Choice
  9. Thank You and Summary of Results
Many questions are pre-programmed with answers that you can select. As the survey progresses, other choices may be added to the list of answers. These additional choices will come from reviewing comments made to each question. It is important, therefore, that you include comments with any additional choices. Results of this survey may be summarized in Pharma Marketing News. After you complete the survey, you will be able to see a summary of responses, not including comments or other identifiable information about respondents. Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally. It is hoped that by participating in this survey you will learn more about the issues and use what you learn to submit an official comment to the FDA. Find the survey here.

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