7 October 2009

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
WANTED: Answers to FDA’s Questions Regarding Pharma’s Use of Social Media
5-minute survey:

Background On Monday, September 21, 2009, the FDA published a notice in the Federal Register announcing 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. Public Hearing on November 12, 2009 And November 13, 2009 Comments due February 28, 2010. The FDA is requesting the public to submit comments to a series of specific questions, which are included in this survey/comment form hosted by Pharma Marketing News. It asks respondents to answer all 19 questions posed by FDA in its public notice (see Resources & Further Reading below). Here’s your chance to speak your mind and respond anonymously to FDA’s plan to regulate Rx promo using social media!

The survey includes the following sections:

  1. Introduction
  2. Questions About You (affiliation, support of industry, etc.)
  3. Issue 1: Accountability
  4. Issue 2: Fulfilling Regulatory Requirements
  5. Issue 3: Posting Corrective Information
  6. Issue 4: Links
  7. Issue 5: Adverse Event Reporting
  8. Opt In Choice
  9. Thank You and Summary of Results

Sections 3 through 7 include the 19 questions FDA included in its public notice. Many of these questions, however, are pre-programmed with answers that respondents may select. Respondents may also insert comments and supply their own answers. As the survey progresses, other pre-programmed choices will be added based upon answers submitted in comments.

The goal of this survey is to obtain both quantitative and qualitative answers to the questions posed by the FDA. As the survey progresses, results will be (and have been) summarized on Pharma Marketing Blog and in Pharma marketing News (see Resources & Further Reading below).

In addition, Pharma Marketing News has officially requested to present the up-to-date findings of this survey at the November public hearing. It is hoped that by presenting results of this survey at the November hearing, more people will participate in answering the questions. The entire survey responses database, including open-ended comments, will be submitted into the docket when the survey is completed just prior to the February, 2010 comment submission deadline. No personal information, however, will be included.

Take the Survey Please take 5 minutes to answer this survey soliciting your opinion on regulatory issues regarding Rx drug and device promotion via the Internet in general and social media in particular. Take the survey here.

You will be able to see a summary of up-to-date de-identified results upon completion of the survey.

Results of this survey may be summarized in an issue of Pharma Marketing News.

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. Your personal information, however, will not be included in any summary posted to the FDA public hearing docket.

Resources & Further Reading:

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