Answers to FDA’s Questions Regarding Pharma’s Use of Social Media (Survey started 12 May 2009; ended 28 October 2010. N=274 respondents)

FDA SM LogoThis survey solicited opinions on regulatory issues regarding Rx drug and device promotion via the Internet in general and social media in particular.

The Summary Report is now available here:

See Resources & Further Reading below…

Background On November 12-13, 2009, the FDA hosted a public hearing on the “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.” Over 60 speakers, mostly representing the interests of agencies, made presentations (see “Industry Groups will Eat Consumer Advocates’ Lunch at FDA Social Media Public Hearing“).

FDA will continue to receive written comments from the public through February 28, 2010, after which it is expected to issue draft guidance (see “FDA Social Media Guidelines Best Done in Baby Steps“). 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.

This 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.

Preliminary results of this survey was presented at the November hearing. Tom Abrams, director of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), expressed thanks for presenting specific solutions that the FDA could consider when it creates new guidelines for the promotion of FDA-regulated products on the Internet and social media sites.

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, 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 without your express permission.

Resources & Further Reading: