In preparation for FDA’s public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see “Let’s Respond to FDA’s Questions Regarding Its Regulation of Social Media“). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:

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?

The survey asks respondents to choose one or more of the following responses (and/or add additional comments):

  • Marketer or agent paid for an ad on the page that is displayed based on the content of the page (eg, Google Adword on content sites)
  • Marketer or agent paid for the content (eg, paid blogger or Tweeter to write about product)
  • Any communication by anyone that is employed by, or is a consultant of, the manufacturer should be held accountable.
  • None of the above

The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

Substantive Influence over Content
Many comments were submitted in response to this question. Some of these comments include:

  • In some cases the marketer can pay for content and not influence its content. This is CME and CE.
  • Any communication UNDERTAKEN ON BEHALF OF THE COMPANY by anyone that is employed by, or…
  • Content supplied by physician or healthcare professional that may have been paid or otherwise compensated/rewarded by pharma company.
  • Total transparency is imperative.
  • Key word in number two is paid. If a company provides a sample but does not pay the blogger, the company should not be held liable for what that blogger (or reporter or patient) says/writes.
  • Any communication by anyone that is employed by, or is a consultant of, the manufacturer should be held accountable.
  • If there is a contractual relationship between the communicator and the manufacturer by which the communicator receives any monetary or non-monetary benefit from the manufacturer.
  • The consumer needs to know clearly what Internet contents/communications are company controlled (and therefore regulated) versus all other content.
  • As long as there is a disclosure agreement and standards for conversation listed on the third-party site, those hosting the conversation should not be held liable for outside opinions expressed through the avenue they provide. Therefore, companies are only responsible for the output from those they pay to attribute to the sites they host on social media networks.
  • Marketer or agent built or created the social media site/community tool for the sole use of the company
  • If the blogger/tweeter has been paid to write about a product this information should be disclosed. I am hesitating over the 3rd point. There is so much variation in communication, I worry that a blanket “be held accountable” would have unforseen repercussions.
  • Pharmaceuticals are an opaque good. Thus, pharma companies should have contractual provisions to control the messaging — and ensure the balance and accuracy — of all messaging offered by any agent pharma retains, hires, employs or contracts with.
  • Substantive influence could also include non-monetary influences such as “wining and dining” or inviting bloggers to events or hiring bloggers as “consultants.”

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media
Also see: