FDA announced a public hearing to be held on November 12-13, 2009. The agency is asking for public comments on “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools” (see “Let’s Respond to FDA’s Questions Regarding Its Regulation of Social Media“).

The FDA has asked 19 specific questions that it would like input on (see link above). To help get the discussion going, I’ve put all these questions in a survey (here), which I hope will help you formulate your own comments for submission to the FDA while seeing what others have to say.

In this post I’d like to start the discussion around FDA’s first 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?

In the survey, I suggested a couple of parameters that I thought are relevant to this question:

  1. 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)
  2. Marketer or agent paid for the content (eg, paid blogger or Tweeter to write about product)

Keep in mind, I included these choices in the survey ONLY as starting points. If you have any others, please let me know by including them in the comment section of the survey or comments to this post. I will then add them as additional parameters so that survey respondents can vote on them.

A related question is:  How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites?

A couple of options, include:

  • Disclosure is necessary only when content is paid for.
  • Disclosure should be prominently displayed alongside relevant content when possible

It’s easy to determine when a marketer pays for an ad that runs alongside user-generated content on social network sites that accept advertising. According to common practice, such ads should be labeled “advertisement,” as is the case with ads appearing on this blog page.

Of course, unethical sites may not include the notice and then it becomes a matter of interpretation whether the information is a paid ad or not, especially if it is worded and formatting in such a way as to look like content. This matter was discussed long ago in what seems like a galaxy far far away by the Internet Healthcare Coalition (no disbanded), which developed the eHealth Code of Ethics.

The second point — paying someone to write content in a social media setting — is definitely having “substantive” influence over the content. Not disclosing this fact is adding insult to injury. I am sure that this has happened in the past and may still be happening. Example can be found here: “Alli Ad Campaign Promises Honesty, But Does It Deliver?

Although I can’t prove it, I sense that there are paid agents of the pharmaceutical industry out there whose job it is to pose as consumers or patients on social network sites and post messages that essentially marketing messages.

It’s nearly impossible for the FDA to regulate that sort of thing other than to provide guidelines that state any such messages from paid agents should include a disclosure notice that the person writing the message is an employee of a pharmaco or of an agency hired by a pharmaco.

No one will know for certain when such a guideline or regulation is violated, but if a violation is ever revealed — by an investigative reporter, for example — then the FDA could act. more importantly, however, every pharmaceutical company should have its own guidelines on such issues and make them PUBLICLY available, just like they do with their privacy policies.

How about this: FDA guidance should include a statement that says each pharmaco must have a SM policy that includes a notice of transparency…yadda, yadda, yadda [YOU CAN PROVIDE THE DETAILS in comments to the survey here: http://bit.ly/GgW14]

Related issues: