Sunday, October 04, 2009

Should FDA Regulation Depend on Specific Media or Audiences? Survey says...

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:
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?
The survey asks respondents to choose ONLY one of the following responses (and add additional comments):
  • Yes
  • No
  • Don't Know
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.

Special Considerations

Many comments were submitted in response to this question. Some of these comments include:
  • Regulations should be harder on DTC communication and lighter or non-existent (beyond existing restraints) on physician/professional intended communications.
  • If a platform is a private group or a public discussion would maek a difference in the considerations.
  • Physician-only platforms should be treated differently than those open to consumers. Also, scientific data dissemination -- i.e. posting a link to an SDD press release -- should be evaluated as such, not as promotional materials. Third, allowances should be made for the limitations of platforms (e.g. Twtter's 140 character limit, space limits on search ad results, etc.).
  • Believe patients and caregivers should be able to "opt in" to pharmaceutical content. Some patients now more knowledgeable about their disease and the drug than physicians. They ought to be able to obtain any content and evidence they feel they need to be comfortable.
  • message size constraints should be taken into consideration.
  • If HCP based platform, that should fall into different parameters than if the SM site is with a public/consumer audience.
  • If guidance is platform-specific, Any guidance or guidelines will be irrelevant and out-of-date the day they are written
  • Balance, objectivity, imparciality, transparency are criteria that should guide any action no matter which platform is used.
  • Doctors, patients and other groups that may be targeted should be treated in the same manner; medical organizations should not be held accountable for comments on behalf of outsiders, as long as proper protocol for disclosure, disclaimer and transparency policies are clearly labeled on their sites and linked third-party sites.
  • When companies have involvement or influence over discussions or material presented on third-party sites it is more focused to an audience that a comment on a web blog made by an employee but both have the potential to provide product information or marketing.
  • Age: we need to stop advertising to the youth of america in order to satisfy corporate greed. Social media is one more way to indoctrinate people. My experience is that SM serves the organization in terms of PR, rather than serving as a robust, critical feedback mechanism from the consumer.
  • Twitter's format is simply too short for meaningful regulatory disclosures. Thus, bought-and-paid-for "Tweets (at a minimum), should be considered non-compliant advertising material by a manufacturer.
  • as with any other regulatory area, facts and circumstances will always be relevant in determining whether there is any deceptive practices going on
  • To a much greater degree than any other product (or service), prescription products (i.e., authorized by a qualified healthcare provider) should require regulation based on intended audience; basically, consumer versus provider.
  • If the outlet is only available to HCPs, there should be separate consideration.
  • The evolving and shifting nature of social media would make it unrealistic to develop different considerations for different social media platforms. It is better to try for guidelines that are generally applicable across different types of social media vehicles that attract varied audiences.
  • Available space (e.g., Twitter limitations) necessitates a difference in what is feasible.
  • Depending on platform: if it is push and no conversation is going to take place than different standards apply, however if conversation is going to be included and part than clearly need to define the scope of that conversation.
    In terms of timeliness in reviewing/posting comments on platforms such as Twitter, there should be different regulations vs. other platforms including Facebook, blogs, etc.
  • any platform that is not clearly marked as an advertisement or that the information provided was paid for by the company
    We should consider that platforms and audiences are not one size fits all and and weigh them as such. I don't necessarily have specific recommendations but with the evolution of social media, we don't want to pigeonhole ourselves into one regulatory story.
  • Should be possible to disclose in a manner consistent with social media platform -- space limitations or need for casual, personal tone. Standard should be to make a reasonable effort to disclose what ought to be disclosed in a way that fits a given platform or format.
  • guidelines on disclosure should apply to all social media and audience so that specific interest is clear.

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

Also see:

1 comment:

  1. When you think about it, Non-Personal Promotion is a horrible name. Who wants to be promoted to in an impersonal way? In the era of iTunes, Amazon, Expedia and Zappos, personalization is just not recommended; it will quickly become an expectation. For HCPs, this means personalizing the first “touch” with your known customers (e-mail or web-key for example) with content that is specific to their needs, then gleaning valuable data from their interactions with interactive promotion programs and what they request from a fulfillment perspective. This information can all be used to optimize your next “touch” (outbound e-mail, display ad, website landing page) with the customer.automateandvalidate


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