Friday, October 09, 2009

How Should Pharma Companies Submit Social Media Content for FDA Approval?

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:
How should companies address the potential volume of information shared on various social media sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable.
The survey asks respondents to choose one or more of the following responses (and add additional comments):
  • FDA Should Audit Social Media sites on regular basis -- eg, yearly (requires mandatory registration of sites with FDA)
  • Drug company should submit only content that it is responsible for (ie, created directly or paid a 3rd party to create) as soon as that content is posted (no submission of non-company content)
  • Drug company should submit only content that that it creates (ie, created directly or paid a 3rd party to create) upon first use of social media site, then periodic -- eg, monthly -- submissions afterward (no submission of non-company content)
  • Submit Social Media Site 'template' (design and/or sample content) to FDA for pre-approval/approval.
  • Something Else (submit your idea in next question)
  • Can't Be Done
  • Don't Know
The image below shows how respondents answered this question (ALL respondents vs. PHARMA 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.
How to Submit SM Content for FDA Approval

Many comments were submitted in response to this question. Some of these comments include:
  • Content not directly influenced by the company should not require submission to the FDA. Only content directly developed or paid for by the company should be submitted.
  • create a definition of a "representative sample" of information shared on various social media sites. this can be submitted on a regular (monthly, quarterly) basis. In addition to this, FDA could conduct yearly audits.
  • They should make a good faith effort to submit what is authored by them and paid for by them
  • develop templates and get pre approval for FDA
  • Information will be initially screened through a social media contact of each company or division (as deemed by medical organizations) and aggregated each week to be filtered through the regulatory process as necessary. Social media contacts will need to be well-versed on company policies and FDA regulations to sufficiently pre-screen comments and real-time conversations. After internal regulation is complete, companies that are generally responsible for responding to the FDA should submit materials through the web on a bi-weekly basis.
  • I think the point should not be to control all the volume of information but to provide official channels for the patients and/or health care professionals to report any relevant information.
  • FDA should set up a social media information repository that reviews material solely used for social media on a different timeline than traditional content.
    one common reporting service - required by law to be integrated per the Schroeder Plan
  • Companies should be held accountable for ensuring systems are in place to regularly monitor/review information from social media sites. However, the concept that such information be considered 'spontaneously' reported and de facto 'related' and subject to collection and reporting rules needs to be revisted. Also in some cases, the concept of an 'identifiable' reporter is questionable, as is the opportunity for follow-up and obtaining meaningful information. Monitoring such information should be considered part of active/pro-active surveilance, but not subject to standard safety processing.
  • If the company has no part in creating the environment or content, the company should not be held accountable for submitting. If the company creates the environment, appropriate disclaimers regarding the source of the postings should be prominent and submission for postings made by non company contributors with no payment should not be required. Any comments posted by company or paid for by company should be submitted with appropriate DOFU.
  • That's a great question, and one for which I do not have the answer. The major limitation of the internet is that anyone can say anything at any time about a product/company. Who's to say it isn't going to be cases of corporate sabotage?
    Companies should submit any promotional content that is not interactive (e.g. an initial blog post) at first use. Companies should then send scheduled updates (monthly?) with interactive content (e.g. Responses to comments posted on the site). Alternatively, each company could send the FDA information (including email addresses, the sites where they are authorized to post items, and their user names on those sites) enabling the agency to monitor information in real time.
  • If sponsored by the company - then they need to address and monitor. If user generated then should not be mandated.
    Pharma shouldn't promote the product and instead add value to patient by giving help and care
  • Whoever can answer that will be able to start a thriving consulting business
WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

1 comment:

  1. How about the FDA just publishes a general warning saying: Don't believe anything you read about any drug unless you absolutely know the source and its reputation. Anything else is foolishness. Then let anyone publish anything under the First Amendment and let tort law handle the mistakes.


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