Should FDA Convene a Public Hearing on Use of Social Media by Pharma?

Survey began 2 April 2009

See Resources & Further Reading below…
It seems that the FDA and some pharma companies are “mulling” this over behind closed doors Web 2.0 rules (see April issue of MM&M). Shouldn’t we make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders?

What do you think?

Before you take this survey, let’s explain FDA’s procedures for developing and issuing guidance documents, using its own words (see here for the full text):

What is a guidance document?
“Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue.”

“Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops.”

Emphasis is placed on “can” because FDA doesn’t always seek or accept input form the public, as in:

“FDA will not seek your comment before it implements a Level 1 guidance document if the agency determines that prior public participation is not feasible or appropriate.”

Do you agree that the FDA should seek public participation BEFORE issuing guidance? There is a precedent for holding a public hearing on Internet issues prior to issuing guidance (see here). However, the FDA chose NOT to issue any Internet guidance after that public hearing.

When the FDA goes the non-public route in issuing guidance, here’s the procedure:

“FDA publishes a notice in the Federal Register announcing that the guidance document is available; it posts the guidance document on the Internet and makes it available in hard copy; it immediately implements the guidance document; and it invites your comment when it issues or publishes the guidance document. …If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate.”

The Survey
This survey presents you with several different procedures the FDA could use to develop guidance for the use of social media for the promotion of drugs and other medical products it regulates. These are:

  1. Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.
  2. FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.
  3. FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.
  4. If FDA solicits public comments — no matter in what fashion — it should publish ALL the comments it receives.

Please take the survey and indicate your level of agreement or disagreement with the above options/statements. Be sure to add comments as well. Thank you.

Results of this survey will be summarized in Pharma Marketing News. After you complete the survey, you will be able to see the summary yourself. No comments or other identifying information is included in the summary.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.

Take the survey here.

Resources & Further Reading:

  • Overcoming Barriers to Pharma’s Engagement in Social Networks
  • An ePharma Pioneer Club roundtable discussion on what it’s going to take to enable pharmaceutical marketers to engage in social networks without fear of adverse event reporting and other regulatory, corporate, and cultural roadblocks. Aired LIVE on Wednesday, April 8, 2009. More details, plus audio archives…

  • FDA Issues First-ever Draft Guidance on Pharma’s Use of Social Media! – an April Fool’s joke that got the juices flowing!

  • FDA and Pharma – Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!

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