Dennis D. McDonald (ddmcd@outlook.com) is an independent consultant located in Alexandria Virginia. His services and capabilities are described here. Application areas include project, program, and data management; market assessment, digital strategy, and program planning; change and content management; social media; and, technology adoption. Follow him on Google+. He also publishes on CTOvision.com and aNewDomain.

How Transparent is the new FDA Transparency Blog?

By Dennis McDonald, Ph.D.

The US Food and Drug Administration (FDA) has established a Transparency Task Force. One of its first public facing activities is the creation of the FDA Transparency Blog.

This is what the Task Force page says about the blog:

Provides opportunities to learn and provide feedback on what FDA is doing, the basis for FDA’s decisions, and the processes used to make agency decisions. The blog will run for the next six months (June through November 2009).

This is the comment I posted on the blog which reflects my desire to know who is at the other end of the communication channel:

I would appreciate seeing the names and faces of the people of the FDA staff who will be managing and moderating this process. Part of any transparency effort, I feel, is making clear who is responsible for managing the process; names and pictures — and contact information — will help in this regard.

A public meeting is planned for June 24 to discuss FDA transparency issues. The blog will be used to post, on a weekly basis, questions listed in the June 3 Federal Register announcement as input to the upcoming meeting. Here are the questions for the public meeting that are listed in the Federal Register announcement:

1. How can the agency better explain its operations, activities, processes, and decisionmaking?

2. What specific information should FDA provide about agency operations, activities, processes, and decisionmaking, including:
    a. Enforcement actions?
    b. Product approvals?
    c. Recalls?
    d. Other actions?

3. What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information?
    a. Internet tools?
    b. Tools to improve targeting and effectiveness of communications, including risk communication?
    c. Improvements to the Freedom of Information Act processes?
    d. Other?

4. What, if any, legislative or regulatory changes are needed to improve FDA’s ability to provide useful and understandable information to the public?

5. As FDA becomes more transparent, what information should remain confidential in order to promote key internal and external policy  goals, such as preserving patient privacy, and how, in these cases, should FDA explain the importance of confidentiality?

6. What metrics should FDA use to gauge the effectiveness of its transparency efforts?

I expect a lot of input on these questions from many of the public and private interest groups touched by FDA.

Making the blog part of this transparency process is a great idea. Still, there are some kinks to work out in terms of how the blog relates to the totality of communication processes that are channeling through the FDA. For example, if you read the Federal Register announcement about the June 24 meeting, you’ll see a very explicit description of how to submit comments in advance of the June 24 public meeting, either on paper (via mail) or electronically (by email).

There’s no mention of the blog. Does that mean that anything submitted via the blog will not be taken as seriously as input submitted via the mail and email channels outlined in the Federal register announcement? And how do comments on the blog differ from comments submitted to Regulations.gov?

I’m also interested in seeing the names and contact information listed of the members of the Transparency Board and of the people who are moderating the blog. For example, is the blog being managed by FDA staff or by contractors? That might be an important distinction in situations where policy is discussed.

All in due time, I suppose. Also, I suspect that this Transparency Blog won’t disappear in November as planned but that it will evolve into an ongoing group of communication programs associated with all of FDA’s externally facing processes. That means, of course, that rules and policies governing secrecy, formal versus informal communication, legal discoverability, confidentiality, and other transparency-related issues will need to be addressed — and that’s what this process is all about.

Copyright (c) 2009 by Dennis D. McDonald.

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