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Archive for June, 2009

Response to Some Comments

June 16, 2009 18 comments

In response to a few of the comments that have come in we have added a new section to the “About This Blog” page. On that page you will now find a description of the Task Force’s Actions and Membership. We will also provide a webcast of the Public Meeting on the 24th. The link to the webcast will provided here in a separate post as well as on the Task Force website. The webcast will also be available for viewing online after the public meeting.

If you have any other suggestions on how we can improve this blog and make it more useful please let us know.

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

The Transparency Task Force’s Second Question

June 14, 2009 16 comments

We want to know what information FDA could give to the public to better explain the agency’s work and its decisions. The second question is:

What specific information should FDA provide about agency operations, activities, processes, and decision making, including:

  • Enforcement Actions?
  • Product Approvals?
  • Recalls?
  • Other Actions?

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

Transparency Public Meeting Structure and Format

June 8, 2009 17 comments

We are seeking advice on the best way to structure the June 24, 2009 public meeting on transparency.

The agency typically organizes public meetings by the order in which presenters submit their speaking requests to the agency.  This approach has varied results as it can be difficult to locate a particular meeting or to review comments associated with a particular topic after the meeting.  We have come up with additional options below for organizing the June 24 public meeting and we are interested in your input.

  • By Product (e.g., drugs/biologics, medical devices, foods, cosmetics, dietary supplements)
  • By Agency Action (e.g., review of product applications and product approvals, enforcement actions, recalls, public education and outreach to stakeholders)
  • By Question posed in the Federal Register notice

Thank you in advance for your help and advice.

FDA Transparency Task Force

The Transparency Task Force’s First Question

June 4, 2009 64 comments

The Transparency Task Force is actively seeking input from the public about issues related to transparency and will work to identify what information the public most wants FDA to be transparent about.  The public comments will inform the recommendations the Task Force will provide to the Commissioner about ways the agency can become more transparent.

To fully utilize this blog and help categorize and focus the conversations on it we will post a new question and/or topic every week until the Transparency Task Force public meeting is held on Wednesday, June 24, 2009. We will begin by posting, one at a time, the questions we asked in the Federal Register notice we published on June 3, 2008.

 

The first question is relatively general.  Still, we really would like to hear everyone’s initial thinking on it:

How can the agency better explain its operations, activities, processes and decision making?

Thank you.  We look forward to your input and participation.  We also encourage you to attend the public meeting and send comments to the “docket.” 

FDA Transparency Task Force

Introducing the FDA Transparency Blog

June 2, 2009 292 comments

I want to thank Peggy Hamburg and the team at FDA for their leadership and work to make the FDA open and transparent.

Our Administration is committed to eliminating the barriers between the American people and their government, and the Task Force is another big step in the right direction.

The FDA is responsible for protecting the food we eat and the medicine we use — its work impacts every American, and ensuring the agency is open and accountable to the American people is critical.

Thank you for taking the time to visit the Task Force blog and learn more about this effort.  We appreciate your thoughts and ideas and look forward to hearing from you.

Sincerely,

Secretary Kathleen Sebelius 
U.S. Department of Health and Human Services

Background
Providing information to the public in a user-friendly and timely manner is critically important to the work of the agency and its credibility with the public.  I have formed a Transparency Task Force, chaired by Principal Deputy Commissioner Dr. Joshua Sharfstein, to provide me with recommendations about how to make FDA and its processes more transparent to the public.

If you have a suggestion about how to improve transparency at the agency, I encourage you to let the Task Force know by submitting or responding to a comment in the blog provided below.

In addition to this blog you can also submit electronic comments to the federal register at www.regulations.gov, submit written comments to the Division of Dockets Management, or attend a public meeting on Wednesday, June 24, 2009 in downtown DC with some members of the Task Force.  Additional details about how you can engage with the Task Force can be found here. The first blog post is to inform you of this process and our policy.  Thereafter, we will be asking for you feedback on specific topics.

Thank you for your input and participation.

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs

Comment Policy
This is a moderated blog. We expect that participants will treat each other with respect. All comments will be reviewed before posting. We will not post comments that contain vulgar or profane language; personal attacks of any kind; or offensive terms that target specific ethnic, religious or racial groups. We will not post comments that are clearly off topic, spam, or that promote services or products. Comments that make unsupported accusations will also not be posted.

Reporters are asked to send questions to the FDA Media Office through their normal channels and to refrain from submitting questions here as comments. Reporter questions will not be posted.

We recognize that the Web is a 24/7 medium, and your comments are welcome at any time.  However, given the need to manage federal resources, moderating and posting of comments will occur during regular business hours Monday through Friday.  Comments submitted after hours or on weekends will be read and posted as early as possible the next business day.

For the benefit of robust discussion, we ask that comments remain on-topic.

To protect your own privacy and the privacy of others, please do not include phone numbers or email addresses in the body of your comment.

Thank you for taking the time to read this comment policy. We encourage your participation in our discussion and look forward to an active exchange of ideas.

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