In line with FDA’s Transparency Task Force efforts, FDA is encouraging public comment on the Sentinel Initiative. The Sentinel Initiative is an FDA collaborative effort to develop a national electronic system (Sentinel System) that will transform FDA’s ability to track the safety of drugs, biologics, medical devices—ultimately all FDA-regulated products—once they reach the market.  By seeking public comment via an open discussion room, FDA is expanding its ability to get new ideas and guidance from the public in near real time. To contribute ideas on the Initiative and related documents, please visit http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.

On June 24, we held our first public meeting to hear ideas from the public about transparency at the agency.  During the meeting, some attendees told us that the FDA should use its website, www.fda.gov, to improve communications with the public. The task force would like continue this conversation and hear from more people about how FDA can use the website to be more effective in providing useful and understandable information to the public. 

Our question is:

How can FDA use its website to improve transparency at the agency?   

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

FDA Transparency Task Force

For those of you who are unable to attend the public meeting in person, the Task Force has made the meeting viewable via webcast. The link to the live program will not be active until June 24, 2009, at 7:30 AM ET. For details on the day's events please view the meeting's agenda.

We look forward to your participation.

Erik P. Mettler, MPA, MPH

FDA Transparency Blog Managing Director

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The sixth question is:

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

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

FDA Transparency Task Force

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The fifth question is:

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?

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

FDA Transparency Task Force

-  This public meeting is about transparency at FDA, how the agency can make understandable and useful information available to the public. Comments should be limited to this topic.

- Comments should be limited to 5 minutes to permit adequate time for questions from the panel and to allow time for an open comment session later in the day.  During the open comment session, attendees who did not register to speak can make comments.

-  Registered speakers will be organized into panels of three.  We have attempted to group registered speakers thematically, based on the brief description each speaker provided when he or she registered to speak.  Admittedly, this is an imperfect science and speakers in some groups may be speaking on different topics.  

- FDA panelists may ask questions to the panel after all three speakers finish delivering their comments.

- We are looking forward to a respectful discussion and exchange of ideas. 

- Under no circumstance shall a speaker be interrupted by another attendee at the conference. 

- Personal attacks or disparaging comments will not be permitted.

- Comments to the panel should be made only when at a microphone and you have been recognized by the Chair of the meeting.

- The public meeting is being webcast and there will be a verbatim transcript of the meeting publicly available. Do not share or reveal information you would not want to be public.

- In addition to the public meeting, there are other ways to provide comments to the task force.  You can post comments to this blog, submit written comments to the Division of Dockets Management, or submit electronic comments to Docket No. FDA-2009-N-0247 at www.regulations.gov.  Information about submitting comments to the task force can be found in the June 3, 2009 Federal Register Notice.

We look forward to your participation at the public meeting on June 24.

Afia Asamoah, JD, MPP
Public Meeting Coordinator

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The fourth question is:

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

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

FDA Transparency Task Force

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 24^th. 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