The link will not be active until November 3, 2009, at 8:30 AM ET. The webcast of the meeting will also be archived on the transparency task force website and can be viewed there 24 hours after the meeting. For details on the day's events, please view the meeting agenda, available here.

Afia Asamoah, Public Meeting Coordinator

- Each issue will be discussed by a stakeholder panel. Participants on each panel will discuss a hypothetical case study about the issue. Transparency task force members may ask questions of the panel following the discussion.

- During the public comment period, audience members may comment for up to 2 minutes each about the case studies.
- We are looking forward to a respectful discussion and exchange of ideas.

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

- 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 Federal Register notice. We look forward to your participation at the public meeting on November 3.

Afia Asamoah, Public Meeting Coordinator

Upcoming Events: Task Force is Holding its Second Public Meeting on Transparency in November

The next public meeting on transparency will be held Tuesday, November 3, 2009. The task force plans to use a discussion group format to receive detailed and in-depth comments on three specific issues related to transparency at FDA. The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (i.e., no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications.

We look forward to you participation.

Transparency Task Force

Part of FDA's transparency initiative is to better explain to the public what the agency does, in a useful, and user-friendly format. The task force would like your help in coming up with a list of questions about the FDA that you would like answers to. For example, possible questions can include: What products does FDA regulate? How do you find out if a medicine is approved by FDA? Your suggestions will be used by the task force to develop a FDA 101 curriculum for consideration by Commissioner Hamburg.

On August 18, FDA announced in the Federal Register that the docket for the transparency task force, available at

www.regulations.gov

, is re-opening for more comments until November 6, 2009.

When the agency announced the formation of the Transparency Task Force, in addition to launching the blog, the task force opened a public docket to solicit comments from the public on improving transparency at the agency. As of August 7, when the docket officially closed, we had received over 900 comments from a range of people -- consumers, patients, healthcare professionals, regulated industry, and others. The task force will use these comments to inform recommendations about transparency at the agency that will be provided in a report to Commissioner Hamburg in about five months.

The task force greatly appreciates the input and feedback it has received to date. Due to our desire to keep hearing from the public on this issue and to assist us in planning the second public meeting in the fall, the task force has decided to re-open the public docket for comments. In addition to commenting on the blog, you can provide longer and more detailed comments on the docket until November 6, 2009.

Keep the suggestions coming! And thanks for your ideas and comments to date.

Transparency Task Force

On August 14, Afia Asamoah, coordinator of the agency's transparency initiative, spoke to the Risk Communication Advisory Committee (RCAC) on behalf of the Transparency Task Force. The task force asked the RCAC for thoughts about how the agency can best communicate information to the public about different types of product recalls. The RCAC shared their thoughts about: (1) when the agency should communicate to the public about a product recall, (2) what the agency should say about the recall, and (3) how the agency should communicate to different stakeholders--patients, consumers, healthcare professionals, industry, and others--about a product recall. The RCAC also provided ideas about the importance of tracking whether the agency is doing a good job communicating to the public about product recalls.

We want to know what you think so we are asking you the same question we asked the RCAC. The question we asked the RCAC, and are asking you is:

Some risks require FDA monitoring and action but are not serious public health hazards.  How can we communicate about them effectively and transparently, and avoid causing unnecessary alarm?

We look forward to your participation.

Erik P. Mettler, MPA, MPH

FDA Transparency Blog Managing Director

On August 11, the White House Office of Science, Technology, and Policy (OSTP) hosted a meeting with FDA Principal Deputy Commissioner, Dr. Joshua Sharfstein, United States Chief Technology Officer, Aneesh Chopra, members of the White House Open Government Initiative, and the health care investor community at the White House to discuss ways FDA can make useful and understandable information available about the product approval process and how transparency at FDA can foster medical product innovation. Participants included individuals who invest in small, mid-size, and large companies that develop a range of products regulated by FDA. During the conversation, participants provided feedback to FDA and OSTP in three main areas: (1) how FDA can better explain its processes and operations, (2) what information would be helpful for FDA to provide to sponsors that submit product applications to the agency, and (3) how transparent processes at FDA can foster product development and innovation.

The comments shared during this meeting will be used to inform FDA's work of developing the recommendations about how to improve transparency and open government at the agency. Those recommendations will be delivered to Dr. Margaret Hamburg, FDA Commissioner, in approximately five months.

Afia Asamoah, FDA Transparency Initiative Coordinator

The views and opinions expressed in this comment are those of the author only and should not be regarded as those of the Transparency Task Force or FDA. The comment is posted by the Transparency Task Force simply to facilitate discussion.

My recommendation relates to cases where FDA does not approve one of the indications requested in a New Drug Application (NDA) or does not approve an indication requested in a Supplemental New Drug Application.  In such cases, FDA should make public the “non-approval letter” explaining why the indication was not approved, the relevant analysis by FDA’s medical officer and all clinical trials that were the basis for FDA’s non-approval. When a drug is marketed for at least one approved indication, it is foreseeable it will also be prescribed off-label for related indications, especially in cases where approval of the off-label indication has been sought.  A recent example with negative public health implications was Bextra® (valdecoxib), a drug withdrawn from the market for safety reasons.

As a Senior Assistant Attorney General in the Consumer Protection section of the Oregon Department of Justice, I led an investigation by a coalition of 34 State Attorneys General regarding the off-label promotion of Bextra to treat acute and perioperative pain.  This matter was resolved with a Stipulated General Judgment filed in Marion County Circuit Court.  In our Complaint we alleged, among other things, that after FDA refused to approve an application to market Bextra for acute and perioperative pain, the drug company went ahead and promoted these indications by distributing hundreds of thousands of copies of a positive study from the NDA without discussing or presenting a negative study from the NDA that was the basis for FDA’s refusal to approve.  Had FDA made public the non-approval letter, the analysis by the FDA medical officer assigned to review the NDA, and the relevant clinical trials, it would have been more difficult, if not impossible, to promote the drug off-label for these indications.

David Hart

Sr. Assistant Attorney General

Oregon Department of Justice

Civil Enforcement Division

The Transparency Task Force is trying something new. Every once in a while, we will post a comment we have received on this main page. The Task Force would like to hear from more people about the views expressed in these comments. These comments will be from a diverse group of stakeholders and each comment will present a view about transparency at FDA. We will ask the author before reposting the comment here.

The views and opinions expressed in these comments are those of the authors only and should not be regarded as those of the Transparency Task Force or FDA. The comments are posted by the Transparency Task Force simply to facilitate discussion.

The first posting is from Jeffrey Francer of the Pharmaceutical Research and Manufacturers of America.

The Pharmaceutical Research and Manufacturers of America (PhRMA) is highly supportive of the FDA’s transparency initiative, because transparency fosters accountability. It is important to acknowledge that the FDA is already one of the most transparent public health agencies in the world. It is hard to imagine any other similar government agency that provides on its web page all of its: approval letters, warning letters, advisory committee briefing materials, summary bases of approval, internal standard operating procedures, guidance documents, regulations, citizen petitions, as well as product-specific details on risk management programs and emerging safety information.

That said, the FDA’s mission requires that we make sure that the agency is communicating to healthcare professionals and the public as effectively as possible. PhRMA believes that the FDA can do even more to explain its approval decisions and other important regulatory actions to healthcare professionals and to patients. Put simply, FDA should make it obvious, to those who are interested, how scientific data leads to its approval decisions.

At the same time, it is critical to balance increased transparency with the need to encourage biopharmaceutical manufacturers to develop important medical advances in a competitive manner. Simply put, increased disclosure requirements that fail to protect innovative research and development investments will harm, rather than help improve, the public health. PhRMA looks forward to continuing the dialog begun by the FDA’s Transparency Task Force at its public meeting last week

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.