FDA Transparency Blog

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

Attendees

Transparency Meeting with Investors & FDA

August 11, 2009, 9:30 – 11:00am, EEOB 350

Barry Eisenstein, Cubist

Scott Minick, ARCH

Jonathan Flemming, Oxbio

John H. Griffin, Numerate, Inc.

Mike Ross, SV Life Sciences

Michael Doherty, Genentech

Vern Norviel, WSGR

Jonathan Fleming, Oxford Bioscience Partners

William Rosenzweig, Physic Ventures

Jonathan S. Leff, Warburg Pincus

Kelly Slone, NVCA

Justin Klein, NEA