On August 11, 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.
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
You can share your comments on this topic on the FDA Transparency Blog.
Afia Asamoah is FDA Transparency Initiative Coordinator