(10/5/2009) FDA is planning a second public meeting 11/3 to flesh out comments on how to
ensure that information about certain agency activities and decision-making is useful, understandable, and accessible to the
public. Specifically, FDA wants detailed comments on three transparency areas:
Early communication about emerging safety issues concerning FDA-regulated products
Information disclosure 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be undertaken to have the application approved, or withdrawn by the applicant before approval
Agency communication decisions about pending product applications.
FDA formed a transparency task force earlier this year in response to President Obama’s call to provide a more open government. The first
public meeting in June heard ideas ranging from greater news media access to FDA staff to separate consumer and professional
Web portals to writing legal documents in consumer-friendly language and to opening up the transparency task force to outside
membership.
The task force is expected to make a report to commissioner Margaret Hamburg by year-end. FDA principal
deputy commissioner Joshua Sharfstein, who heads the internal task force, noted that the group has a very broad charge to
look at both the substance and form of information that can be more transparent to all stakeholders. He also pointed out that
a specific track has been established for agency employees to make known their suggestions for achieving greater transparency.
The meeting is scheduled for 9 a.m. to 3 p.m. at the National Transportation Safety Board Conference Center, 429
L’Enfant Plaza, S.W., Washington, D.C., 20594. To learn more, click here.
