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Transparency Task Force - Approach

View PDF of the Transparency Task Force Section (47 KB)


Background

Transparency Report ArrowApproach

Progress to Date and Future Plans


Approach
 

To solicit public input on improving Agency transparency, the Task Force held two public meetings, launched an online blog, and opened a docket to which comments could be submitted.

At the first public meeting, the Task Force solicited comments on how the Agency could improve transparency overall.  Thirty five individuals provided comments during the meeting and 335 people attended in person or watched the live webcast of the eight hour session.

At the second public meeting, the Task Force solicited comments on three specific issues related to transparency at the Agency: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of Agency decisions about pending product applications. Sixteen individuals participated in the groups convened to discuss each issue as well as during the open public session.  One hundred seventy four people attended the meeting in person or watched the live webcast.

The online blog and the docket have received 1,572 comments.  The blog has offered an opportunity for exchange about specific ideas for transparency at the agency.

The Task Force also solicited feedback from FDA’s Risk Communication Advisory Committee about communicating to the public about product recalls and emerging safety issues with FDA-regulated products.

Dr. Sharfstein attended a listening session, hosted by the White House Office of Science and Technology, to hear comments from the health care investor community on how transparency at FDA can foster investment in the life sciences and medical product innovation.

The Task Force reviewed the comments received from all of these stakeholders consumers, patients, regulated industry, health care providers, investors, and others.  The comments were used by the Task Force to inform the draft proposals for public comment in this report.  The Task Force also identified ways to improve transparency that are reflected in this report.

The draft proposals for public comment contained in this report have not yet been fully analyzed or prioritized by the Task Force. FDA is seeking public input on the draft proposals set forth in this report.  FDA cannot implement the proposals at once, so as a result, FDA is seeking public input not only on the content of the proposals but on how the Agency should prioritize the proposals which are selected for implementation.

The Task Force will review public comments received about each draft proposal and conduct a more in-depth analysis of what will be needed to implement each proposal, including resource requirements, information technology infrastructure, whether changes to statutes or regulations are needed, and operational feasibility, in order to arrive at proposals the Task Force will recommend for implementation.