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U.S. Department of Health and Human Services

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Summary of Listening Sessions with Industry

Overview

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On January 21, 2009, President Obama instructed executive departments and agencies to take appropriate action, consistent with law and policy, to disclose information to the public rapidly, and in a form that is easily accessible and user friendly. In response, FDA formed an internal Transparency Task Force to develop recommendations for making useful and understandable information about FDA activities and decision-making more readily available to the public in a timely manner and in a user-friendly format, in a manner compatible with the agency's goal of protecting confidential information, as appropriate. The Task Force is responsible for guiding FDA’s Transparency Initiative, which is divided into 3 phases: (1) creating a Web-based resource called “FDA Basics,” that will provide information about commonly misunderstood agency activities and frequently asked questions; (2) improving FDA’s disclosure of information to the public; and (3) improving FDA’s transparency to regulated industry.

Phases 1 and 2 are well underway. To begin its process of gathering information for phase 3, FDA invited members of regulated industry to a series of sessions at which the Transparency Task Force would listen to industry suggestions for improving FDA’s transparency to regulated industry. To obtain a group of representative companies, FDA wrote to trade associations representing the following industries: human and animal drugs, biological products, conventional foods, dietary supplements, and medical devices. Each trade association was asked to identify three individuals from their organization or member companies to participate in the listening sessions. The three listening sessions were held on January 21, 27, and 28, 2010.

Summaries of the listening sessions are provided below. FDA is also announcing in the Federal Register that it is requesting public comment on improving transparency to regulated industry, and making available the transcripts of the listening sessions as well as these summaries.